GUIDE NO. AERB/RF/SG/G-3 (Vol.

2 of 4)
GUIDE NO. AERB/RF/SG/G-3 (Vol. 2 of 4)

GOVERNMENT OF INDIA

AERB SAFETY GUIDE

CONSENTING PROCESS
FOR
RADIATION FACILITIES

(VOLUME - 2)

ATOMIC ENERGY REGULATORY BOARD

 Price

Order for this guide should be addressed to:

Chief Administrative Officer

Atomic Energy Regulatory Board
Niyamak Bhavan
Mumbai-400 094
India
 FOREWORD

Activities concerning establishment and utilisation of nuclear facilities and use of

radioactive sources are to be carried out in India in accordance with the provisions of
the Atomic Energy Act, 1962. In pursuance of the objective of ensuring safety of
members of the public and occupational workers as well as protection of the
environment, the atomic energy regulatory board (AERB) has been entrusted with the
responsibility of laying down safety standards and enforcing rules and regulations for
such activities. The Board, therefore, has undertaken a programme of developing safety
standards, codes and related guides and manuals for the purpose. While some of these
documents cover aspects such as siting, design, construction, operation, quality
assurance and decommissioning of nuclear and radiation facilities, other documents
cover regulatory aspects of these facilities.
Safety codes and standards are formulated on the basis of nationally and internationally
accepted safety criteria for design, construction and operation of specific equipment,
systems, structures and components of nuclear and radiation facilities. Safety codes
establish the objectives and set requirements that shall be fulfilled to provide adequate
assurance for safety. Safety guides elaborate various requirements and furnish
approaches for their implementation. Safety manuals deal with specific topics and
contain detailed scientific and technical information on the subject. These documents
are prepared by experts in the relevant fields and are extensively reviewed by advisory
committees of the Board before they are published. The documents are revised when
necessary, in the light of experience and feedback from users as well as new
developments in the field.
AERB issued a safety code on ‘Regulation of Nuclear and Radiation Facilities’ (AERB/
SC/G) to spell out the requirements/obligations to be met by a nuclear or radiation
facility for the issue of regulatory Consent at every stage. This safety guide apprises
the details of the regulatory requirements for setting up the radiation facility. such as
consenting process, the stages requiring consent, wherever applicable documents to
be submitted and the nature and extent of review. The guide also gives information on
methods of review and assessment adopted by AERB.
Consistent with the accepted practice, ‘shall’ and ‘should’ are used in the guide to
distinguish between a firm requirement and a desirable option respectively. Appendices
are an integral part of the document, whereas annexures, bibliography and list of
participants are included to provide further information that might be helpful to the
user. Approaches for implementation different to those set out in the guide may be
acceptable, if they provide comparable assurance against undue risk to the health and
safety of the occupational workers and the general public, and protection of the
environment.
For aspects not covered in this guide, applicable national and international standards,
codes and guides acceptable to AERB should be followed. Non-radiological aspects

i
such as industrial safety and environmental protection are not explicitly considered in
this guide. Industrial safety shall be ensured by compliance with the applicable
provisions of the Factories Act, 1948 and the Atomic Energy (Factories) Rules, 1996.
The guide has been prepared by AERB staff. It has been reviewed by experts and the
Advisory Committee on Preparation of Code and Guides and on Governmental
Organisation for Nuclear and Radiation Facilities (ACCGORN).
AERB wishes to thank all individuals and organisations who have prepared and
reviewed the draft and helped in its finalisation. The list of experts, who have
participated in this task, along with their affiliations, is included for information.

(S. S. Bajaj)
Chairman, AERB

ii
 DEFINITIONS

Acceptable Limits
Limits acceptable to the regulatory body for accident condition or potential exposure.
Accelerator
A device in which, charged particles are accelerated. Conventional X-ray tube is not
considered as an accelerator.
Activity
The quantity ‘A’ for an amount of radionuclide in a given energy state at a given time,
defined as:
A = dN/dt
where, ‘dN’ is the expectation value of the number of spontaneous nuclear
transformations from the given energy state in a time interval ‘dt’. The SI unit of
activity is the reciprocal of second, (s-1), termed the Becquerel (Bq).
Afterloading Applicator
A device applied to the patient into which radioactive sources are introduced either
manually or by a remotely operated system.
Applicant
Any person who, applies to the competent authority for consent to undertake any of
the actions for which the consent is required.
Approval
A type of consent issued by the regulatory body to a proposal.
Atomic Energy Regulatory Board (AERB)
A national authority designated by the Government of India having the legal authority
for issuing regulatory consent for various activities related to the nuclear and radiation
facility and to perform safety and regulatory functions, including their enforcement
for the protection of site personnel, the public and the environment against undue
radiation hazards.
Authorisation
A type of regulatory consent issued by the regulatory body for all sources, practices
and uses involving radioactive materials and radiation generating equipment (see also
‘Consent’).
Becquerel
See ‘Activity’

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Betatron
An electron accelerator in which electrons are accelerated in an increasing magnetic
field maintaining a stable orbit of electrons.
Commissioning
The process during which structures, systems and components of a nuclear and radiation
facility, on being constructed, are made functional and verified to be in accordance
with design specifications and to have met the performance criteria.
Competent Authority
Any official or authority appointed, approved or recognised by the Government of
India for the purpose of the Rules promulgated under the Atomic Energy Act, 1962.
Computed Tomography
Reconstructive tomography in which image recording and processing are effected by
a computing system.
Consent
It is a written permission issued to the ‘consentee’ by the regulatory body to perform
specified activities related to nuclear and radiation facilities. The types of consents
are ‘licence’, ‘authorisation’, ‘registration’, and ‘approval’ and will apply according
to the category of the facility, the particular activity and radiation source involved.
Consentee
A person to whom consent is granted by the competent authority under the relevant
Rules.
Construction
The process of manufacturing, testing and assembling the components of a nuclear or
radiation facility, the erection of civil works and structures, the installation of
components and equipment and the performance of associated tests.
Contamination
Presence of a radioactive substances in or on a material or in the human body or other
place in excess of quantities specified by the competent authority.
Cyclotron
A device in which charged particles (other than electrons) travel in a succession of
semicircular orbits of increasing radii under the influence of a constant magnetic field
and are accelerated by traversing a number of times in an electric field produced by a
high frequency generator.
Decommissioning
The process by which a nuclear or radiation facility is finally taken out of operation, in

iv
a manner that provides adequate protection to the health and safety of the workers, the
public and the environment.
Decontamination
The removal or reduction of contamination by a physical or chemical means .
Disposal
The emplacement of a waste in a repository without the intention of retrieval or the
approved direct discharge of waste into the environment with subsequent dispersion.
Dose
A measure of the radiation absorbed by a target. The quantities termed absorbed dose,
organ dose, equivalent dose, effective dose, committed equivalent dose or committed
effective dose are used, depending on the context. The modifying terms are used when
they are not necessary for defining the quantity of interest.
Dosimeter
A device, instrument or system, which can be used to measure or evaluate any quantity
that can be related to the determination of either absorbed dose or equivalent dose.
Dosimetry
Measurements and/or calculations performed in connection with the determination of
radiation dose and/or dose distributions in the irradiated volume.
Employer
Any person with recognised responsibility, commitment and duties towards a worker
in his or her employment by virtue of a mutually agreed relationship. (A self-employed
person is regarded as being both a worker and employer).
Enclosed Installation
In case of industrial radiography any installation in which radiography operations are
carried out in an enclosure which has walls providing adequate radiation protection to
persons working outside the enclosure, and which prevents unauthorised entry of
persons into the enclosure during radiography operations. Such installations may include
open top installations also.
Ethical Review Committee
A committee of independent, qualified persons to advise on the conditions of exposure
and the dose constraints to be observed for individuals exposed for biomedical research
when there is no direct benefit to the exposed individual.
Fluoroscopy
The technique of imaging by using a fluorescent screen.
Handle

v
Manufacture, possess, store, use, transfer by sale or otherwise export, import, transport
or dispose of.
Industrial Gamma Radiography Exposure Device (IGRED)
An assembly of components necessary to make radiographic exposures and which
includes the source housing, mechanism for securing the source assembly, exposure
mechanism, that includes source drive associated system, positioning devices and guide
tubes.
Industrial radiography
Non-destructive testing of materials employing ionising radiation.
Ionisation
Formation of ions by the division of molecules or by the addition or removal of electrons
from atoms or molecules.
Irradiation
Exposure to ionising radiation.
Irradiators
A facility that houses a particle accelerator, X-ray machine, or large radioactive sources
for imparting high radiation doses to materials.
Licence
A type of regulatory consent, granted by the regulatory body for all sources, practices
and uses for nuclear facilities involving the nuclear fuel cycle and also certain categories
of radiation facilities. It also means authority given by the regulatory body to a person
to operate the above said facilities.
Limit
The value of a parameter or attribute (which is variable) used in certain specific activities
or circumstances that must not be exceeded.
Luminescence
Phenomenon in which certain substances, when excited, emit light of wavelength
characteristic of the substance.
Microtron
A cyclic accelerator in which electrons are guided by a constant magnetic field in
circular orbits of increasing radii, tangential to each other and accelerated at the
beginning of each orbit, by traversing an electric field produced by a radio frequency
generator.
Monitoring

vi
The continuous or periodic measurement of parameters for determination , assessment
in respect of structure, system or component in a facility or control of radiation.
Nuclear Medicine
The speciality that utilises radio-pharmaceuticals to investigate disorders of anatomy,
physiology and patho-physiology, for diagnosis and/or treatment of diseases.
Package
The packaging with its radioactive contents as prescribed for transport.
Personnel Monitoring
Determination or estimation of the dose received by a person from external and internal
radiation.
Practice
Any human activity that introduces additional sources of exposure or exposure pathways
or extends exposure to additional people or modifies the network of exposure pathways
from existing sources, so as to increase the exposure or the likelihood of exposure of
people, or the number of people exposed.
Prescibed Limits
Limits established or accepted by the regulatory body.
Protective Barrier or Shielding (Radiation)
A barrier of appropriate thickness used to reduce radiation levels to specified values.
Protective Device
Device used for the purpose of radiological protection.
Quality Assurance
Planned and systematic actions necessary to provide adequate confidence that an item
or a facility will perform satisfactorily in service as per the design specifications.
Radiation
Gamma rays, X-rays or rays consisting of alpha particles, beta particles, neutrons,
protons, and other nuclear, sub-atomic particles, but not sound or radio waves, or
visible, infrared, ultraviolet light.
Radiation Facility
Any installation/equipment or a practice involving use of radiation-generating units
or radioisotopes in the field of research, industry, medicine and agriculture.
Radioactive Waste
Material, whatever its physical form, remaining from practices or interventions and
for which no further use is foreseen. It can be (a) that contains or is contaminated with

vii
radioactive substances and has an activity or activity concentration higher than the
level for clearance from regulatory requirements, and (b) exposure to which is not
excluded from regulatory control .
Radioactive Waste Management Facility
Facility specifically designed to handle, treat, condition, temporarily store or
permanently dispose of radioactive waste.
Radioactivity
The phenomenon whereby atoms undergo spontaneous random disintegration, usually
accompanied by the emission of radiation.
Radiography (Medical)
Technique for obtaining, recording and optionally processing, directly or after transfer,
information contained in an X-ray pattern at an image receptor area.
Radiography Source
A source sealed in one or more capsules, or an X-ray tube, or an electron accelerator
or a neutron source used for industrial radiography.
Radiography Technician/Radiography Technologist/Radiographer
A worker, who performs radiography operations employing radiography sources and
possesses a valid qualification, duly recognised by the competent authority for the
specific purpose.
Radiological Safety Officer (or Radiation Safety Officer)
Any person who is so designated by the employer and who, in the opinion of the
competent authority, is qualified to discharge the functions outlined in the Atomic
Energy(Radiation Protection )Rules, 2004.
Radiotherapy/Radiation Therapy
Medical treatment by ionising radiation.
Registration
A type of regulatory consent issued by the regulatory body for all sources, practices
and uses involving radioactive materials and radiation generating equipment.
Regulatory Body
See ‘Atomic Energy Regulatory Board’
Safety Assessment
Review of the aspects of design and operation of a source, which are relevant to the
protection of persons or the safety of the source, including the analysis of the provisions
for safety and protection established in the design and operation of the source and the
analysis of risks associated with normal conditions and accident situations.

viii
Safety Site-in-charge
A person who has the qualifications and training prescribed for Level 2 radiological
safety officer and who is appointed by the ‘consentee’ as the person supervising
industrial radiography operations at an authorised radiography site with approval of
the competent authority.
Sealed Source
Radioactive source material that is (a) permanently sealed in a capsule or (b) closely
bounded and in a solid form. The capsule or material of a sealed source shall be strong
enough to maintain leak tightness under the conditions of use and wear for which the
source was designed, as also under foreseeable mishaps.
Source
Any thing that causes radiation exposure, either by emitting ionising radiation or
releasing radioactive substances or materials.
Source Changer
A device for transferring radiography sources from or to exposure device, and suitable
for transport and storage of the source.
Source Housing
Shielding provided in any device containing a sealed source, in order to:
(i) define the useful beam; and
(ii) limit the radiation level outside of the useful beam to maximum permissible
leakage levels, as specified by the competent authority.
Synchrotron
Particle accelerator in which charged particles travel in circular orbits of constant
radius guided by an increasing magnetic field and accelerated by traversing a number
of times an electric field produced by a high frequency generator in synchronism
with the orbital motion.
Teletherapy
Treatment with external radiation beam(s) where the distance from source to skin is
greater than 5 cm.
Tomography
Radiography of one or more sections/layers within an object.
Treatment Planning (Radiotherapy)
Planning of the techniques for radiation therapy, which may include treatment simulation
and dosimetry.

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Treatment Simulation
Methods by which the techniques and patient positioning for radiotherapy are simulated
without delivering the therapy dose.
Type Approval
Approval, issued by the competent authority, based on evaluation of the device to
ensure that it conforms to safety standards.
Type A package
A Package designed to withstand normal conditions of transport without loss or dispersal
of its contents or loss of shielding integrity. The radioactive material may be transported
in a Type A package, either in special form radioactive material or other form, with the
provision that the activity shall not exceed the applicable limits prescribed in the relevant
code on ‘Transport of Radioactive Materials’.
Type B(U) package
A package designed to contain an activity in excess of A1, if special form radioactive
material, or in excess of A2 if not special form radioactive material, that is designed to
withstand normal and accidental conditions of transport specified in the relevant code
on ‘Transport of Radioactive Materials’.
Unusual Occurrence
Any occurrence which has the potential to impair or impairs the plant safety, radiological
safety, industrial safety and/or environmental safety.

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 SPECIAL DEFINITIONS
(Specific for the Present Guide)

Consumer Product
A manufactured product or item containing radioactive substance, which is exempted
from regulatory control.
Field Radiography
Radiography operations carried out on shop floors, erection sites or other such areas
with provisions for adequate radiological safety for the radiography personnel and
others including members of the public.
Person
Any individual, or a company, or association, or body of individuals, whether
incorporated or not; or central government or a state government.
Worker
Any person who works, whether full-time, part-time or temporarily, for an employer
and who has recognised rights and duties in relation to occupational radiation protection.
(A self-employed person is regarded as having the duties of both an employer and a
worker).
X-ray Equipment
Equipment consisting of combination of an X-ray generator, X-ray tube and associated
equipment.

xi
 CONTENTS

FOREWORD ....................................................................... i

DEFINITIONS ....................................................................... iii

SPECIAL DEFINITIONS ....................................................................... xi

Volume - 1

1. INTRODUCTION ..................................................................... 1
1.1 General ....................................................................... 1
1.2 Objective ...................................................................... 1
1.3 Scope ....................................................................... 2

2. CLASSIFICATION OF CONSENTS AND CONSENTING

PROCESS ....................................................................... 3
2.1 General ....................................................................... 3
2.2 Statutory Provisions for Regulatory Consents ............. 3
2.3 Stages of Consenting Process ...................................... 3
2.4 Regulatory Consenting Procedures .............................. 4
2.4.1 General .......................................................... 4
2.4.2 Consent for Siting .......................................... 4
2.4.3 Consent for Construction/Layout
Plan Approval ................................................ 5
2.4.4 Consent for Commissioning .......................... 5
2.4.5 Consent for Operation ................................... 5
2.4.6 Consent for Decommissioning/Disposal ....... 6
2.4.7 Renewal of Consent for Operation/
Type Approval/RSO ...................................... 6
2.4.8 Review and Assessment Process ................... 7
2.5 Licence ....................................................................... 7
2.5.1 Consent for Operation ................................... 7
2.5.2 Consents, Review Process and Lead
Time at Various Stages .................................. 8
2.6 Authorisation ................................................................ 10
2.6.1 Authorisation for Operation .......................... 10
2.6.2 Consents, Review Process and Lead
Time at Various Stages .................................. 10
2.6.3 Authorisation for Waste Disposal/
Decommissioning .......................................... 11
2.7 Registration .................................................................. 11
2.7.1 Registration of Equipment/Laboratories ....... 11
 2.7.2 Consents, Review Process and Lead
Time at Various Stages .................................. 12
2.8 Consent/Approval ........................................................ 12
2.8.1 Type Approval for Source(s), Equipment,
Devices and Packages ................................... 12
2.8.2 Safety Manpower Approval .......................... 13
2.8.3 Consents/Approval, Review Process
and Lead Time ............................................... 13
2.9 Exemption .................................................................... 14
2.10 Renewal of Consent ..................................................... 14

3. INFORMATION REQUIREMENTS FOR CONSENTING .... 15

3.1 General ....................................................................... 15
3.2 Land-Based High Intensity Radiation
Processing Facilities (other than Gamma
Irradiation Chambers) .................................................. 15
3.2.1 Gamma Radiation Processing Facility
(GRAPF) ....................................................... 15
3.2.1.1 General .......................................................... 15
3.2.1.2 Site Assessment and Approval ..................... 15
3.2.1.3 Layout and Construction Approval ............... 16
3.2.1.4 Commissioning .............................................. 17
3.2.1.5 Operation ....................................................... 17
3.2.1.6 Decommissioning/Disposal ........................... 19
3.2.1.7 Lead Time for Submission/Availability
of Documents ................................................ 19
3.2.2 Industrial Accelerator Radiation
Processing Facility (IARPF) ......................... 19
3.2.2.1 General .......................................................... 19
3.2.2.2 Site Assessment and Approval ...................... 19
3.2.2.3 Layout and Construction Approval .............. 19
3.2.2.4 Commissioning .............................................. 21
3.2.2.5 Operation ....................................................... 21
3.2.2.6 Decommissioning/Disposal ........................... 22
3.2.2.7 Lead Time for Submission/Availability
of Documents ................................................ 22
3.3 Particle Accelerator Research facilities (PARF) .......... 22
3.3.1 General .......................................................... 22
3.3.2 Site Assessment and Approval ...................... 23
3.3.3 Layout and Construction Approval ............... 24
3.3.4 Commissioning .............................................. 24
3.3.5 Operation ....................................................... 25
3.3.6 Renewal of Consent for Operation ................ 26
3.3.7 Decommissioning/Disposal ........................... 26
 3.3.8 Lead Time for Submission/Availability
of Documents ................................................ 27
3.4 Facilities Engaged in the Commercial Production
of Radioactive Material and Radiation Generating
Equipment .................................................................... 27
3.4.1 Medical Cyclotron Facility ........................... 27
3.4.1.1 General .......................................................... 27
3.4.1.2 Site Assessment and Approval ...................... 27
3.4.1.3 Layout Plan and Construction Approval ....... 28
3.4.1.4 Commissioning and Operation ...................... 28
3.4.1.5 Decommissioning .......................................... 29
3.4.1.6 Lead Time for Submission/Availability
of Documents ................................................ 29
3.4.2 Facilities Engaged in the Commercial
Production of Radiation Generating
Equipment ..................................................... 30
3.4.2.1 General .......................................................... 30
3.4.2.2 Layout Plan Approval (of Testing
Laboratory) .................................................... 30
3.4.2.3 Construction .................................................. 30
3.4.2.4 Licence for Commercial Production/
Manufacturing ............................................... 30
3.4.2.5 Lead Time for Submission/availability
of Documents ................................................ 31
3.4.3 Integrated Facility for Radiation
Technology (IFRT) ........................................ 31
3.4.3.1 General .......................................................... 31
3.4.3.2 Site Assessment and Approval ...................... 31
3.4.3.3 Layout and Construction Approval ............... 32
3.4.3.4 Commissioning and Operation ...................... 33
3.4.3.5 Decommissioning/Disposal ........................... 34
3.4.3.6 Lead Time for Submission/Availability
of Documents ................................................ 34
3.5 Telegamma and Accelerators Facilities used in
Radiation Therapy ........................................................ 34
3.5.1 Telegamma Radiation Therapy Facility ........ 34
3.5.1.1 General .......................................................... 34
3.5.1.2 Site and Layout Plan Approval ..................... 35
3.5.1.3 Construction .................................................. 35
3.5.1.4 Procurement of Source/Equipment ............... 36
3.5.1.5 Commissioning and Operation ...................... 36
3.5.1.6 Decommissioning/Disposal ........................... 38
3.5.1.7 Lead Time for Submission/Availability
of Documents ................................................ 38
 3.5.2 Medical Linear Accelerator Facility ............. 38
3.5.2.1 General .......................................................... 38
3.5.2.2 Site and Layout Plan Approval ..................... 38
3.5.2.3 Construction .................................................. 39
3.5.2.4 Procurement of Medical Linear
Accelerator .................................................... 39
3.5.2.5 Commissioning and Operation ...................... 40
3.5.2.6 Decommissioning/Disposal ........................... 41
3.5.2.7 Lead Time for Submission/Availability
of Documents ................................................ 41
3.6 Computed Tomography/Interventional Radiology
(Cath Lab) .................................................................... 41
3.6.1 General .......................................................... 41
3.6.2 Site and Layout Plan Approval ..................... 42
3.6.3 Construction .................................................. 42
3.6.4 Procurement .................................................. 42
3.6.5 Commissioning and Operation ...................... 42
3.6.6 Lead Time for Submission/Availability
of Documents ................................................ 43
3.7 Radiography ................................................................. 43
3.7.1 Industrial Radiography .................................. 43
3.7.1.1 General .......................................................... 43
3.7.1.2 Procurement of Source/Device for
Radiography .................................................. 43
3.7.2 Enclosed Radiography Installations .............. 44
3.7.2.1 General .......................................................... 44
3.7.2.2 Site, Layout Plan and Construction ............... 45
3.7.3 Open Field Radiography ............................... 45
3.7.3.1 Commissioning and Operation ...................... 46
3.7.3.2 Decommissioning/Disposal ........................... 46
3.7.3.3 Lead Time for Submission/Availability
of Documents ................................................ 47
3.7.4 Industrial Accelerator Facility (IAF)
for NDT ......................................................... 47
3.7.4.1 General .......................................................... 47
3.7.4.2 Site, Layout Plan and Construction
Approval ........................................................ 47
3.7.4.3 Commissioning and Operation ...................... 48
3.7.4.4 Decommissioning/Disposal ........................... 49
3.7.4.5 Lead Time for Submission/Availability
of Documents ................................................ 49
3.8 Brachytherapy Facilities .............................................. 49
3.8.1 General .......................................................... 49
3.8.2 Site and Layout Plan Approval ..................... 50
 3.8.3 Construction .................................................. 50
3.8.4 Procurement of Sources ................................ 50
3.8.5 Commissioning and Operation ...................... 51
3.8.6 Decommissioning/Disposal ........................... 52
3.8.7 Lead Time for Submission/Availability
of Documents ................................................ 53
3.9 Gamma Irradiation Chamber (GIC) ............................. 53
3.9.1 General .......................................................... 53
3.9.2 Procurement of GIC ...................................... 53
3.9.3 Commissioning and Operation ...................... 54
3.9.4 Decommissioning/Disposal ........................... 54
3.9.5 Lead Time for Submission/Availability
of Documents ................................................ 54
3.10 Nuclear Medicine Facilities ......................................... 55
3.10.1 Nuclear Medicine Therapy Facility .............. 55
3.10.1.1 General .......................................................... 55
3.10.1.2 Site and Layout Plan Approval/
Design of facility ........................................... 55
3.10.1.3 Construction .................................................. 55
3.10.1.4 Commissioning and Operation ...................... 55
3.10.1.5 Decommissioning/Disposal ........................... 56
3.10.1.6 Lead Time for Submission/Availability
of Documents ................................................ 57
3.10.2 In-vivo Nuclear Medicine Diagnostic
Facility ........................................................... 57
3.10.2.1 General .......................................................... 57
3.10.2.2 Site and Layout Plan Approval ..................... 57
3.10.2.3 Construction .................................................. 57
3.10.2.4 Commissioning and Operation ...................... 57
3.10.2.5 Decommissioning/Disposal ........................... 58
3.10.2.6 Lead Time for Submission/Availability
of Documents ................................................ 58
3.11 Facilities Engaged in the Commercial Production
of Nucleonic Gauges and Consumer Products
Containing Radioactive Materials ............................... 58
3.11.1 Facilities Engaged in the Commercial
Production of Nucleonic Gauges (NGs)/
Ionising Radiation Gauging Devices
(IRGDs) ......................................................... 58
3.11.1.1 General .......................................................... 59
3.11.1.2 Site and Layout Plan Approval ..................... 59
3.11.1.3 Commissioning and Operation ...................... 59
3.11.1.4 Decommissioning/Disposal ........................... 60
 3.11.1.5 Lead Time for Submission/Availability
of Documents ................................................ 60
3.11.2 Facilities Engaged in the Commercial
Production of Consumer Products
Containing Radioactive Materials ................. 60
3.11.2.1 General .......................................................... 60
3.11.2.2 Site and Layout Plan Approval ..................... 60
3.11.2.3 Commissioning and Operation ...................... 61
3.11.2.4 Disposal ......................................................... 61
3.11.2.5 Lead Time for Submission/Availability
of Documents ................................................ 61
3.12 Radioactive Sources in Well Logging.......................... 61
3.12.1 General .......................................................... 61
3.12.2 Procurement of Source(s) ............................. 62
3.12.3 Commissioning/Operation............................. 62
3.12.4 Disposal ......................................................... 63
3.12.5 Lead Time for Submission/Availability
of Documents ................................................ 63
3.13 Medical Diagnostic X-ray Equipment including
Therapy Simulator ........................................................ 63
3.13.1 Radiotherapy Simulator................................. 63
3.13.1.1 General .......................................................... 63
3.13.1.2 Site and Layout Plan approval ...................... 64
3.13.1.3 Construction .................................................. 64
3.13.1.4 Procurement of Radiotherapy Simulator ....... 64
3.13.1.5 Commissioning and Operation ...................... 65
3.13.1.6 Lead Time for Submission/Availability
of Documents ................................................ 66
3.13.2 Medical Diagnostic X-ray Equipment .......... 66
3.13.2.1 General .......................................................... 66
3.13.2.2 Site and Layout Plan Approval ..................... 66
3.13.2.3 Construction .................................................. 66
3.13.2.4 Procurement .................................................. 66
3.13.2.5 Commissioning and Operation ...................... 67
3.13.2.6 Lead Time for Submission/Availability
of Documents ................................................ 67
3.14 Baggage Inspection System ......................................... 67
3.14.1 General .......................................................... 67
3.14.2 Safety Assessment and Approval .................. 67
3.14.3 Lead Time for Submission/Availability
of Documents ................................................ 68
3.15 Nucleonic Gauges (NGs)/Ionising Radiation
Gauging Devices (IRGDs) ........................................... 68
3.15.1 General .......................................................... 68
 3.15.2 Procurement and Registration ....................... 68
3.15.3 Decommissioning/Disposal ........................... 69
3.15.4 Lead Time for Submission/Availability
of Documents ................................................ 70
3.16 Research Applications using Radioisotopes ................ 70
3.16.1 Sealed Rdioisotopes in Research and
Calibration ..................................................... 70
3.16.1.1 General .......................................................... 70
3.16.1.2 Procurement and Registration ....................... 70
3.16.1.3 Disposal ......................................................... 71
3.16.1.4 Lead Time for Submission/Availability
of Documents ................................................ 71
3.16.2 Research Applications using Unsealed
Radioisotopes ................................................ 71
3.16.2.1 General .......................................................... 71
3.16.2.2 Layout Plan Approval ................................... 72
3.16.2.3 Commissioning and Operation ...................... 72
3.16.2.4 Decommissioning/Disposal ........................... 72
3.16.2.5 Lead Time for Submission/Availability
of Documents ................................................ 72
3.16.3 Biomedical Studies on Humans .................... 72
3.16.3.1 General .......................................................... 72
3.16.3.2 Commissioning and Operation ...................... 73
3.16.3.3 Lead Time for Submission/Availability
of Documents ................................................ 73
3.17 Radio-Immuno Assay (RIA) ........................................ 73
3.17.1 General .......................................................... 73
3.17.2 Layout Plan Approval ................................... 74
3.17.3 Commissioning and Operation ...................... 74
3.17.4 Lead Time for Submission/Availability
of Documents ................................................ 74
3.18 Consent/Type Approval ............................................... 74
3.18.1 Type Approval of Sources, Equipment,
Devices and Packages ................................... 74
3.18.2 Approval of Shipment for Radioactive
Consignment under Special Arrangement ..... 76
3.18.3 Safety Manpower Approval (i.e. RSO
Approval) ...................................................... 76
3.18.4 Lead Time for Submission/Availability
of Documents ................................................ 77
3.19 Channels of Communication ........................................ 77

4. REVIEW AND ASSESSMENT PROCESS .............................. 78

4.1 General ....................................................................... 78
 4.2 Consent for Site ............................................................ 78
4.3 Consent for Construction/Layout Plan Approval ........ 79
4.4 Consent for Commissioning ......................................... 79
4.5 Consent for Operation .................................................. 79
4.6 Renewal of Consent for Operation .............................. 81
4.7 Consenting Decisions ................................................... 81
4.8 Licence ....................................................................... 81
4.8.1 Review Process ............................................. 81
4.8.2 Assessment Process ....................................... 82
4.9 Authorisation ................................................................ 82
4.9.1 Review Process ............................................. 82
4.9.2 Assessment Process ....................................... 83
4.10 Registration .................................................................. 83
4.10.1 Review Process ............................................. 83
4.10.2 Assessment Process ....................................... 84
4.11 Consent/Approval ........................................................ 84
4.11.1 Type Approval of Sources, Equipment,
Devices, Packages and Approval of
Shipment ........................................................ 84
4.11.1.1 Review Process ............................................. 84
4.11.1.2 Assessment Process ....................................... 85
4.11.2 Safety Manpower Approval (i.e. RSO
Approval) ...................................................... 85
4.11.2.1 Review Process ............................................. 85
4.11.2.2 Assessment Process ....................................... 86
4.12 Codes and Guides as Reference Documents ............... 86

Volume - 2

APPENDIX-1 INDUSTRIAL SAFETY ............................... 87

(Refer section 2.2)

APPENDIX-2A FORMAT OF SITE ASSESSMENT

(Refer section 3.2.1.2) REPORT FOR GAMMA RADIATION
PROCESSING FACILITY (GRAPF) ........... 89

APPENDIX-2B FORMAT OF THE PRELIMINARY

(Refer section 3.2.1.3) SAFETY ANALYSIS REPORT FOR
GAMMA RADIATION PROCESSING
FACILITY (GRAPF)..................................... 92

APPPENDIX-2C FORMAT FOR THE ACCEPTANCE

(Refer section 3.2.1.4 ) TEST REPORT TO VERIFY
 FUNCTIONAL PERFORMANCE OF
SAFETY SYSTEMS/INTERLOCKS
FOR GRAPF ................................................. 98

APPPENDIX-2D FORMAT OF THE FINAL SAFETY

(Refer section 3.2.1.5) ANALYSIS REPORT FOR GAMMA
RADIATION PROCESSING
FACILITY (GRAPF)..................................... 109

APPENDIX-2E RADIATION PROTECTION MANUAL

(Refer section 3.2.1.4) OF GAMMA RADIATION
PROCESSING FACILITY (GRAPF) ........... 118

APPENDIX-2F QUALITY ASSURANCE MANUAL

(Refer section 3.2.1.5) (QAM) FOR GAMMA RADIATION
PROCESSING FACILITY (GRAPF) ........... 121

APPENDIX-3B-I FORMAT OF THE PRELIMINARY

(Refer section 3.2.2.3) SAFETY ANALYSIS REPORT FOR
INDUSTRIAL ACCELERATOR
RADIATION PROCESSING
FACILITY (IARPF) ...................................... 127

APPENDIX-3B-II FORMAT OF THE PRELIMINARY

(Refer section 3.3.1) SAFETY ANALYSIS REPORT FOR
PARTICLE ACCELERATOR
RESEARCH FACILITIES (PARF)
< 10MeV ....................................................... 133

APPENDIX-3B-III FORMAT OF THE PRELIMINARY

(Refer section 3.7.8.2) SAFETY ANALYSIS REPORT FOR
INDUSTRIAL ACCELERATOR
FACILITY (IAF) FOR NDT ......................... 139

APPENDIX-3C FORMAT FOR ACCEPTANCE TEST

(Refer section 3.2.2.4 REPORT (ATR) FOR ACCELERATOR
for IARPF and FACILITIES [IARPF, IAF-NDT AND
PARF<10 MeV) PARF < 10MeV] ........................................... 143
(Refer section 3.7.8.3
for IAF-NDT)

APPENDIX-3D-I & II FORMAT OF THE FINAL SAFETY

(Refer section 3.2.2.5) ANALYSIS REPORT FOR IARPF
(This format can also be used for PARF
with beam energy <10 MeV) ........................ 146
APPENDIX-3D-III FORMAT OF THE FINAL SAFETY
(Refer section 3.7.8.3) ANALYSIS REPORT FOR
INDUSTRIAL ACCELERATOR
FACILITY (IAF) FOR NDT ......................... 148

APPENDIX-3E FORMAT FOR RADIATION

(Refer section 3.2.2.5 PROTECTION MANUAL FOR ALL
for IARPF)(Refer ACCELERATOR FACILITIES
section 3.7.8.3 [IARPF, IAF-NDT AND PARF
for IAF-NDT) <10MeV] ....................................................... 150

APPENDIX-3F QUALITY ASSURANCE MANUAL

(Refer section 3.2.2.3 (QAM) FOR ACCELERATOR
for IARPF.) (Refer FACILITIES [IARPF, IAF-NDT,
sections 3.7.8.2 and PARF < 10MeV] ........................................... 152
3.7.8.3 for IAF NDT)

APPENDIX-4A FORMAT FOR SITE EVALUATION

(Refer section 3.3.2) REPORT FOR PARTICLE
ACCELERATOR RESEARCH
FACILITY (PARF>10MeV) ......................... 157

APPENDIX-4B, 4D FORMAT FOR (PRELIMINARY/

(Refer sections 3.3.3, FINAL) SAFETY ANALYSIS
3.3.4 & 3.3.5) REPORT FOR PARF/(>10MeV) .................. 159

APPENDIX-4C FORMAT FOR THE ACCEPTANCE

(Refer section 3.3.4) TEST REPORT (ATR) FOR
PARTICLE ACCELERATOR
RESEARCH FACILITIES
(PARF >10MeV) ........................................... 162

APPENDIX-4F QUALITY ASSURANCE (QA)

(Refer sections 3.3.2, MANUAL FOR PARTICLE
to 3.3.4) ACCELERATOR RESEARCH
FACILITY[PARF >10MeV] ......................... 164

APPENDIX-5B FORMAT OF THE PRELIMINARY

(Refer section 3.4.1.3) SAFETY ANALYSIS REPORT
(PSAR) FOR MEDICAL
CYCLOTRON FACILITIES ........................ 173

APPENDIX-5D FORMAT OF THE FINAL SAFETY

(Refer section 3.4.1.4) ANALYSIS REPORT (FSAR) FOR
MEDICAL CYCLOTRON FACILITIES ..... 180
APPENDIX-5E RADIATION PROTECTION MANUAL
(Refer section 3.4.1.4) FOR MEDICAL CYCLOTRON
FACILITIES .................................................. 188

APPENDIX-5F QUALITY ASSURANCE MANUAL

(Refer sections 3.4.1.3, (QAM) FOR MEDICAL
3.4.1.4) CYCLOTRON FACILITIES ........................ 190

APPENDIX-6A FORMAT FOR SITE ASSESSMENT

(Refer section 3.4.3.2) REPORT OF INTEGRATED
FACILITY FOR RADIATION
TECHNOLOGY (IFRT) ............................... 199

APPENDIX-6B FORMAT OF THE PRELIMINARY

(Refer section 3.4.3.3.) SAFETY ANALYSIS REPORT FOR
INTEGRATED FACILITY FOR
RADIATION TECHNOLOGY (IFRT) ......... 202

APPENDIX-6D FORMAT OF THE FINAL SAFETY

(Refer section 3.4.3.4) ANALYSIS REPORT FOR
INTEGRATED FACILITY FOR
RADIATION TECHNOLOGY (IFRT) ......... 210

APPENDIX-6E RADIATION PROTECTION MANUAL

(Refer section 3.4.3.4) OF INTEGRATED FACILITY FOR
RADIATION TECHNOLOGY (IFRT) ......... 219

APPENDIX-6F QUALITY ASSURANCE MANUAL

(Refer section 3.4.3.4 ) (QAM) FOR INTEGRATD FACILITY
FOR RADIATION TECHNOLOGY
(IFRT) ............................................................ 221

APPENDIX-7E RADIATION PROTECTION MANUAL

(Refer sections 3.5.1.5, OF RADIOTHERAPY FACILITY
3.8.4) (APPLICABLE FOR TELEGAMMA
AND BRACHYTHERAPY
FACILITIES) ................................................. 227

APPENDIX-8C-I ACCEPTANCE/PERFORMANCE/
(Refer section 3.6.3) QUALITY ASSURANCE TEST
FORCOMPUTED TOMOGRAPHY
(CT) SCANNER ........................................... 230
APPENDIX-8C-II ACCEPTANCE/PERFORMANCE/
(Refer sections 3.6.3 & QUALITY ASSURANCE TEST
3.13.2.5) FORDIAGNOSTIC X-RAY UNIT/
CATH LAB .................................................... 239

APPENDIX-8C-III ACCEPTANCE/PERFORMANCE/
(Refer section 3.13.2.5) QUALITY ASSURANCE TEST
FOR MAMMOGRAPHY UNIT ................... 247

APPENDIX-8E RADIATION PROTECTION MANUAL

(Refer section 3.6.3 ) (RPM) FOR DIAGNOSTIC X-RAY
FACILITIES INCLUDING
COMPUTED TOMOGRAPHY (CT)/
INTERVENTIONAL RADIOLOGY
INSTALLATIONS AND FACILITIES
ENGAGED IN THE COMMERCIAL
PRODUCTION OF RADIATION
GENERATING EQUIPMENT ..................... 254

APPENDIX-9E RADIATION PROTECTION MANUAL

(Refer section 3.7.5) FOR INDUSTRIAL RADIOGRAPHY
FACILITY ..................................................... 256

APPENDIX-10 LIST OF AERB, STANDARDS,

(Refer section 3.18.1) CODES AND GUIDES USED FOR
RADIATION FACILITIES ........................... 258

Volume - 3

ANNEXURE-1 APPLICATION FOR CONSENT FOR

(3.2.1.2) SITE APPROVAL OF LAND BASED
STATIONARY GAMMA RADIATION
PROCESSING FACILITY (GRAPF) ........... 261

ANNEXURE-2 APPLICATION FOR LAYOUT AND

(3.2.1.3) CONSTRUCTION APPROVAL OF
LAND BASED STATIONARY
GAMMA RADIATION PROCESSING
FACILITY (GRAPF)..................................... 265

ANNEXURE-3 APPLICATION FOR LICENCE FOR

(3.2.1.5) COMMISSIONING /OPERATION OF
LAND-BASED STATIONARY
 GAMMA RADIATION PROCESSING
FACILITY (GRAPF)..................................... 270

ANNEXURE-4 APPLICATION FOR OBTAINING

(3.2.1.5) THE CERTIFICATE OF APPROVAL
FOR AN IRRADIATION FACILITY ........... 275

ANNEXURE-5 APPLICATION FOR SITING,

(3.2.2.2 & 3.2.2.3) LAYOUT AND CONSTRUCTION
APPROVAL OF INDUSTRIAL
ACCELERATOR RADIATION
PROCESSING FACILITY (IARPF/
PARF < 10MEV) ........................................... 278

ANNEXURE-6 APPLICATION FOR LICENCE FOR

(3.2.2.5 & 3.2.2.6) COMMISSIONING/OPERATION OF
INDUSTRIAL ACCELERATOR
RADIATION PROCESSING
FACILITY (IARPF/PARF < 10MeV) ........... 282

ANNEXURE-7 APPLICATION FOR CONSENT FOR

(3.3.2) SITE APPROVAL OF PARTICLE
ACCELERATOR RESEARCH
FACILITY OF DAE (PARF > 10 MeV) ....... 287

ANNEXURE-8 APPLICATION FOR CONSENT FOR

(3.3.3) CONSTRUCTION OF PARTICLE
ACCELERATOR RESEARCH
FACILITY OF DAE (PARF > 10 MeV) ....... 291

ANNEXURE-9 FORMAT FOR APPLICATION FOR

(3.3.4) APPROVAL OF PERSON TO BE
DESIGNATED AS R S O
(FOR DAE PARF) ......................................... 295

ANNEXURE-10 APPLICATION FOR CONSENT FOR

(3.3.4) COMMISSIONING OF PARTICLE
ACCELERATOR RESEARCH
FACILITY OF DAE (PARF>10 MeV) ......... 297

ANNEXURE-11 APPLICATION FOR LICENCE FOR

(3.3.5) OPERATION OF PARTICLE
ACCELERATOR RESEARCH
FACILITY OF DAE (PARF>10 MeV) ......... 302
ANNEXURE-12 APPLICATION FOR CONSENT FOR
(3.4.1) SITE APPROVAL FOR LOCATION
OF MEDICAL CYCLOTRON
FACILITY ..................................................... 307

ANNEXURE-13 APPLICATION FOR CONSENT FOR

(3.4.1.3) LAYOUT AND CONSTRUCTION
APPROVAL FOR MEDICAL
CYCLOTRON FACILITY ............................ 311

ANNEXURE-14 APPLICATION FOR LICENCE FOR

(3.4.1.4) COMMISSIONING AND OPERATION
OF MEDICAL CYCLOTRON
FACILITY ..................................................... 314

ANNEXURE-15 APPLICATION FOR LAYOUT PLAN

(3.4.2.2) APPROVAL OF TESTING FACILITY
FOR RADIATION GENERATING
EQUIPMENT [FOR FACILITIES
ENGAGED IN COMMERCIAL
PRODUCTION OF COMPUTED
TOMOGRAPHY (CT)/INTERVEN-
TIONAL RADIOLOGY (CATH LAB)/
RADIOGRAPHY/RADIOGRAPHY AND
FLUOROSCOPY (R&F)/DENTAL/
ORTHO-PANTOMOGRAPHY (OPG)/
MAMMOGRAPHY/BONE
DENSITOMETER/MEDICAL X-RAY
TUBE AND TUBE HEAD] .......................... 320

ANNEXURE-16 APPLICATION FOR LICENCE FOR

(3.4.2.3) COMMERCIAL PRODUCTION OF
RADIATION GENERATING
EQUIPMENT [COMPUTED
TOMOGRAPHY (CT)/INTERVEN-
TIONAL RADIOLOGY (CATH LAB)/
RADIOGRAPHY/RADIOGRAPHY AND
FLUOROSCOPY (R&F) /DENTAL/
ORTHO-PANTOMOGRAPHY (OPG)/
MAMMOGRAPHY/BONE DENSITO-
METER/MEDICAL X-RAY TUBE
AND TUBE HEAD] ..................................... 324

ANNEXURE-17 APPLICATION FOR CONSENT FOR

(3.4.3.2) SITE APPROVAL OF INTEGRATED
 FACILITY FOR RADIATION
TECHNOLOGY (IFRT) ............................... 329

ANNEXURE-18 APPLICATION FOR LAYOUT AND

(3.4.3.3) CONSTRUCTION APPROVAL FOR
INTEGRATED FACILITY FOR
RADIATION TECHNOLOGY (IFRT) ......... 333

ANNEXURE-19 APPLICATION FOR LICENCE FOR

(3.4.3.4) COMMISSIONING/OPERATION OF
INTEGRATED FACILITY FOR
RADIATION TECHNOLOGY (IFRT) ......... 338

ANNEXURE-20 APPLICATION FOR SITE AND

(3.5.1.2, 3.5.2.2, 3.8.2 LAYOUT PLAN APPROVAL OF
& 3.12.4.2) RADIOTHERAPY FACILITIES .................. 343

ANNEXURE-21 APPLICATION FOR CONSENT/NOC

(3.5.1.4, 3.5.2.4, 3.8.4 FOR PROCUREMENT/IMPORT OF
& 3.12.1.3) RADIATION GENERATING
EQUIPMENT/RADIOACTIVE
SOURCE FOR RADIATION
THERAPY FACILITY .................................. 350

ANNEXURE-22 APPLICATION FOR LICENCE/

(3.5.1.5, 3.5.2.4, AUTHORISATION/REGISTRATION
3.8.5 & 3.12.4.5) FOR COMMISSIONING AND
OPERATION OF RADIATION
THERAPY FACILITY .................................. 375

ANNEXURE-23 APPLICATION FOR SITE & LAYOUT

(3.6.2) PLAN APPROVAL AND
PROCUREMENT OF MEDICAL
X-RAY EQUIPMENT [COMPUTED
TOMOGRAPHY (CT)/INTERVEN-
TIONAL RADIOLOGY (CATH LAB)] ....... 384

ANNEXURE-24 APPLICATION FOR LICENCE FOR

(3.6.3) COMMISSIONING/OPERATION OF
MEDICAL DIAGNOSTIC X-RAY
EQUIPMENT [COMPUTED
TOMOGRAPHY (CT)/INTERVEN-
TIONAL RADIOLOGY (CATH LAB)] ....... 388
ANNEXURE-25 APPLICATION FOR CONSENT FOR
(3.7.2) PROCUREMENT OF INDUSTRIAL
GAMMA RADIOGRAPHY
EXPOSURE DEVICE(S) (IGREDs)/
INDUSTRIAL X-RAY MACHINE(S) ......... 393

ANNEXURE-26 APPLICATION FOR CONSENT FOR

(3.7.3.2) SITE LAYOUT PLAN/
CONSTRUCTION OF ENCLOSED
RADIOGRAPHY FACILITY ....................... 401

ANNEXURE-27 APPLICATION FOR SITE APPROVAL

(3.7.4) AND MOVEMENT OF IGRED/
X-RAY DEVICE FOR CONDUCTING
OPEN FIELD RADIOGRAPHY WORK ..... 407

ANNEXURE-28 APPLICATION FOR LICENCE FOR

(3.7.5) COMMISSIONING AND OPERATION
OF RADIOGRAPHY FACILITY ................. 414

ANNEXURE-29 APPLICATION FOR SITING, LAYOUT

(3.7.8.2) AND CONSTRUCTION APPROVAL
OF INDUSTRIAL ACCELERATOR
FACILITY (IAF) FOR NDT ......................... 420

ANNEXURE-30 APPLICATION FOR LICENCE FOR

(3.7.8.3) COMMISSIONING/OPERATION OF
INDUSTRIAL ACCELERATOR
FACILITY FOR (IAF) NDT ......................... 424

ANNEXURE-31 APPLICATION FOR NO OBJECTION

(3.9.2) CERTIFICATE (NOC) FOR IMPORT/
CONSENT FOR PROCUREMENT
OF GAMMA IRRADIATION
CHAMBERS (GIC) ...................................... 429

ANNEXURE-32 APPLICATION FOR AUTHORISATION

(3.9.3) FOR COMMISSIONING AND
OPERATION OF GAMMA
IRRADIATION CHAMBER (GIC) .............. 436

ANNEXURE-33a APPLICATION FOR APPROVAL OF

(3.10.1.2) SITE AND LAYOUT PLAN FOR
NUCLEAR MEDICINE FACILITY ............ 442
ANNEXURE-33b APPLICATION FOR PROCUREMENT
(3.10.1.2) OF RADIOISOTOPES FOR NUCLEAR
MEDICINE FACILITIES ............................. 446

ANNEXURE-34 APPLICATION FOR AUTHORI-

(3.10.1.4) SATION FOR COMMISSIONING
AND OPERATION OF NUCLEAR
MEDICINE FACILITY ................................ 451

ANNEXURE-35 APPLICATION FOR AUTHORI-

(3.11.1) SATION FOR FACILITIES ENGAGED
IN COMMERCIAL PRODUCTION
OF IONISING RADIATION
GAUGING DEVICES (IRGDs)/
NUCLEONIC GAUGES (NGs) .................... 457

Volume - 4

ANNEXURE-36 APPLICATION FOR AUTHORI-

(3.11.2) SATION FOR PROCUREMENT AND
USE OF THORIUM NITRATE FOR
MANUFACTURE OF CONSUMER
PRODUCT (GAS MANTLES) ..................... 462

ANNEXURE-37 APPLICATION FOR NOC FOR

(3.12.2) IMPORT /CONSENT FOR
PROCUREMENT OF SEALED
RADIATION SOURCES FOR WELL
LOGGING OPERATIONS ........................... 467

ANNEXURE-38 APPLICATION FOR AUTHORISA-

(3.12.3) TION FOR COMMISSIONING/
OPERATION OF WELL LOGGING
ACTIVITIES INVOLVING
RADIATION SOURCES .............................. 474

ANNEXURE-39 APPLICATION FOR SITE AND

(3.13.1.2) LAYOUT PLAN APPROVAL AND
PROCUREMENT OF DIAGNOSTIC
X-RAY EQUIPMENT[RADIO-
GRAPHY/RADIOGRAPHY AND
FLUROSCOPY (R&F)/ORTHO-
 PAN-TOMOGRAPHY (OPG)/
MAMMOGRAPHY/BONE
DENSITOMETER ETC.] ............................. 480

ANNEXURE-40 APPLICATION FOR REGISTRATION

(3.13.1.3) OF DIAGNOSTIC X-RAY
EQUIPMENT [RADIOGRAPHY/
RADIOGRAPHY AND FLUROSCOPY
(R&F)/DENTAL/ORTHO-PAN-TOMO-
GRAPHY (OPG)/MAMMOGRAPHY/
BONE DENSITOMETER] ........................... 485

ANNEXURE-41 APPLICATION FOR NOC FOR

(3.15.2) IMPORT/CONSENT FOR
PROCUREMENT OF IONISING
RADIATION GAUGING DEVICES
(IRGDs)/NUCLEONIC GAUGES
(NGs) CONTAINING RADIO-
ACTIVE SOURCES ..................................... 490

ANNEXURE-42 APPLICATION FOR REGISTRATION

(3.15.2) OF IONISING RADIATION
GAUGING DEVICES (IRGDS)/
NUCLEONIC GAUGE(S) (NGS)
CONTAINING RADIOACTIVE
SOURCES ..................................................... 497

ANNEXURE-43a APPLICATION FOR LAYOUT

(3.16.2.2) PLAN AND CONSTRUCTION
APPROVAL FOR RESEARCH
LABORATORIES HANDLING
RADIOISOTOPES ........................................ 502

ANNEXURE-43b APPLICATION FOR PROCUREMENT

(3.16.2.2) OF RADIOISOTOPES FOR
RESEARCH LABORATORIES ................... 505

ANNEXURE-44 APPLICATION FOR REGISTRATION

(3.16.2) OF RADIOISOTOPE RESEARCH
FACILITY (COMMISSIONING
AND OPERATION) ...................................... 509

ANNEXURE-45 APPLICATION FORMAT FOR

(3.16.3) OBTAINING REGISTRATION FOR
 BIOMEDICAL RESEARCH
STUDIES ON HUMANS ............................. 514

ANNEXURE-46 APPLICATION FOR LAYOUT PLAN

(3.17.2) APPROVAL FOR RIA/IMMUNO
RADIOMETRIC ASSAY (IRA)
LABORATORY ............................................ 518

ANNEXURE-47 APPLICATION FOR REGISTRATION

(3.17.3) OF RADIOIMMUNO ASSAY/
IMMUNO RADIOMETRIC ASSAY
(IRMA) FACILITY (COMMISSION-
ING AND OPERATION) .............................. 522

ANNEXURE-48 APPLICATION FOR PROCURE-

(3.17.3) MENT OF RADIO-ISOTOPES FOR
RADIOIMMUNO ASSAY (RIA)/
IMMUNO RADIOMETRIC ASSAY
(IRMA) FACILITY ....................................... 526

ANNEXURE-49 (FORM V) APPLICATION FOR

AUTHORISATION TO DISPOSE OF
RADIOACTIVE WASTE/DECAYED/
UNUSED SOURCES (BY SMALL
INSTALLATIONS) UNDER G.S.R.-125
ATOMIC ENERGY (SAFE DISPOSAL
OF RADIOACTIVE WASTES)
RULES, 1987-RULE 15(1) ........................... 530

ANNEXURE-50 APPLICATION FOR AUTHORISA-

TION TO TRANSFER RADIO-
ACTIVE MATERIAL TO THE
SUPPLIER/AUTHORISED WASTE
MANAGEMENT AGENCY ......................... 535

ANNEXURE-51 APPLICATION FOR APPROVAL OF

(3.18.2) SPECIAL ARRANGEMENT FOR
TRANSPORT OF RADIOACTIVE
MATERIAL ................................................... 540

ANNEXURE-52 APPLICATION FOR PACKAGE

(3.18.1) DESIGN APPROVAL FOR
TRANSPORT OF RADIOACTIVE
MATERIAL ................................................... 546
ANNEXURE-53 APPLICATION FOR NO
(3.18.1) OBJECTION CERFICATE (NOC)/
TYPE APPROVAL OF SEALED
SOURCES ..................................................... 554

ANNEXURE-54 APPLICATION FOR NO

(3.18.1) OBJECTION CERTIFICATE (NOC)
FOR IMPORT/TYPE APPROVAL
FOR TELEGAMMA THERAPY
EQUIPMENT ................................................ 560

ANNEXURE-55 APPLICATION FOR NO

(3.18.1) OBJECTION CERTIFICATE (NOC)
FOR IMPORT/TYPE APPROVAL
FOR MEDICAL LINEAR
ACCELERATOR (MLA) .............................. 570

ANNEXURE-56 APPLICATION FOR NO

(3.18.1) OBJECTION CERTIFICATE (NOC)
FOR IMPORT/TYPE APPROVAL OF
REMOTE AFTERLOADING (RAL)
BRACHYTHERAPY EQUIPMENT ............ 580

ANNEXURE-57 APPLICATION FOR NO

(3.18.1) OBJECTION CERTIFICATE (NOC)/
TYPE APPROVAL OF DIAGNOSTIC
X-RAY EQUIPMENT/RADIO-
THERAPY SIMULATOR [RADIO-
GRAPHY/RADIOGRAPHY AND
FLUOROSCOPY (R&F)/DENTAL/
ORTHO-PAN-TOMOGRAPHY (OPG)/
MAMMOGRAPHY/BONE DENSI-
TOMETER/MEDICAL X-RAY TUBE
AND TUBE HEAD] ..................................... 588

ANNEXURE-57a APPLICATION FOR NO

(3.18.1) OBJECTION CERTIFICATE (NOC)/
TYPE APPROVAL FOR RADIO-
THERAPY SIMULATOR ............................. 596

ANNEXURE-58 APPLICATION FOR TYPE APPROVAL

(3.18.1) FOR BAGGAGE INSPECTION
X-RAY SYSTEM (BIS) ................................ 605
ANNEXURE-59 APPLICATION FOR NO
(3.18.1) OBJECTION CERTIFICATE (NOC)
FOR IMPORT/CONSENT FOR
TYPE APPROVAL FOR INDUSTRIAL
GAMMA RADIOGRAPHY
EXPOSURE DEVICE (IGRED)/
SOURCE CHANGER/INDUSTRIAL
X-RAY MACHINE ....................................... 610

ANNEXURE-60 APPLICATION FOR NOC FOR

(3.18.1) IMPORT/CONSENT FOR TYPE
APPROVAL FOR IONISING
RADIATION GAUGING DEVICES
(IRGDs)/NUCLEONIC GAUGES
(NGs) ............................................................. 622

ANNEXURE-61 APPLICATION FOR TYPE

(3.18.1) APPROVAL OF CONSUMER
PRODUCTS CONTAINING
RADIOACTIVE SUBSTANCES ................. 635

ANNEXURE-62 APPLICATION FOR NO

(3.18.1) OBJECTION CERTIFICATE (NOC)
FOR IMPORT/TYPE APPROVAL
FOR MEDICAL CYCLOTRON ................... 639

ANNEXURE-63 APPLICATION FOR NO

(3.18.1) OBJECTION CERTIFICATE (NOC)
FOR IMPORT/CONSENT FOR
TYPE APPROVAL FOR INDUSTRIAL
ACCELERATOR FACILITY [(IARPF)/
(PARF < 10 MeV)/(IAF-NDT)] .................... 644

ANNEXURE-64 APPLICATION FOR NO

(3.18.1) OBJECTION (NOC) FOR IMPORT/
TYPE APPROVAL FOR GAMMA
IRRADIATION CHAMBER (GIC) .............. 650

ANNEXURE-65 APPLICATION FOR NO

(3.18.1) OBJECTION CERTIFICATE (NOC)/
TYPE APPROVAL OF MEDICAL
DIAGNOSTIC EQUIPMENT
[COMPUTED TOMOGRAPHY
 (CT)/INTERVENTIONAL
RADIOLOGY (CATH LAB)] ....................... 658

ANNEXURE-66 APPLICATION FOR CONSENT FOR

(3.16.1) PROCUREMENT OF SEALED
RADIOACTIVE SOURCES FOR
RESEARCH/CALIBRATION
PURPOSES ................................................... 666

ANNEXURE-67 APPLICATION FOR REGISTRATION

(3.16.1) OF SEALED RADIATION SOURCES
USED IN RESEARCH, CALIBRATION
OF RADIATION MONITORS AND
OTHER APPLICATIONS ............................. 673

ANNEXURE-68 APPLICATION FOR APPROVAL OF

(3.18.3) RADIOLOGICAL SAFETY
OFFICER (RSO) ........................................... 678

BIBLIOGRAPHY ....................................................................... Bi

LIST OF PARTICIPANTS ....................................................................... Li

WORKING GROUP ....................................................................... Li

ADVISORY COMMITTEE FOR PREPARATION OF CODES,

GUIDES AND MANUALS ON GOVERNMENTAL
ORGANISATION FOR REGULATION OF NUCLEAR AND
RADIATION FACILITIES (ACCGORN) ............................... Liii

PROVISIONAL LIST OF CODES, GUIDES AND MANUALS

FOR REGULATION OF NUCLEAR AND RADIATION
FACILITIES ............................................................... Pi
VOLUME - 2
 APPENDIX-1
(Refer section 2.2)

INDUSTRIAL SAFETY

In the department of atomic energy (DAE) units AERB is responsible for enforcement
of the Factories Act, 1948 and the Atomic Energy (Factories) Rules, 1996. Competent
persons and safety officers are required to be appointed to carry out duties as mentioned
in the above statutes.
For fire safety both manpower and fire fighting equipment are required to be provided
as per AERB safety standard for ‘Fire Protection Systems of Nuclear Facilities’ [AERB/
NF/SS/FPS (Rev. 1)]. All fire fighting equipment should be inspected and tested
periodically as stipulated in the standard.
Pressure vessels and vacuum systems should be periodically inspected and tested as
specified in the Atomic Energy (Factories) Rules, 1996 and should carry necessary
certification from a competent person. Handling and storage of gas cylinders should
be as per gas cylinder rules. All hoists, lifts and lifting tackles should be subjected to
periodic inspection and testing and should be certified by a competent person. All
moving machinery should be provided with protective guard. Periodic calibration of
monitoring instruments and preventive maintenance of all the machinery and equipment
should be done.
Noise in the work areas should be monitored and appropriate remedial measures/
personal protective equipment (PPE) should be used. Appropriate lighting should be
provided in the working areas and illumination should be measured. For noise and
illumination, requirement as specified in the Atomic Energy (Factories) Rules, 1996
should be adhered to.
First aid provision should be available in the facility along with appropriate staff trained
in first aid. Pre-employment medical examination and periodic medical examination
should be carried out and the periodicity should be as specified in the Atomic Energy
(Factories) Rules, 1996.
Pipelines should be colour coded as per Indian standard: 2379-1963 and Indian
Standard: 5-1978. Electrical conduit panels should be colour coded as per Indian
Standard: 375-1951 and Indian Standard: 5-1978. All construction should conform to
National Building Code of bureau of indian standards (BIS) and relevant AERB
documents. All ladders should be maintained as per the requirements mentioned in the
Atomic Energy (Factories) Rules, 1996.
Material safety data sheet should be available for all hazardous chemicals handling
and necessary personal protective equipment conforming to relevant Indian Standards
should be provided to the workers exposed to hazards. Hand tools and portable power

87
tools should conform to the relevant BIS standards and should be used as per the
requirements specified in the Atomic Energy (Factories) Rules, 1996.
Work environment and the neighbourhood should be monitored for physical, chemical
and biological agents and see that the limits specified by the Acts and Competent
Authority are not exceeded at any time.

88
 (APPENDICES - 2A-2F PERTAIN TO GRAPF FACILITY)

APPENDIX-2A
(Refer section 3.2.1.2)

FORMAT OF SITE ASSESSMENT REPORT FOR GAMMA

RADIATION PROCESSING FACILITY (GRAPF)

Geological and Geotechnical Investigations

1. Site investigations for Gamma Irradiators are necessary to determine the

geotechnical characteristics of the site that affect the design, performance
and safety of the irradiators. The investigations should produce the information
needed to define the overall site geology to a degree that is necessary for an
understanding of the subsurface conditions in order to ensure stability against
natural hazards like earthquake, flood etc.
2. Site investigations should also provide information needed to define ground
water conditions as well as the geotechnical parameters needed for analysis
and design of foundations. These include parameters to evaluate the subsurface
characteristics for safe engineering of irradiators, such as bearing capacity
of foundation material, lateral earth pressure, the stability of cuts and slopes
in rock, the effects of earthquake induced motions transmitted through
underlying deposits on the response of soils and structure (including the
potential for inducing liquefaction in soils) and also those needed to estimate
the expected settlement of the structure.
3. Requirements of geotechnical investigations depend on the site specific
conditions. However, the following investigations are the minimum, which
should be carried out for the evaluation of parameters required for safe design:
(a) Field Work
(i) Drilling of bore holes, excavation of trial pits
(ii) Collection of disturbed/undisturbed soil and water samples
(iii) Standard penetration tests
(iv) Plate load tests
(v) Electrical resistivity tests
(vi) Permeability tests
(b) Laboratory Tests on Soil Samples
(i) Grain size analysis (coarse and fine)

89
 (ii) Consistency limit test
(iii) Specific gravity of soil
(iv) Proctor density test
(v) Permeability test
(vi) Consolidation test
(vii) Modulus of elasticity and poisons ratio
(viii) Unconfined/confined compression test
(ix) Direct shear test (consolidated drained)
(x) Chemical tests on soil
(c) Laboratory Tests on Rock Samples
(i) Petrographic study
(ii) Porosity
(iii) Unconfined/confined compression test
(iv) Modulus of elasticity and poisons ratio
(d) Test on Ground Water Samples
(i) Chemical analysis of ground water sample
4. Following requisites should be met in connection with geotechnical
investigations:
(i) Prior to commencement of geotechnical investigation, a
comprehensive plan of the work should be chalked out. Geological
status of the site should be examined based on available information.
Additional investigation may be required if site specific conditions
warranted so for the safety of the plant.
(ii) Minimum depth of bore holes should be three times the larger
dimension of the footing.
(iii) Number of bore holes should be such that subsurface profile of the
plant area can be drawn with reasonable certainty in any direction.
At least four data points should be available, in any direction, for
plotting of sub surface profile.
(iv) Geological mapping of the foundation pit should be carried out after
completion of excavation.
(v) Appropriate rectification/stabilisation measures shall be adopted if
it is found necessary after excavation.

90
4.1 Reports on Geotechnical Investigation
The geotechnical report should contain the following details:
(i) Geological status of the site based on available information
(ii) Details of bore logs and trial pit logs
(iii) Permeability test results
(iv) Ground water observations
(v) Results of soil and rock tests
(vi) Chemical test results of water
(vii) Subsurface profiles
(viii) Electrical resistivity logging
(ix) Petrographic study results
(x) Evaluation of foundation design parameters

91
 APPENDIX-2B
(Refer section 3.2.1.3)

FORMAT OF THE PRELIMINARY SAFETY ANALYSIS REPORT FOR

GAMMA RADIATION PROCESSING FACILITY (GRAPF)

[PSAR should be submitted to AERB in this format, duly signed by

Head of the organisation (employer)]

A. INTRODUCTORY INFORMATION

1. Name and address of institution :

(with e-mail and fax)
2. Name and address of
Gamma radiation processing plant :
(GRAPF) (with e-mail and fax)
3. Name and address of the
designer(s) of GRAPF :
(with e-mail and fax)
4. Name and address of the :
manufacturer of GRAPF
(with e-mail and fax)
5. Category of GRAPF :
6. Name of radioactive source :
7. Maximum design strength of source : ————— PBq (——— kCi)
8. Address of the supplier of the source :
(with e-mail and fax)
9. Purpose of GRAPF :

B. TECHNICAL DESCRIPTION OF THE GAMMA

RADIATION PROCESSING FACILITY (GRAPF)

1. Brief description of the facility

2. Design details : (design principles, defence in depth concept, redundancy.
independence and diversity in the design, built-in-safety features provided in
the design, statement declaring compliance with the AERB Safety Standard

92
 titled ‘Land-Based Stationary Gamma Irradiators’ [AERB/RF-IRRAD/SS-6
(Rev.1); 2007].
3. Site of installation of GRAPF: Geotechnical and geological information, field
investigations, water table, weather, soil profile, laboratory investigations,
allowable bearing pressure/safe bearing capacity, chemical analyses of water
and soil
Site lay out, documentary evidence of the ownership of the site, regulatory
Consent issued by AERB for site approval
- Structural details - type and depth of foundation, seismic requirements
and precautions against flooding
- Buildings and residential complexes, occupancy, etc. within 50 m
radius of the source location; give layout and height of the adjacent
tallest building in the vicinity of 100 m)
- Access roads to the facility: road strength and width to carry transport
flasks (culvert/bridge, if any, on the way - specify)
- Any additional information
Biological shield
- Sketch giving details of shielding wall surrounding the source, wall
thickness, labyrinth access, openings, voids, reinforcements,
embedment etc. in the biological shield.
- Shield material, density, quality assurance during construction
- Maximum & minimum shield thickness, roof thickness
- Dose rate profiles anticipated at various locations: (Maximum and
minimum values). Indicate them on a sketch of the facility - to be
stationed for work or otherwise.
- Maximum dose rate anticipated
Locations : (Indicate also in a sketch)
4. Safety Systems/Interlocks
4.1 Water Pool
- Detailed sketch or drawing of water pool for source storage showing
dimensions, water proofing, lining details, penetrations, piping,
fittings, embedment, locations of level measuring devices, inlet-outlet
water piping,
- Water control dimensions, volume, maximum, minimum water levels,
normal level and abnormal levels.

93
 - Overhead water storage tank details, provision of emergency water
discharge into pool, provision of overflow/ drainage of water from
the pool to any municipal sewerage lines.
- Municipal water supply quality - TSD, TSS, hardness and
conductivity
- Rate of water supply in emergency
- Quantity of water maintained in pool, conductivity maximum/
minimum, method of assuring water quality
- Method of assuring water levels
- Leakage from pool - prevention and assessment
- Normal evaporation water losses from pool (with and without
ventilation) related to humidity and temperature
- System to prevent water flooding in the cell
- Method of cleaning water pool
- Pool grill cover strength - prevention of accidental fall into the pool
- during normal times, during source loading operations
- Pool bottom surface plan - loading conditions, anchoring of source
rack, provision for transport container, intermediate source storage,
if any.
- Corrosion - intermetallic/galvanic, specification of metals coming
in contact with pool water prevention thereof.
- Maximum water height above source rack during normal operation
and expected radiation profiles on the pool surface, both at normal
and abnormal water levels.
- Underwater lights, location, voltage, use, prevention of shocks and
electrocution.
- Prevention of accidental fall of person and material into the pool
- Prevention of syphoning action in pool
- Prevention of accidental entry into the cell when the water level in
the pool is low and when the source is exposed or in storage position.
- DM water plant capacity and type (anion, cation, mixed bed etc.)
4.2 Source Drive System
- Details of mechanical arrangement (include drawing) source raise/
lower loop. Anchoring and supports of source rack, source locking
in the rack, prevention of accidental fall of sources.
- Maximum/minimum hydraulic pressure, cylinder type and their
specifications
- Gravity/accidental fall of rack into the pool

94
 - Source getting stuck in the exposed position - possibilities of remedial
action
- Tension adjustment (and monitoring) in the ropes
- Source movement control - limits/ overshoot
- Protection to source rack from product/carrier/conveyor interference
- Accidental fall of carrier, product, product box into the pool -
protection thereof
- Material of construction of - source rack, wires, fittings, etc.
4.3 Source Raise Conditions
- Information should include - protection against human access to the
cell when the source is in raised position, mechanical, electrical,
hydraulic, radiation interlocks, trespass control through product entry
door.
- Interference to interlocks and source safety and protection against
exposure to radiation
- Power failure and protection against accidental entry
- Cautions, display, alarm against entry into the cell
Source operation disable situation:
Describe point by point conditions under which the source cannot
be raised from safe storage provisions. Emergency termination of
source raise operations
Automatic source lowering situations:
Describe point by point situations under which the exposed source
will move to storage position. Methods to achieve fail safe situation
and monitoring thereof
Preconditions to raise source:
List the preconditions to be satisfied before the source can raised
4.4 Ventilation System
- Volume of cell including and excluding labyrinth, ventilation rate
provided, anticipated minimum air changes in the cell
- Location and routing of ventilated ducts, fans, duct size, etc. (give
sketch)
- Methods of monitoring ventilation and action on ventilation failure
- Location of ventilation exhaust and the height above the cell roof.
Prevention of water flooding through ventilation ducts from roof
(sketch)

95
 - Ozone concentration (maximum) anticipated in the cell with
ventilation on and off. Time duration in minutes for safe concentration
of ozone in the cell (0.1ppm) after the exhaust is switched off.
- Prevention of entry to the cell when unsafe limit of ozone
concentration exists
- Details of interlocks to retract the source to safe storage position in
case of ventilation failure
- Provision for standby ventilation exhaust fans, if any
- Electric power failure rate. The number of days the source is likely
to remain in the pool without exhaust and ventilation.
4.5 Fire Detection System
- Detection methods of excessive temperature rise, smoke, fire, and
interlock if any with the source movement. Type of detectors used
and their sensitivity, location of detectors.
- Validity certification for detectors
- Direction escape route for fire - fire fighting system, fire hydrants,
extinguishers, dry risers, etc.
4.6 Control System General
- Give control system description in brief
- Voltage and currents employed, emergency power standby power,
battery backup if any,
- Control logic and flow of command
- Interlock systems for fail-safe operation
4.7 Audio-visual Alarms/Anunciators
- Describe the list of audio-visual alarms provided, their location,
purpose and effectiveness - against exposure to radiation, fire, smoke,
toxic gases, etc.
4.8 Power Failure and Auxiliary Power
- Provisions made when power failure occurs, status of safety systems
and source position indicators
4.9 Access Control
- Provisions made at personnel entry door and product entry door
5. Design Basis Accident Analysis and Safety Provisions
Abnormal events mentioned below shall be analysed and methods for
achieving safety under these events shall be described.

96
 (a) Accidental exposures
(b) Breaking of source hoist cable
(c) Fraying of source hoist cable in side the cell roof tube
(d) Source frame stuck in rest position due to
(i) jamming of source raise wire rope in roof tube assembly
(ii) jamming of source frame on guide wire ropes
(e) Failure of mooring of guide wire ropes of source frame
(f) Failure of PAD interlocks
(g) Fire in the irradiation cell
(h) Failure of ventilation system
(i) Damage to the sources
(j) Contamination of pool water
(k) Leakage of water from pool
(l) Earthquake at the irradiator site
(m) Flooding of irradiator cell with water
(n) Breakage of pool lining
(o) Fall of person in the water pool
(p) Product carrier interfering with source frame; dislodging of source
in carriers and coming out of shield with it.
The designer/manufacturer shall carry out such safety analysis to demonstrate
means provided to prevent and handle above situations safely .
6. Radiation Source Details
(i) Address of supplier :
(ii) Type and nature of radioactive source :
(iii) Chemical form :
(iv) Physical form :
(v) Source pencil (ISU) : length, diameter,
assembly drawing and identification welding method etc.
7. Provisions including Adequate Financial Arrangement for Safe Disposal of
Spent/Disused Sources
8. Decommissioning of GRAPF
- Procedure to be followed when decision is made to close down the
facility permanently.

97
 APPPENDIX-2C
(Refer section 3.2.1.4)

FORMAT FOR THE ACCEPTANCE TEST REPORT TO VERIFY

FUNCTIONAL PERFORMANCE OF SAFETY
SYSTEMS/INTERLOCKS FOR GRAPF

(All the safety systems/sensors/signals/interlocks should be tested at least 15-20

times, with source rack in RAISED and DOWN position. Records in the
format prescribed herewith shall be maintained separately each time)

1. SAFETY SYSTEMS/INTERLOCKS

S. Safety Test Expected response of Observed

No. system/ conducted control system response
Interlock of
control
system
1. Pressure plate Pressed or 1. Emergency alarm should sound,
removed message to be displayed on the
monitor and a hard copy to be
obtained
2. Source, if exposed should lower and
the conveyor should stop, if ON.
3. Search should get cancelled
4. Search can not be started or
conducted if the emergency persists
2. Trip wire Pulled or 1. Emergency alarm should sound,
removed message to be displayed on the
monitor and a hard copy to be
obtained
2. Source, if exposed should lower and
the conveyor should stop, if ON.
3. Search should get cancelled
4. Search can not be started or
conducted if the emergency persists
3. Emergency Pressed 1. Emergency alarm should sound,
push buttons at message to be displayed on the
different monitor and a hard copy to be
locations (to be obtained
tested 2. Source, if exposed should lower and
separately) the conveyor should stop, if ON.
3. Search should get cancelled
4. Search can not be started or
conducted, if the emergency persists

98
 1. SAFETY SYSTEMS/INTERLOCKS (CONTD.)

S. Safety Test Expected response of Observed

No. system/ conducted control system response
Interlock of
control
system
4. Service keyes Operated to 1. Emergency alarm should sound,
at different select message to be displayed on the
locations(to be maintenance monitor and a hard copy to be
tested position obtained
separately) 2. Source, if exposed should lower and
the conveyor should stop, if ON.
3. Search should get cancelled
4. Search can not be started or
conducted if the emergency persists
5. Source raise Simulated by 1. Emergency alarm should sound,
wire rope actuating the message to be displayed on the
tension limit switches monitor and a hard copy to be
which sense obtained
the rope 2. Source, if exposed should lower and
stretch and the conveyor should stop, if ON.
break 3. Search should get cancelled
condition 4. Search can not be started or
conducted if the emergency persists
6. Cell exhaust air Simulated the 1. Emergency alarm should sound,
flow condition by message to be displayed on the
stopping the monitor and a hard copy to be
exhaust fan obtained
2. Source, if exposed should lower and
the conveyor should stop, if ON.
3. Search can not be started or
conducted if the emergency persists
7. Hydraulic oil Simulated by 1. Message to be displayed on the
level low manually monitor and a hard copy to be
actuating the obtained
oil level 2. Emergency alarm should sound
switch 3. Source if exposed should lower and
the conveyor should stop, if ON.
4. Search can not be started or
conducted if the emergency persists
5. Hydraulic motor should stop.

99
 1. SAFETY SYSTEMS/INTERLOCKS (CONTD.)

S. Safety Test Expected response of Observed

No. system/ conducted control system response
Interlock of
control
system
8. Clutch Conveyor 1. Clutch should disengage stopping
operated overload the conveyor
condition 2. Source, if exposed should lower
created by 3. Message to be displayed on the
simulation monitor and a hard copy to be
obtained
4. Search can not be started or
conducted if the emergency persists
9. A.C. Supply Simulated by 1. Emergency alarm should sound,
under voltage lowering the message to be displayed on the
supply voltage monitor and a hard copy to be
using a variac obtained
or by any 2. Source, if exposed should lower and
other means. the conveyor should stop, if ON.
3. Search can not be started or
conducted if the emergency persists
10. A.C. Supply Simulated by 1. Emergency alarm should sound,
over voltage increasing the message to be displayed on the
supply voltage monitor and a hard copy to be
using a variac obtained
or by any 2. Source, if exposed should lower and
other means the conveyor should stop, if ON.
3. Search can not be started or
conducted if the emergency persists
11. DC Supply Simulated by 1. Emergency alarm should sound,
under voltage switching off message to be displayed on the
the DC voltage monitor and a hard copy to be
obtained
2. Source, if exposed should lower and
the conveyor should stop, if ON.
3. Search can not be started or
conducted if the emergency persists
12. Pool water Simulated by 1. Audio alarm and visual indication
contaminated bringing a test by contamination monitor
r a d i o a c t i v e 2. Emergency alarm should sound,
source near the message to be displayed on the
detector of the monitor and a hard copy to be
contamination obtained
monitor

100
 1. SAFETY SYSTEMS/INTERLOCKS (CONTD.)

S. Safety Test Expected response of Observed

No. system/ conducted control system response
Interlock of
control
system
12. 3. Source, if exposed should lower and
(Con- the conveyor should stop, if ON.
td.) 4. Search should get cancelled
5. Search can not be started or
conducted if the emergency persists
6. DM water pump should stop to
prevent circulation of contaminated
water
13 Motive power Simulated by 1. Battery back up supply to PLC
failure switching off through UPS
the main 2. Source position indicators and
power supply emergency to be displayed
3. Source, if exposed should lower by
gravity and the conveyor should
stop, if ON.
14 PLC failure Simulated by 1. Source, if exposed should lower by
switching off gravity and the conveyor should
PLC supply stop, if ON.
2. Prevents source raising operations
15 Product box Simulated by 1. Source, if exposed should lower and
jammed jamming the conveyor should stop, if ON.
product boxes 2. Prevents source raising operations
16 Seismic Simulated by 1. Source, if exposed should lower and
detector creating the conveyor should stop, if ON
excess 2. Prevents source raising operations
vibrations

Tests Conducted by Tests Approved by

(i) Name Name

Designation Designation

(ii) Name Name

Designation Designation

(Facility-In-Charge/RSO/Operator
of Radiation Processing Facility)

101
 2. AREA/ZONE MONITORS

S. Area Test Expected response of Observed

No. monitors conducted control system response
of
radiation
monitors
1. Area monitor Simulated by 1. Audio alarm and visual indication
installed in bringing a test by area monitor.
control room: radioactive 2. Radiation plunger should fall in the
radiation source near groove provided on latch bar so that
interlock the detector door can not be opened
(Radiation located inside 3. Emergency alarm should sound
present in the the cell. 4. Message to be displayed on the
cell when the monitor and a hard copy to be
source is in obtained
shield) 5. Search should get cancelled
6. Search can not be started or
conducted if the emergency persists
2. Area monitor Simulated by 1. Audio alarm and visual indication
installed in bringing a test by area monitor
DM plant r a d i o a c t i v e 2. Emergency alarm should sound
source near the 3. Message to be displayed on the
detector of the monitor and a hard copy to be
area monitor obtained
4. Search should get cancelled
5. Search can not be started or
conducted if the emergency persists
6. DM water pump should stop to
prevent circulation of contaminated
water
3. Area monitor Simulated by 1. Audio alarm and visual indication
installed at bringing a test by area monitor
product exit r a d i o a c t i v e 2. Emergency alarm should sound
door. source near the 3. Message to be displayed on the
detector of the monitor and a hard copy to be
area monitor obtained
4. Source, if exposed should lower and
the conveyor should stop, if ON.
5. Search should get cancelled
6. Search can not be started or
conducted if the emergency persists

102
Tests Conducted by Tests Approved by

(i) Name Name

Designation Designation

(ii) Name Name

Designation Designation

(Facility-In-Charge/RSO/Operator
of Radiation Processing Facility)

3. EMERGENCY WATER LEVEL SENSOR

S. Interlock Test Expected response of Observed

No. conducted control system response
of
control
system
1. Emergency Release to 1. Emergency alarm should sound,
float switch simulate water message to be displayed on the
WL3 level too low monitor and a hard copy to be
condition (in obtained
source raised 2. Source, if exposed should lower and
condition) the conveyor should stop, if ON.
3. Emergency solenoid valve should
open and should permit municipal
water to flow into water pool till
normal level is reached
4. Door lock solenoid should drop into
latch bar and cell door cannot be
opened
5. Search should get cancelled
2.
Emergency Release to 1. Emergency alarm should sound,
float switch simulate water message to be displayed on the
(Con-
WL3 level too low monitor and a hard copy to be
td.)
condition (in obtained.
source 2. Area Monitor installed in control
lowered room should give audio alarm and
condition) visual indication
3. Search completion procedure
should be inhibited
4. Source cannot be raised

103
 3. EMERGENCY WATER LEVEL SENSOR (CONTD.)

S. Interlock Test Expected response of Observed

No. conducted control system response
of
control
system
2. 5. Emergency solenoid valve should
(Con- open and should permit municipal
td.) water to flow into water pool till
normal level is reached
6. Door lock solenoid should drop into
latch bar and cell door cannot be
opened

Tests Conducted by Tests Approved by

(i) Name Name

Designation Designation

(ii) Name Name

Designation Designation

(Facility-In-Charge/RSO/Operator
of Radiation Processing Facility)

4. HEAT DETECTOR AND FIRE FIGHTING SYSTEM

S. Interlock Test Expected response of Observed

No. conducted control system response
of
control
system
1. Heat detector Create the 1. Message to be displayed on the
high monitor and a hard copy to be
temperature obtained
condition by 2. Emergency alarm and fire in cell
using a hot air alarm should sound
blower 3. Source, if exposed should lower and
the conveyor should stop, if ON.
4. Search should get cancelled
5. Search can not be started or
conducted if the emergency persists

104
 4. HEAT DETECTOR AND FIRE FIGHTING SYSTEM (CONTD.)

S. Interlock Test Expected response of Observed

No. conducted control system response
of
control
system
1. 6. Exhaust fan should stop to prevent
(Con- air circulation
td.) 7. Control system to give message for
operating fire fighting system
2. Smoke detector Create smoke 1. Message to be displayed on the
by appropriate monitor and a hard copy to be
means obtained
2. Emergency alarm and fire in cell
alarm should sound
3. Source, if exposed should lower and
the conveyor should stop, if ON.
4. Search should get cancelled
5. Search can not be started or
conducted if the emergency persists
6. Exhaust fan should stop to prevent
air circulation
7. Control system to give message for
operating fighting system

Tests Conducted by Tests Approved by

(i) Name Name

Designation Designation

(ii) Name Name

Designation Designation

(Facility-In-Charge/RSO/Operator
of Radiation Processing Facility)

105
 5 (i) SEARCH OPERATION - 1
(Hydraulic pump is ON and search not performed)

S. Description/ Test Expected response of Observed

No. Interlock conducted control system response
of
control
system
1. Source raise Pressed Source should not come up
PB (Mode of
box transfer-
auto)
2. Source raise Pressed Source should not come up
PB (Mode of
box transfer-
manual)

Tests Conducted by Tests Approved by

(i) Name Name

Designation Designation

(ii) Name Name

Designation Designation

(Facility-In-Charge/RSO/Operator
of Radiation Processing Facility)

5 (ii) SEARCH OPERATION - 2

(Improper Search Sequence)

S. Interlock Test Expected response of Observed

No. conducted control system response
of
control
system
1. Search start Pressed 1. Search start lamp to glow
Push Button 2. Search alarm should sound
(PB) 3. Message should be displayed on the
monitor and a hard copy to be
obtained

106
 5 (ii) SEARCH OPERATION - 2 (CONTD.)
(Improper Search Sequence)

S. Discription/ Test Expected response of Observed

No. interlock conducted control system response
of
control
system
2. Search PB 1 Pressed 1. Search start lamp to glow
2. Search alarm should sound, message
should be displayed on the monitor
and a hard copy to be obtained
3. Search PB 3 Pressed 1. Search procedure and search audio
instead of alarm should cancel. Search start
search PB2 lamp should become OFF.
2. Message should be displayed on the
monitor and a hard copy to be
obtained
4. Source raise Pressed 1. Source should not come up.
PB 2. Message should be displayed on the
monitor and a hard copy to be
obtained

Note : The above operations should be performed with different combinations of search push buttons.

Tests Conducted by Tests Approved by

(i) Name Name

Designation Designation

(ii) Name Name

Designation Designation

(Facility-In-Charge/RSO/Operator
of Radiation Processing Facility)

107
 6. POOL WATER LEVEL INTERLOCK CHECKS***

S. Condition Water Water Water Water Water Audio /

No. pump Solenoid 1 Solenoid 2 Solenoid 3 Solenoid 4 Visual
On / Off Open / Open / Open / Open / alarm
Close Close Close Close status
1. Pool water level
‘Normal’
2. Pool water level
below 150 mm
(Float switch 1
dropped)
3. Pool water level
below 300 mm
(Float switch 2
dropped)
4. Pool water level
below 450 mm
(Emergency)(Float
switch 1, 2 and 3
dropped)
5. DM water level in
buffer tank below
float level (Float
switch dropped)
6. Pool water
conductivity > Set
value

*** Indicate the operational status of water pump/solenoid under different conditions. In case of
more than four solenoids, operational status of the same may be indicated.

Tests Conducted by Tests Approved by

(i) Name Name

Designation Designation

(ii) Name Name

Designation Designation

(Facility-In-Charge/RSO/Operator
of Radiation Processing Facility)

108
 APPENDIX-2D
(Refer section 3.2.1.5)

FORMAT OF THE FINAL SAFETY ANALYSIS REPORT FOR

GAMMA RADIATION PROCESSING FACILITY (GRAPF)

[FSAR should be submitted to AERB in this format, duly signed by

Head of the organisation (employer) along with application for
licence for commissioning operation of I.B.S. Gamma Radiation
Processing Facility (GRAPF)]

A. GENERAL INFORMATION

1. Name and address of institution :

(with e-mail and Fax)
2. Name and address of
Gamma radiation processing plant :
(GRAPF) (with e-mail and Fax)
3. Name and address of the
designer(s) of GRAPF :
(with e-mail and Fax)
4. Name and address of the :
manufacturer of GRAPF
(with e-mail and Fax)
5. Category of GRAPF :
6. Name of radioactive source :
7. Maximum design strength of source : ————— PBq (——— kCi)
8. Address of the supplier of the source :
(with e-mail and Fax)
9. Purpose of GRAPF :

B. TECHNICAL DESCRIPTION OF THE GAMMA

RADIATION PROCESSING FACILITY (GRAPF)

1. Brief Description of the Facility

2. Design details : (design principles, defence-in-depth concept, redundancy.
independence and diversity in the design, built-in-safety features provided in

109
 the design, statement declaring compliance with the AERB Safety Standard
titled ‘Land-Based Stationary Gamma Irradiators’ [AERB/RF-IRRAD/SS-6
(Rev.1); 2007].
3. Site of installation of GRAPF : Geotechnical and geological information,
field investigations, water table, weather, soil profile, laboratory
investigations, allowable bearing pressure/safe bearing capacity, chemical
analyses of water and soil
Site lay out, documentary evidence of the ownership of the site, regulatory
Consent issued by AERB for site approval
- Structural details - type and depth of foundation, seismic requirements
and precautions against flooding
- Buildings and residential complexes, occupancy, etc. within 50 m
radius of the source location; give layout and height of the adjacent
tallest building in the vicinity of 100 m)
- Access roads to the facility : road strength and width to carry transport
flasks (culvert/bridge, if any, on the way - specify)
- Any additional information
Biological shield
- Sketch giving details of shielding wall surrounding the source, wall
thickness, labyrinth access, openings, voids, reinforcements,
embedment etc. in the biological shield
- Shield material, density, quality assurance during construction
- Maximum and minimum shield thickness, roof thickness
- Dose rate profiles anticipated at various locations : (Maximum and
minimum values). Indicate them on a sketch of the facility - control
room, roof, access doors, openings and where personnel are expected
to be stationed for work or otherwise.
- Maximum dose rate anticipated
Locations : (Indicate also in a sketch)
4. Safety Systems/Interlocks
4.1 Water Pool
- Detailed sketch or drawing of water pool for source storage showing
dimensions, water proofing, lining details, penetrations, piping,
fittings, embedment, locations of level measuring devices, inlet-outlet
water piping,
- Water control dimensions, volume, maximum, minimum water levels,
normal level and abnormal levels.

110
 - Overhead water storage tank details, provision of emergency water
discharge into pool, provision of overflow/ drainage of water from
the pool to any municipal sewerage lines.
- Municipal water supply quality - TSD, TSS, hardness and
conductivity
- Rate of water supply in emergency
- Quantity of water maintained in pool, conductivity maximum/
minimum, method of assuring water quality
- Method of assuring water levels
- Leakage from pool - prevention and assessment
- Normal evaporation water losses from pool (with and without
ventilation) related to humidity and temperature
- System to prevent water flooding in the cell
- Method of cleaning water pool
- Pool grill cover strength - prevention of accidental fall into the pool
- during normal times, during source loading operations
- Pool bottom surface plan - loading conditions, anchoring of source
rack, provision for transport container, intermediate source storage,
if any.
- Corrosion - intermetallic/galvanic, specification of metals coming
in contact with pool water prevention thereof.
- Maximum water height above source rack during normal operation
and expected radiation profiles on the pool surface, both at normal
and abnormal water levels.
- Underwater lights, location, voltage, use, prevention of shocks and
electrocution.
- Prevention of syphoning action in pool
- Prevention of accidental entry into the cell when the water level in
the pool is low and when the source is exposed or in storage position.
- DM water plant capacity and type (anion, cation, mixed bed etc.)
4.2 Source Drive System
- Details of mechanical arrangement (include drawing) source raise/
lower loop. Anchoring and supports of source rack, source locking
in the rack, prevention of accidental fall of sources.
- Maximum/minimum hydraulic pressure, cylinder type and their
specifications

111
 - Gravity/accidental fall of rack into the pool
- Source getting stuck in the exposed position - possibilities of remedial
action
- Tension adjustment (and monitoring) in the ropes
- Source movement control - limits/overshoot
- Protection to source rack from product/carrier/conveyor interference
- Accidental fall of carrier, product, product box into the pool -
protection thereof
- Material of construction of - source rack, wires, fittings, etc.
4.3 Source Raise Conditions
- Information should include - protection against human access to the
cell when the source is in raised position, mechanical, electrical,
hydraulic, radiation interlocks, trespass control through product entry
door.
- Interference to interlocks and source safety and protection against
exposure to radiation
- Power failure and protection against accidental entry
- Cautions, display, alarm against entry into the cell
Source operation disable situation :
Describe point by point conditions under which the source cannot
be raised from safe storage position. Emergency termination of source
raise operations
Automatic source lowering situations :
Describe point by point situations under which the exposed source
will move to storage position. Methods to achieve fail safe situation
and monitoring thereof
Preconditions to raise source :
List the preconditions to be satisfied before the source can raised
4.4 Ventilation System
- Volume of cell including and excluding labyrinth, ventilation rate
provided, anticipated minimum air changes in the cell
- Location and routing of ventilated ducts, fans, duct size, etc. (give
sketch)
- Methods of monitoring ventilation and action on ventilation failure

112
 - Location of ventilation exhaust and the height above the cell roof.
Prevention of water flooding through ventilation ducts from roof
(sketch)
- Ozone concentration (maximum) anticipated in the cell with
ventilation on and off. Time duration in minutes for safe concentration
of ozone in the cell (0.1ppm) after the exhaust is switched off.
- Prevention of entry to the cell when unsafe limit of ozone
concentration exists
- Details of interlocks to retract the source to safe storage position in
case of ventilation failure
- Provision for standby ventilation exhaust fans, if any
- Electric power failure rate. The number of days the source is likely
to remain in the pool without exhaust and ventilation.
4.5 Fire Detection System
- Detection methods of excessive temperature rise, smoke, fire, and
interlock if any with the source movement. Type of detectors used
and their sensitivity, location of detectors.
- Validity certification for detectors
- Direction escape route for fire - fire fighting system, fire hydrants,
extinguishers, dry risers, etc.
4.6 Control System General
- Give control system description in brief
- Voltage and currents employed, emergency power standby power,
battery backup if any,
- Control logic and flow of command
- Interlock systems for fail-safe operation
4.7 Audio-visual Alarms/Anunciators
- Describe the list of audio-visual alarms provided, their location,
purpose and effectiveness - against exposure to radiation, fire, smoke,
toxic gases, etc.
4.8 Power Failure and Auxiliary Power
- Provisions made when power failure occurs, status of safety systems
and source position indicators
4.9 Access Control
- Provisions made at personnel entry door and product entry door

113
5. Design Basis Accident Analysis
Abnormal events mentioned below shall be analysed and methods for
achieving safety under these events shall be described.
(a) Accidental exposures
(b) Breaking of source hoist cable
(c) Fraying of source hoist cable in side the cell roof tube
(d) Source frame stuck in rest position due to
(i) jamming of source raise wire rope in roof tube assembly
(ii) jaming of source frame on guide wire ropes
(e) Failure of mooring of guide wire ropes of source frame
(f) Failure of PAD interlocks
(g) Fire in the irradiation cell
(h) Failure of ventilation system
(i) Damage to the sources
(j) Contamination of pool water
(k) Leakage of water from pool
(l) Earthquake at the irradiator site
(m) Flooding of irradiator cell with water
The designer/manufacturer shall carry out such safety analysis to demonstrate
means provided to prevent and handle above situations safely.
6. Design Basis Accident Analysis and Safety Povisions
(a) Breaking of source raised wire rope
(b) Fraying of source raised wire ropes
(c) Source frame stuck in rest position due to,
(i) jamming of source raise wire rope in roof tube assembly
(ii) jaming of source frame on guide wire ropes
(d) Failure of personal entry door interlocks
(e) Fire in the cell
(f) Contamination of pool water
(g) Breakage of pool lining
(h) Flooding of the cell
(i) Fall of person in the water pool
(j) Product carrier interfering with source frame; dislodging of source
in carriers and coming out of shield with it.

114
7. Acceptance Test Reports by Applicant
a. Start-up sequence : Performance test
b. Shut down sequence : Performance test
c. Performance tests : Motors :
Pumps :
d. Performance of : Tripwire and other automatic
interlocks source safe or fail safe systems
e. High pressure lines : Test results - pressure gauge, valves,
temperature cut off, etc.
f. Electrical systems :
earthing
g. Leakage of pool water : (10 days: mean value mm/day)
evaporation test (with
switch off ventilation)
h. Ventilation : Air changes :
i. Dummy source load/ :
unload operations
j. Source raise/lower operational reliability (50 operations) without
failure or interference
k. System operations for one day without failure
m. Location and functions of all radiation monitors
n. Proof tests for hoists and handling equipment
8. Radiation Source Details
a. Address of supplier :
b. Type and nature of radioactive source :
c. Chemical form :
d. Physical form :
e. Source encapsulation details :
f. Source pencil (ISU) : (length, diameter,
assembly drawing welding method, etc.)
and identification
g. Total number of ISU’s :

115
 h. Quantity of activity : —— PBq ( ——— kCi)
(total) per ISU
i. Total activity : ——— PBq (—— kCi)
j. Performance certification :
(performance certificates as per
(AERB/SS/3 (Rev. 1)/ISO 2919
(1980) with bend test
requirements for L/D > 15)
k. Source rack assembly details and location of the pencils in the rack
( provide with sketch)
TABLE - 1
POSITION OF SOURCES IN SOURCE RACK AFTER
SOURCE LOADING

S. No. ISU identification Activity Date Position Remarks

number
1

2.

9. Acceptance Test Reports after Source Loading Operations

(a) Dose rate profile measurement in the entire facility, strength of
radiation source.
(b) Performance of radiation monitoring and control interlocks
(c) Performance of personnel monitors
(d) Dose concentration measurement with and without ventilation fan
functioning
(e) Assurance and effectiveness of control functions and interlocks
Sketch of the facility and location of dose rate monitoring points and
maximum/minimum dose rate levels should include :
(i) Name of persons carrying out the measurement
(ii) Instrument used in the radiation survey
(iii) Confidence limits of radiation level measurements
(iv) Background radiation levels in each location of measurement.

116
10. List of Critical Safety Components
The manufacturer of radiation processing plant shall provide to the operating
organisation a complete list of components as per following classification:
Group A : Replaceable by manufacturer or with his explicit Consent
Group B : Replaceable to exact specifications
Group C : Replaceable without restriction

117
 APPENDIX-2E
(Refer section 3.2.1.4)

RADIATION PROTECTION MANUAL OF GAMMA

RADIATION PROCESSING FACILITY (GRAPF)
(OPERATIONAL, MAINTENANCE, EMERGENCY ASPECTS)

A. ADMINISTRATION AND SAFETY ASSURANCE

(a) Administrative hierarchy/organisational set up
(b) Authorised personnel - Training and qualification of plant
personnel, their knowledge in radiation
safety, responsibilities of personnel, their
availability in adequate number,
Policies in case of long leave/absence of
certified personnel
(c) Local safety committee - constitution, functions and responsi-
bilities
(d) Procedures for reporting to the regulatory agency on unusual
occurrences and periodic radiation safety status
(e) Procedures in case of change or repairs of safety system /interlocks,
certification of log book entry by FIC/RSO
(f) Record of maintenance - source storage, maintenance schedule,
radiation monitoring, calibration of
survey meters, etc.
(g) Control and distribution of irradiator operating keys
(h) Industrial safety aspects - fire equipment, safety accessories etc.
(i) Facility security arrangements, fencing and personnel movement
control etc.
(j) Removal and storage of contaminated material, if any.
(k) Medical assistance - First aid facility, location, periodic
medical examination (once a year),
medical facilities and treatment facilities
for radiation incidents
B. MONITORING
(a) Radiation monitoring - Type of area monitors, sensitivity, survey
meters, range,

118
 location, interlock alarm set levels (DM
plant/Unloading bay, control room) and
radiation survey meter
(b) Contamination - On line monitoring and sample measure-
monitoring ment, method of collecting samples of
pool water, accessible surfaces of source
raise system)
(c) Personnel monitoring - Number of PM badges, procedure for
their issuance, safe place for storage, etc.
C. OPERATIONAL PROCEDURES
(a) Sequential procedures for raising the source as per the design (with
flow chart)
(b) Familiarisation and procedure for modifications
D. MAINTENANCE PROCEDURE FOR SAFETY SYSTEMS/INTER-
LOCKS
(a) Periodic maintenance - Daily/weekly/monthly/quarterly/yearly:
items, procedures and schedules
(b) Procedure for maintenance of D.M. water supplies
(c ) Maintenance and checking of alarm/warning devices
E. SOURCE REPLENISHMENT PROCEDURES
(i) Details of the agency responsible for source supply & source loading
operation
(ii) Procedure for transporting the source flask from the source
manufacturer to the facility
(iii) Procedure for unloading the source flask at the facility
(iv) Procedure for taking the source flask into & out of the irradiation
cell
(v) Procedure for lifting the source flask down/up from the water pool
(vi) Technical speciation & test certificate of devices used for lifting the
source flask (hoist etc.)
(vii) Procedure for transferring the sources from the flask to the source
frame
(viii) List of source handling tools, equipment and safety accessories used
for source loading operation

119
F. EMERGENCY PLANNING AND PROCEDURES
(a) Organisational structure and communication links
(b) Name, address, and telephone numbers of agencies to be contacted
in case of emergency
(c) Emergency contact telephone/telex nos. and address of
(i) Head of institution
(ii) Facility-in-charge
(iii) Radiological safety officer (RSO)
(iv) Regulatory agency (AERB )
(v) Fire officer (Local)
(vi) Local fire station
(vii) Local police
(viii) Local medical hospital, Radiation therapy hospitals (Nearest)
(ix) Radiation source supplier
(d) Type of emergencies envisaged - Prevention/handling of emergencies,
investigation methods, etc. during major leaks of water, explosion
or fire or smoke, radiation emergency, crisis management in case of
emergency, earthquake, floods, other natural calamities.

120
 APPENDIX-2F
(Refer section 3.2.1.5)

QUALITY ASSURANCE MANUAL (QAM) FOR

GAMMA RADIATION PROCESSING FACILITY (GRAPF)

A. QUALITY ASSURANCE PROGRAM (QAP)

(i) An adequate quality assurance (QA) program, including appropriate
quality control measures, shall be established for the design and
manufacture, construction, operation and industrial safety of
irradiators. Compliance with the ISO 9000 or IS 14000 series is
desirable. Records of all QA procedures shall be maintained for the
entire life of the irradiator.
(ii) Follow the quality assurance requirement specified in Appendix-B
of AERB safety standard titled ‘Land Based Stationary Gamma
Irradiators’ [AERB/RF-IRRAD/SS-6 (Rev.1); 2007].
B. QUALITY ASSURANCE IN DESIGN OF GRAPF
1. Quality Assurance Programme
The responsible organization shall develop and implement a QA programme,
which describes the overall arrangements for the management, performance
and assessment of the GRAPF. This programme should also provide the
means to ensure that all work is suitably planned, correctly performed and
properly assessed. Procedures should be defined by the responsible
organization for control of design activities to ensure that the design of the
GRAPF fulfils the specified requirements.
1.1 Grading
A graded approach based on the relative importance to radiological safety of
each item, service or process shall be used.
1.1.1 The design activities, which could be graded, include:
(a) The level and detail of analysis of design
(b) The need for and level of design review and approval
(c) The degree of verification of design
(d) The controls applied to design change
(e) The detail of design records and their retention times
(f) The need for alternative calculations to be carried out

121
 (g) The need to qualify or test the design output
(h) The need for qualification tests for design
1.2 Organisation
The responsible organisation shall identify the principal designer who has
responsibility for specifying the design requirements and for approving the
design output on its behalf.
1.3 Interfaces
Interface arrangements shall be agreed between organisations involved in
design activities. Interface that should be addressed are for example:
(a) Interfaces between technical disciplines within the design
organisation
(b) Principal designer with:
(i) Siting organisation
(ii) Construction organisation
(iii) Commissioning organisation
(iv) Operating organsiation
(v) Decommissioning organsiation
(vi) Regulatory body
1.4 Planning
Plans used in design should include the following where appropriate:
(a) Scope of work, including work carried out by other organisations
(b) Design methods
(c) Software requirements (software to be developed or software codes
to be validated for use)
(d) Test requirements, including qualification tests, prototype, seismic,
etc.
(e) Design review, verification and validation requirements
(f) Resource requirements
(g) Special training requirements
(h) Schedule of activities
(i) Points at which checks of the design process will take place and the
frequency of such checks

122
 (j) Inputs from safety, reliability, maintainability, human factors,
standardisation and other disciplines.
1.5 Non-conformance Control and Corrective Actions
A system for the control of non-conformances and their corrective actions
should be established.
1.6 Document Control and Records
Procedures for the preparation, review, approval, issue, modification and
control of documents shall be established.
C. QUALITY ASSURANCE DURING CONSTRUCTION OF CIVIL
ENGINEERING STRUCTURES OF GRAPF
1. Quality Assurance Programme
The responsible organisation shall develop and implement a QA programme,
which describes the overall arrangements for the management, performance
and assessment of civil engineering structures for gamma irradiators during
construction. This programme should provide the means to ensure that all
work is suitably planned, correctly performed and properly assessed in order
to implement design intent in the construction.
1.1 Grading
Work procedures should be defined for control of construction activities at
site and it should be reviewed and approved before use. A graded approach
based on the relative importance to safety of each item, service or process
shall be used. The construction activities, which could be graded, include:
(a) Qualification of special construction processes and the personnel to
carry them out
(b) Detail and need for inspection plans
(c) Level of traceability
(d) Level of in process controls and need for hold points
(e) Records and archived samples
1.2 Organisation
The responsible organisation should formally appoint a person on its staff to
be responsible for construction activities. The appointed person should have
the necessary resources within the construction organisation to discharge the
following responsibilities:

123
 (i) Ensuring that construction and installation work is carried out in
accordance with design specifications, drawings, procedures and
instructions, including the implementation of specified QA
requirements.
(ii) Ensuring that construction and installation work undertaken,
including work by suppliers, is co-ordinated, conducted and
completed in accordance with planned programmes of work.
(iii) Controlling access to the construction site.
1.3 Interfaces
Interface arrangements should be agreed between the construction
organisation, suppliers and other organisational units performing the work.
They should be defined in writing and should be included in procurement
documents. Interfaces that should be addressed are:
(a) Construction organization with supplier
(b) Construction organization with operating organisation
(c) Suppliers with sub-suppliers
(d) Construction organisation with the principal designer
(e) Construction organisation with siting organization
(f) Interfaces between construction organisation and the regulatory body
1.4 Planning
All construction activities should be planned. The plan should define:
(a) The activities to be performed in manageable units
(b) The planned sequential order and duration of these activities
(c) The resource allocation for each activity
1.5 Non-conformance Control and Corrective Actions
The non-conformances that are required to be reported to the construction
organisation should be identified. Suitable corrective action should also be
recorded.
1.6 Document Control and Records
Procedures for the preparation, review, approval, issue, modification and
control of documents should be established. The record system should be
established which includes the arrangements and responsibilities for the
categorisation, receipt, indexing, storage, retrieval and disposal of construction
records. Records should include all those, which record the as-built condition
of structures, systems and components.

124
1.7 The civil engineering construction should be carried out following the relevant
Indian standard codes/specifications. Quality of civil construction should
satisfy the requirements of appropriate Indian standard codes/specifications
and that of product specifications. Typical list of topics to be covered in QA
programme for the civil engineering construction is given as below:
(a) Formwork, shuttering and pre-construction activities
(b) Concreting and curing
(c) Post concrete inspection
(d) Repair
(e) Fabrication and erection of embedded parts (EP)
(f) Fabrication and erection of structural steel
(g) Brick work
(h) Grounding network
(i) Painting for steel structure
(j) Finishing and repair control
(k) Painting of main plant structures/concretes faces
(l) List of procedures
(m) Miscellaneous items such as organisation chart of QA civil, flow
chart showing production of good uniform concrete, schematic
diagram on procedure of concrete mix design etc.
(n) Density of the concrete in construction of walls and roof of irradiation
cell shall be maintained at least 2.5 g/cc and it shall be ensured that
no voids or air gaps are present during concrete filling.
D. INDUSTRIAL SAFETY DURING CONSTRUCTION OF CIVIL
ENGINEERING STRUCTURES
A policy reflecting industrial safety regulations should be established for all
personnel, including suppliers and visitors. These should be in line with the
prevailing factory rules. The policy should include arrangements for the
effective planning, organisation, monitoring and review of the preventive
and protective measures.
Management should provide all necessary support to the Contractor to ensure
health and safety of the construction personnel.
(i) Job hazard analysis should be prepared before the start of
construction.
(ii) Industrial safety at the construction site should be enforced by a
safety officer.

125
 (iii) All construction equipment should be tested prior to its use.
(iv) Construction personnel should be given orientation program on
industrial safety.
(v) Accident statistics should be maintained at the construction site.
(vi) Appropriate arrangements for fire safety and first aid should be
available.
E. QUALITY CONTROL - RESPONSIBILITY OF MANUFACTURER/
DESIGNER
(i) Equipment and Instrument quality and certification
(ii) Manufacturing material quality, tolerance of parts, fabrication
specifications, inspection manufacturing and tests adopted, quality
assurance procedures.
(iii) Quality of components used
(iv) Certification of wiring, electrical and mechanical safety
(v) Documentation of quality assurance and control procedures
(vi) Specifications of wire rope, source rack, hydraulic piping and pumps,
sensors and their quality assurance

126
 (APPENDICES 3B-I, 3B-II,3B-III,3C,3D-I & II, 3D-III,3E, 3F ARE FOR
ACCELERATOR FACILITIES)

APPENDIX-3B-I
(Refer section 3.2.2.3)

FORMAT OF THE PRELIMINARY SAFETY ANALYSIS REPORT FOR

INDUSTRIAL ACCELERATOR RADIATION PROCESSING FACILITY
(IARPF)

[PSAR should be submitted to AERB in this format, duly signed by Head of

the organisation (employer)]

1. Name and address of the applicant :

2. Details of supplier :
Name and address of the applicant/local
supplier with PIN code (in block letters)
3. Details of system parameters :
Model/type designation :
Year and country of manufacture :
Maximum voltage - MV
Maximum beam current - mA
Vacuum - Torr
Maximum beam dimensions - mm
Scan amplitude/scan angle -
Operational life of the device ( in hours ) :
Leakage radiation levels at a distance
of one metre from the source
when radiation beam is ‘ON’ (specify
for maximum energy and mode) : …...........mGy/h.........MV/
MeV/Photon/Electron
Built-in safety features/operation :
procedures to prevent any radiologically
unsafe malfunction of the equipment
(Please attach relevant documents such
as installation manual, operation/
servicing manual)

127
 Standards to which the
accelerator comply :
Details of beam energy and
current calibration facility :
4. Documentation Detail
Design Detail : Summary of accelerator design and general working
principles, specifications and physical parameters of the
system and user objectives.
Design manual of the accelerating device should include
(a) Drawing of the irradiation head showing the radiation shielding and
materials of construction
(b) Drawings along with the functional description of safety related
control systems and devices
(c) National standards to which the equipment conforms (English
translation of the standard is to be provided)
(d) Test report on the performance of the accelerator demonstrating the
compliance with the National Standard or IEC 601-1 and IEC 601-
2-1
(e) Certificate from the competent authority of country of design/
manufacture to the effect that the equipment is approved for industrial
use.
(f) Beam injection and transport system detailing their design,
construction and testing.
Site characteristics : Location, occupancy in site area as well as
surrounding population up to 30 meters radius,
load bearing capacity of soil and rock, structural
design criteria, foundation, meteorology,
seismology etc.
Accelerator facility : Description of general layout, details of buildings,
equipment, pressure vessels, vacuum system, beam
injection and transport system, details of control
console facility to view active and passive
engineered controls etc.
Biological shield - Final sketch giving details of shielding wall
surrounding the source, wall thickness, roof
thickness, labyrinth access, openings, voids,

128
 reinforcements, embedment etc. in the biological
shield.
- Shield material, density, and quality assurance
during construction
- Dose rate profiles anticipated at various locations:
(maximum and minimum values). Indicate them
on a sketch of the facility - control room, roof,
access doors, openings and where personnel are
expected to be stationed for work or otherwise.
- Maximum dose rate anticipated
. Lay out of the enclosure along with the location of the Accelerator device
(a) Shielding design detail and drawing of the accelerator enclosure,
which includes
(i) Radiation shielding: concrete blocks, lead bricks, iron plates
etc.
(ii) Barriers: fences, locked gates, doors etc.
(b) Area radiation monitors
(c) Ventilation facility details
(d) Access sensors or interlocks : magnetic and mechanical
(e) Search and rescue control
(f) Warning indicators (status lights, alarms, posted procedures)
(g) Inventory and labeling of control devices
5. Documentation Detail of Services
(a) Electrical power and power supply systems (including emergency
power supply) major electrical equipment, illumination, lift, hoist,
cranes etc.
(b) Air conditioning and ventilation system
(c ) Cooling water supply system
(d) Compressed air system
(e) Insulating gas supply system
(f) Communication system
6. Safety Features including Hazard Evaluation
(a) Design safety of buildings and equipment

129
 (b) Accelerator facility
(c ) Electrical system and equipment
(i) Power and control cables-specifications
(ii) Cable ducting
(iii) Safety fencing of high voltage locations
(iv) Earthing
(v) Electromagnetic interference and suppression
(d) Air conditioning and ventilation
(e) Vacuum system
(f) Cooling water supply system
(g) Compressed air system
(h) Insulating gas supply system
(i) Communication system
(j) Control system
(k) Pressure vessels
(l) Production and removal of noxious gases
(m) Others, if any -
7. Radiation Safety
(a) Radiation safety policy
(b) Dose limits
(c) Planned exposure (operational hours/week)
(d) Planned special exposure
(e) Design features - shielding etc.
(f) Radiation monitoring and alarm system (including interlocks)
(g) Induced activity estimation - radiation levels due to induced activity,
induced gaseous airborne activity (if applicable)
(h) Other radiation safety considerations - radioactive waste, postulation
of radiation accident, analysis and action, administrative
considerations (if applicable)
(i) Analysis of potential radiation exposure scenarios
8. Chemical Safety
List of chemicals used with quantities, their toxicity and hazards, safety
considerations, analysis of potential release scenarios and preventive and

130
 other action to be taken [e.g. ozone production and ozone depleting substance,
flammable gases, liquids, oxygen deficiency hazard (SF6), biologically
hazardous material, cryogenic fluids, etc.]
9. Fire Safety
Fire and explosion hazards, means of escape, access, fire detection and alarm
system, fire fighting system - fire hydrants, dry risers, fire extinguishers etc.
10. Personnel Safety
Safety policy, organisation, functions of safety personnel, responsibilities,
general safety rules, accident prevention program, safety equipment and
procurement, safety inspection, housekeeping, accident reporting,
investigation, preventive measures, training, medical facilities including first
aid.
11. Normal and Emergency Operation Procedures of the Accelerating Device
12. Safety in Operation and Maintenance
(i) Startup procedure
(ii) Shutdown procedure
(iii) Emergency shutdown procedure
(iv) Search and secure
(v) Entry into beam hall during beam-on condition
(vi) Others (eg. gas handling procedure) please specify.
Emergency planning and procedures
(types of emergencies envisaged, preventive measures handling of
emergencies, investigation etc.)
(i) During major leaks in the pressure vessel
(ii) During explosion and fire
(iii) During general fires
(iv) During beam loss/window foil puncture/target rupture etc.
(v) During radiation emergency such as overexposure/activation etc.
(vi) Crisis management in case of major emergency
13. Pre-operational Radiation Survey Report (background radiation in and vicinity
of the enclosure)
14. Details of Quality Assurance Program during Design and Construction of the
Facility

131
15. Details of Disposal Procedures and Provisions for Safe Disposal of
Radioactive Waste, if applicable
16. Details Regarding the Decommissioning of the Facility
We certify that all the information provided by us is true and correct to the
best of our knowledge and belief.

Place: Signature:
Date: Name:
Designation:
Documents to be attached
(i) Lay out of the enclosure along with the location of the Accelerator device
(ii) Shielding design details and drawing of the accelerator facility setup
(iii) Other supportive documents mentioned above.

132
 APPENDIX-3B-II
(Refer section 3.3.1)

FORMAT OF THE PRELIMINARY SAFETY ANALYSIS REPORT FOR

PARTICLE RESEARCH ACCELERATOR FACILITIES
(PARF) < 10MeV

[ PSAR should be submitted to AERB in this format, duly signed by

Head of the organisation (employer) ]

1. Name and address of the applicant :

2. Details of supplier :
Name and address of the applicant/local
supplier with PIN code (in block letters)
3. Details of system parameters :
Model/type designation :
Year and country of manufacture :
Maximum voltage - MV
Maximum beam current - mA
Vacuum - Torr
Maximum beam dimensions - mm
Scan amplitude/scan angle -
Particles to be accelerated and purpose :
Operational life of the device (in hours ) :

Leakage radiation levels at a distance

of one metre from the source
when radiation beam is ‘ON’ (specify for
maximum energy and mode) : ...........mGy/h.........MV/
MeV/Photon/Electron
Built-in safety features/operation :
procedures to prevent any radiologically
unsafe malfunction of the equipment
(Please attach relevant documents such
as installation manual, operation/servicing
manual)
Standards to which the
accelerator comply :

133
 Details of beam energy and
current calibration facility :
4. Documentation Detail
Design Detail : Summary of accelerator design and general working
principles, specifications and physical parameters of the
system and user objectives.
Design manual of the accelerating device which includes
(a) Drawing of the accelerator, beam transportlines and target showing
the radiation shielding and materials of construction
(b) Drawings along with the functional description of safety related
control systems and devices
(c) National standards to which the equipment conforms (English
translation of the standard is to be provided)
(d) Test report on the performance of the accelerator demonstrating the
compliance with the National Standard or IEC 601-1 and IEC
601-2-1
(e) Certificate from the competent authority of country of design/
manufacture to the effect that the equipment is approved for industrial
use.
(f) Beam injection and transport system detailing their design,
construction and testing.
Site characteristics : Location, occupancy in site area as well as
surrounding population up to 1000 meters radius,
load bearing capacity of soil and rock, structural
design criteria, foundation, meteorology,
seismology etc.
Accelerator facility : Description of general layout, details of buildings,
equipment, pressure vessels, vacuum system, beam
injection and transport system, details of control
console facility to view active and passive
engineered controls, Fail safe (any defect or
component failure prevent accelerator operation)
and operational independent mechanism etc.
Biological shield - Final sketch giving details of shielding wall
surrounding the source, wall thickness, roof
thickness, labyrinth access, openings, voids,
reinforcements, embedment etc. in the biological
shield.

134
 - Shield material, density, and quality assurance
during construction
- Dose rate profiles anticipated at various locations:
(maximum and minimum values). Indicate them
on a sketch of the facility - control room, roof,
access doors, openings and where personnel are
expected to be stationed for work or otherwise.
- Maximum dose rate anticipated
Lay out of the enclosure along with the location of the Accelerator device
(a) Shielding design detail and drawing of the accelerator enclosure,
which includes :
(i) Radiation shielding: concrete blocks, lead bricks, iron plates
etc.
(ii) Barriers: fences, locked gates, doors etc.
(b) Area radiation monitors
(c) Ventilation facility details
(d) Access sensors or interlocks : magnetic and mechanical
(e) ‘Crash’ or ‘scram’ buttons either mounted on walls or at doors and
gates
(f) Search and rescue control
(g) Warning indicators (status lights, alarms, posted procedures)
(h) Inventory and labeling of control devices
5. Documentation Detail of Services
(a) Electrical power and power supply systems (including emergency
power supply) major electrical equipment, illumination, lift, hoist,
cranes etc.
(b) Air conditioning and ventilation system
(c ) Cooling water supply system
(d) Compressed air system
(e) Insulating gas supply system
(f) Communication system
(g) Injector gas handling system-system description, characteristics of
the gas (properties, specifications, purification etc.)

135
 (h) Laboratory, workshops, stores etc.
(i) Other services - please specify
(j) Control of various subsystems, description, operation etc.
Summary list of potential hazards and safety measures to be taken
(a) During precommissioning trials of all systems and subsystems
(b) During commissioning
(c) During operation and maintenance
6. Safety Features including Hazard Evaluation
(a) Design safety of buildings and equipment
(b) Accelerator facility
(c ) Electrical system and equipment
(i) Power and control cables-specifications
(ii) Cable ducting
(iii) Safety fencing of high voltage locations
(iv) Earthing
(v) Electromagnetic interference and suppression
(d) Air conditioning and ventilation
(e) Vacuum system
(f) Cooling water supply system
(g) Compressed air system
(h) Insulating gas supply system
(i) Communication system
(j) Control system
(k) Production and removal of noxious gases
(l) Pressure vessels
(m) Others, (if any)
7. Radiation Safety
(a) Radiation safety policy
(b) Dose limits
(c) Planned exposure (operational hours/week)
(d) Planned special exposure

136
 (e) Design features - shielding etc.
(f) Radiation monitoring and alarm system (including interlocks)
(g) Induced activity estimation - radiation levels due to induced activity,
induced gaseous airborne activity (if applicable)
(h) Other radiation safety considerations - radioactive waste, postulation
of radiation accident, analysis and action, administrative
considerations (if applicable)
(f) Analysis of potential radiation exposure scenarios
8. Chemical Safety
List of chemicals used with quantities, their toxicity and hazards, safety
considerations, analysis of potential release scenarios and preventive and
other action to be taken [e.g. ozone production and ozone depleting substance,
flammable gases, liquids, oxygen deficiency hazard (SF6), biologically
hazardous material, cryogenic fluids, etc.]
9. Fire Safety
Fire and explosion hazards, means of escape, access, fire detection and alarm
system, fire fighting system- fire hydrants, dry risers, fire extinguishers etc.
10. Personnel Safety
Safety policy, organisation, functions of safety personnel, responsibilities,
general safety rules, accident prevention program, safety equipment and
procurement, safety inspection, housekeeping, accident reporting,
investigation, preventive measures, training, medical facilities including first
aid.
11. Normal and emergency operation procedures of the accelerating device
12. Safety in Operation and Maintenance
(i) Startup procedure
(ii) Shutdown procedure
(iii) Emergency shutdown procedure
(iv) Search and secure
(v) Entry into beam hall during beam - ON condition
(vi) Others (eg. gas handling procedure) please specify.
Emergency planning and procedures
(types of emergencies envisaged, preventive measures handling of
emergencies, investigation etc.)

137
 (i) During major leaks in the pressure vessel
(ii) During explosion and fire
(iii) During general fires
(iv) During beam loss/ window foil puncture/target rupture etc.
(v) During radiation emergency such as overexposure/activation etc.
(vi) Crisis management in case of major emergency
13. Pre-operational Radiation Survey Report (background radiation in and vicinity
of the enclosure)
14. Details of Quality Assurance Program during Design and Construction of the
Facility
15. Details of Disposal Procedures (if applicable)
(a) Storage/Shielding or activated materials for reuse or disposal
(b) Storing facility for radioactive waste and disposal procedure (waste
is segregated into appropriate containers, inventory cards with
radioactivity symbol)
(c) Activity in cooling water
16. Details Regarding the Decommissioning of the Facility (if applicable)
We certify that all the information provided by us is true and correct to the
best of our knowledge and belief.
Place: Signature:
Date: Name:
Designation:
Documents to be attached
(i) Lay out of the enclosure along with the location of the accelerator device
(ii) Shielding design details and drawing of the accelerator facility setup
(iii) Other supportive documents mentioned in the application above.

138
 APPENDIX-3B-III
(Refer section 3.7.8 .2)

FORMAT OF THE PRELIMINARY SAFETY ANALYSIS REPORT FOR

INDUSTRIAL ACCELERATOR FACILITY (IAF) FOR NDT

[PSAR should be submitted to AERB in this format, duly signed by

Head of the organisation (employer)]

1. Name and address of the applicant :

2. Details of supplier :
Name and address of the applicant/local
supplier with PIN code (in block letters)
3. Details of system parameters :
Model/type designation :
Year and country of manufacture :
Maximum voltage - MV
Maximum beam current - mA
Vacuum - Torr
Maximum beam dimensions - mm
Scan amplitude/scan angle -
Operational life of the device (in hours) :
Leakage radiation levels at a distance
of one metre from the source
when radiation beam is ‘ON’ (specify for
maximum energy and mode) : …...........mGy/h.........MV/
MeV/Photon/Electron
Built-in safety features/operation :
procedures to prevent any radiologically
unsafe malfunction of the equipment
(Please attach relevant documents such
as installation manual, operation/servicing
manual)
Standards to which the
accelerator comply :
Details of beam energy and
current calibration facility :

139
4. Documentation Detail
Design Detail : Summary of accelerator design and general working
principles, specifications and physical parameters of the
system and user objectives.
Design manual of the accelerating device which includes
(a) Drawing of the irradiation head showing the radiation shielding and
materials of construction
(b) Drawings along with the functional description of safety related
control systems and devices
(c) National standards to which the equipment conforms (English
translation of the standard is to be provided)
(d) Test report on the performance of the accelerator demonstrating the
compliance with the National Standard or IEC 601-1 and IEC 601-
2-1
(e) Certificate from the competent authority of country of design/
manufacture to the effect that the equipment is approved for industrial
use
(f) Beam injection and transport system detailing their design,
construction and testing
Site characteristics : Location, occupancy in site area as well as
surrounding population up to 30 meters radius,
load bearing capacity of soil and rock, structural
design criteria, foundation, meteorology,
seismology etc.
Accelerator facility : Description of general layout, details of buildings,
equipment, pressure vessels, vacuum system, beam
injection and transport system, details of control
console facility to view active and passive
engineered controls etc.
Biological shield - Final sketch giving details of shielding wall
surrounding the source, wall thickness, roof
thickness, labyrinth access, openings, voids,
reinforcements, embedment etc. in the biological
shield.
- Shield material, density, and quality assurance
during construction
- Dose rate profiles anticipated at various locations:
(Maximum and minimum values). Indicate them

140
 on a sketch of the facility - control room, roof,
access doors, openings and where personnel are
expected to be stationed for work or otherwise.
- Maximum dose rate anticipated
Lay out of the enclosure along with the location of the accelerator device
with
(a) Shielding design detail and drawing of the accelerator enclosure,
which includes:
(i) Radiation shielding: concrete blocks, lead bricks, iron plates
etc.
(ii) Barriers: fences, locked gates, doors etc.
(b) Area radiation monitors (Radiation hazard control setup details)
(c) Ventilation facility details
(d) Access sensors or interlocks: magnetic and mechanical
(e) ‘Crash’ or ‘scram’ buttons either mounted on walls or at doors and
gates
(f) Search and rescue control
(g) Warning indicators (Status lights, alarms, posted procedures)
(h) Inventory and labeling of control devices
5. Documentation Detail of Services
(a) Electrical power and power supply systems (including emergency
power supply) major electrical equipment, illumination, lift, hoist,
cranes etc.
(b) Air conditioning and ventilation system
(c) Cooling water supply system
(d) Compressed air system
(e) Insulating gas supply system
6. Radiation Safety
(a) Radiation safety policy
(b) Dose limits
(c) Planned exposure (operational hours/week)
(d) Planned special exposure
7. Details of Quality Assurance Program during Design and Construction of the
Facility

141
8. Normal and Emergency Operation Procedures of the Accelerating Device
9. Details Regarding the Decommissioning of the Facility (if applicable)
We certify that all the information provided by us is true and correct to the
best of our knowledge and belief.

Place: Signature:
Date: Name:
Designation:
Documents to be attached
(i) Lay out of the enclosure along with the location of the Accelerator device
(ii) Shielding design details and drawing of the accelerator facility setup
(iii) Other supportive documents mentioned in above

142
 APPENDIX-3C
(Refer section 3.2.2.4 for IARPF and PARF<10 MeV)
(Refer section 3.7.8.3 for IAF-NDT)

FORMAT FOR ACCEPTANCE TEST REPORT (ATR) FOR

ACCELERATOR FACILITIES
[IARPF, IAF-NDT AND PARF<10MeV]

(All the safety systems/ sensors/ signals/ interlocks should be tested atleast
15-20 times, with accelerator ON and OFF condition and consolidated
report in the format prescribed herewith shall be submitted)

1. General
Name and address of the :
operating institution
Telephone No. :
Fax :
Facility-in-charge :
Radiological safety officer :
AERB approval details and reference :
Date of expiry : ___________
Type of Facility : Radiation processing/ :
Research (<10MeV)/NDT
2. Accelerator Specifications

Maximum voltage (MV)

Maximum beam current (mA)
Particles accelerated
Vacuum (Torr)
Maximum beam dimensions (mm)
Scan amplitude/Scan angle

3. Performance of Beam Calibration Devices

Type of calibration Expected response Observed

of control system response of the
control system
Energy calibration
Current calibration

143
4. Performance of Safety System/Interlocks

Safety System/ Test conducted Expected Observed

Interlock with response of response of the
location control system control system

5. Radiation Survey of the Facility during the Beam ON Condition at Maximum

Parameters

Location Nature of Radiation level Detector used

occupancy

6. Performance of Installed On-line Radiation Monitors and Contamination

Monitor

Installed Detector Make & Range Date of Alarm Functional

location type model calibration level performance

7. Performance of Warning Indicators

Location Type of warning Posted Functional

indicator(s) procedures performance

8. Performance of Various Monitors and Associated Systems

Type of monitor Functional performance

Ozone monitor
Cryogenic leak monitor
Instruments to monitor prompt high
energy radiation
Pulsed beam monitor
RF monitor

144
9. Availability of In-house Facilities (details may be furnished in separate pages)
Type of facility Available/Not available/
Not applicable
Decontamination facility
Personal dosimetry rack facility
Storage of radioactive material
Monitor for coolant system
Monitoring of coolant filter
Radioactive waste management facility
Dosimetry faciity
Ventilation system
Others, if any

10. Availabiliy of the Records

Type of record Available/ Not available/

Not applicable
Record of training and experience of
persons working in the accelerator
facility
Search and secure procedure
Controlled access procedure
Operating procedures
Periodic radiation survey of facility
Periodic contamination surveys
Periodic air sampling
Personnel monitoring records
Unusual occurrences

We hereby certify that the above information is correct to the best of our knowledgeand
belief.
Place: Signature:
Date: Name:
Designation:

Name and Designation

of Facility-in-charge:
Signature:

145
 APPENDIX-3D-I & II
(Refer section 3.2.2.5)

FORMAT OF THE FINAL SAFETY ANALYSIS REPORT FOR IARPF

(This format can also be used for PARF with beam energy <10 MeV)

[FSAR should be submitted to AERB in this format, duly signed by

Head of the organisation (employer)]

A. ORGANISATION AND ADMINISTRATION :

(i) Name and Address of Institution :
(ii) Telephone No. :
(iii) Fax No. :
(iv) Purpose of the Plant
(Industrial Application) :
(v) Design Approval of the Device obtained from AERB
Model :
Technical Specification : Maximum energy _________
Maximum current _________
Particles Accelerated : ________________________
Ref. No. :
Date of issue :
Valid up to :
(vi) Site, Layout and Construction Approval of the facility
obtained from AERB
Ref. No. :
Date of issue :
Valid up to :
B. SAFETY PERSONNEL
(i) Head of Institution :
(ii) Facility-in-charge :
(iii) Radiological Safety Officer :
AERB Approval ref. :
Date of issue :
Valid up to :

146
 DETAILS OF DOCUMENTS TO BE SUBMITTED

Required documents
Technical description of accelerator design and working procedure with drawings
Precommissioning test reports with results
Shielding design and of installation survey (along with drawings and layout)
Electrical circuit diagram and other interlocks of the accelerating device (inbuilt
safety features)
Electrical circuit diagram and other interlocks of the accelerator vault
Provisions and procedures for particle beam energy and beam current calibration
and periodic checks
Quality assurance manual (operation)
Arrangements for personal and environmental monitoring system
Periodic surveys of radioactive contamination if applicable
Radiation safety manual
Availability of local safety committee and their safety evaluation report
Details deviations from approved beam line components, accelerator vessel, layout,
etc.
Decommissioning procedures of the accelerator facility (if applicable)

We certify that all the information provided by us is true and correct to the best of our
knowledge and belief.

Place: Signature:
Date: Name:
Designation:

Documents to be attached : as mentioned above

147
 APPENDIX-3D-III
(Refer section 3.7.8.3)

FORMAT OF THE FINAL SAFETY ANALYSIS REPORT FOR

INDUSTRIAL ACCELERATOR FACILITY (IAF) FOR NDT

[FSAR should be submitted to AERB in this format, duly signed by

Head of the organisation (employer)]

A. ORGANISATION AND ADMINISTRATION :

(i) Name and Address of Institution :
(ii) Telephone No.. :
(iii) Fax No. :
(iv) Head of Institution :
(v) Facility-in-charge :
(vi) Purpose of the Plant :
(Industrial Application)
(vii) Site Layout and Construction Approval obtained
from AERB
Ref. No. :
Date of issue :
Valid up to :
(viii) Design Approval of the Device obtained from AERB
Model :
Technical Specification : Maximum energy__________
Maximum current _________
Particles Accelerated : _______________________
Ref. No. :
Date of issue :
Valid up to :
B. SAFETY PERSONNEL
(i) Radiological Safety Officer :
AERB Approval ref. :
Date of issue :
Valid up to :

148
 DETAILS OF DOCUMENTS TO BE SUBMITTED

Required documents
Summary of accelerator design and general working principles with drawings
Precommissioning test reports with results
Shielding design and of installation survey (along with drawings and layout)
Safety assessment reports
Facility operational and interlocks procedures
Calibration and daily checks (beam calibration/monitors)
Changes in operation, equipment, occupancy etc.
Arrangements for personal and environmental monitoring system
Periodic surveys of radioactive contamination if applicable
Radiation safety manual
Emergency scenarios and its response procedures
Organisational setup with responsibilities
Availability of local safety committee and their safety evaluation report
Details deviations from approved beam line components, accelerator vessel, layout
etc.
Decommissioning procedures of the accelerator facility (if applicable)

We certify that all the information provided by us is true and correct to the best of our
knowledge and belief.

Place: Signature:
Date: Name:
Designation:

Documents to be attached : as mentioned above

149
 APPENDIX-3E
(Refer section 3.2.2.5 for IARPF and PARF<10 MeV)
(Refer section 3.7.8.3 for IAF-NDT)

FORMAT FOR RADIATION PROTECTION MANUAL FOR

ALL ACCELERATOR FACILITIES
[IARPF, IAF-NDT AND PARF <10MeV]

(OPERATION, MAINTENANCE, EMERGENCY ASPECTS)

A. ADMINISTRATION AND SAFETY ASSURANCE

(a) Administrative hierarchy/organisational set up
(b) Authorised personnel - Training and qualification of facility personnel,
their knowledge in radiation safety, responsibilities
of each of personnel, their availability in adequate
number, policies in case of long leave/absence of
certified personnel
(c) Local safety committee: constitution, functions and responsibilities
(d) Procedures for reporting to the regulatory agency on unusual occurrences
and periodic radiation safety status
(e) Procedures in case of change or repairs of H.V. system, safety system/
interlocks, certification of log book entry by RSO
(f) Record of maintenance - maintenance schedule, radiation monitoring, and
calibration of survey meters, etc.
(g) Industrial safety aspects - fire equipment, safety accessories etc.
(h) Facility security arrangements, fencing and personnel movement control etc.
(i) Removal and storage of contaminated material, if any.
(j) Medical assistance - First aid facility, location, periodic medical examination
(once a year), medical facilities and treatment facilities for radiation incidents
B. MONITORING
(a) Radiation monitoring - Type of area monitors, sensitivity range,
location, interlock alarm set levels
(b) Contamination monitoring - On line monitoring and sample measurement,
method of collecting samples

150
(c) Personnel monitoring - Number of PM badges, procedure for their
issuance, safe place for storage, etc.
C. OPERATION PROCEDURES
‘Beam ON’ procedures be established, documented and displayed in the
console area
D. MAINTENANCE PROCEDURE FOR SAFETY SYSTEMS/INTER-
LOCKS
(a) Periodic maintenance - Daily/weekly/monthly/quarterly/yearly
(Items, procedures and schedules)
(b) Procedure for maintenance of cooling water used for cooling target beam
line components, etc
(c) Procedure for maintenance of air cooling mechanism maintenance and
checking of alarm/warning devices
E. EMERGENCY PLANNING AND PROCEDURES
(a) Organisational structure and communication links
(b) Name, address and telephone numbers of agencies to be contacted in case of
emergency
(c) Emergency contact telephone/ telex nos. and address of
(i) Head of Institution
(ii) Facility-in-charge
(iii) Radiological safety officer (RSO)
(iv) Regulatory agency (AERB)
(v) Fire safety officer (Local)
(vi) Local fire station
(vii) Local police station
(viii) Local medical hospital, radiation therapy hospitals (nearest)
(d) Type of emergencies envisaged - Prevention/handling of emergencies,
investigation methods, etc. during explosion or fire or smoke, radiation
emergency, crisis management in case of emergency, earthquake, floods, other
natural calamities.

151
 APPENDIX-3F
(Refer sections 3.2.2.3 for IARPF.and PARF<10 MeV)
(Refer section 3.7.8.2 and 3.7.8.3 for IAF NDT)

QUALITY ASSURANCE MANUAL (QAM) FOR

ACCELERATOR FACILITIES
[IARPF, IAF-NDT, PARF<10MeV]

A. QUALITY ASSURANCE PROGRAM (QAP)

An adequate quality assurance (QA) program, including appropriate quality
control measures, shall be established for the design and manufacture,
construction and operation of accelerator. Compliance with the ISO 9000 or
IS 14000 series is desirable. Records of all QA procedures shall be maintained
for the entire life of the accelerator.
B. QUALITY ASSURANCE IN DESIGN:
1.1 Quality Assurance Programme
The responsible organisation shall develop and implement a QA programme,
which describes the overall arrangements for the management, performance
and assessment of the accelerator. This programme should also provide the
means to ensure that all work is suitably planned, correctly performed and
properly assessed. Procedures should be defined by the responsible
organisation for control of design activities to ensure that the design of the
accelerator fulfils specified requirements.
1.2 Grading
A graded approach based on the relative importance to radiological safety of
each item, service or process shall be used.
1.2.1 The design activities, which could be graded, include:
(a) The level and detail of analysis of design
(b) The need for and level of design review and approval
(c) The degree of verification of design
(d) The controls applied to design change
(e) The detail of design records and their retention times
(f) The need for alternative calculations to be carried out
(g) The need to qualify or test the design output
(h) The need for qualification tests for design

152
1.3 Organisation
The responsible organisation shall identify the principal designer who has
responsibility for specifying the design requirements and for approving the
design output on its behalf.
1.4 Interfaces
Interface arrangements shall be agreed between organisations involved in
design activities. Interface that should be addressed are for example:
(a) Interfaces between technical disciplines within the design
organisation
(b) Principal designer with:
(i) Siting organisation
(ii) Construction organisation
(iii) Commissioning organisation
(iv) Operating organsiation
(v) Decommissioning organsiation
(vi) Regulatory body
1.5 Planning
Plans used in design should include the following where appropriate:
(a) Scope of work, including work carried out by other organisations
(b) Design methods
(c) Software requirements (software to be developed or software codes
to be validated for use)
(d) Test requirements, including qualification tests, prototype, seismic,
etc.
(e) Design review, verification and validation requirements
(f) Resource requirements
(g) Special training requirements
(h) Schedule of activities
(i) Points at which checks of the design process will take place and the
frequency of such checks
(j) Inputs from safety, reliability, maintainability, human factors,
standardisation and other disciplines.

153
1.6 Non-conformance Control and Corrective Actions
A system for the control of non-conformances and their corrective actions
should be established.
1.7 Document Control and Records
Procedures for the preparation, review, approval, issue, modification and
control of documents shall be established.
C. QUALITY ASSURANCE DURING CONSTRUCTION OF CIVIL
ENGINEERING STRUCTURES OF ACCELERATOR
1.1 Quality Assurance Programme
The responsible organisation shall develop and implement a QA programme,
which describes the overall arrangements for the management, performance
and assessment of civil engineering structures for industrial processing
accelerators during construction. This programme should provide the means
to ensure that all work is suitably planned, correctly performed and properly
assessed in order to implement design intent in the construction.
1.2 Grading
Work procedures should be defined for control of construction activities at
site and it should be reviewed and approved before use. A graded approach
based on the relative importance to safety of each item, service or process
shall be used. The construction activities, which could be graded, include:
(a) Qualification of special construction processes and the personnel to
carry them out
(b) Detail and need for inspection plans
(c) Level of traceability
(d) Level of in process controls and need for hold points
(e) Records and archived samples
1.3 Organisation
The responsible organisation should formally appoint a person on its staff to
be responsible for construction activities. The appointed person should have
the necessary resources within the construction organisation to discharge the
following responsibilities:
(i) Ensuring that construction and installation work is carried out in
accordance with design specifications, drawings, procedures and
instructions, including the implementation of specified QA
requirements.

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 (ii) Ensuring that construction and installation work undertaken,
including work by suppliers, is co-ordinated, conducted and
completed in accordance with planned programmes of work.
(iii) Controlling access to the construction site.
1.4 Interfaces
Interface arrangements should be agreed between the construction
organisation, suppliers and other organisational units performing the work.
They should be defined in writing and should be included in procurement
documents. Interfaces that should be addressed are:
(a) Construction organisation with supplier
(b) Construction organisation with operating organisation
(c) Suppliers with sub-suppliers
(d) Construction organisation with the principal designer
(e) Construction organisation with siting organisation
(f) Interfaces between construction organisation and the AERB
1.5 Planning
All construction activities should be planned. The plan should define:
(a) The activities to be performed in manageable units
(b) The planned sequential order and duration of these activities
(c) The resource allocation for each activity
1.6 Non-conformance Control and Corrective Actions
The non-conformances that are required to be reported to the construction
organisation should be identified. Suitable corrective action should also be
recorded.
1.7 Document Control and Records
Procedures for the preparation, review, approval, issue, modification and
control of documents should be established. The record system should be
established which includes the arrangements and responsibilities for the
categorisation, receipt, indexing, storage, retrieval and disposal of construction
records. Records should include all those, which record the as-built condition
of structures, systems and components.
1.8 The civil engineering construction should be carried out following the relevant
Indian standard codes/specifications. Quality of civil construction should
satisfy the requirements of appropriate Indian standard codes/specifications

155
and that of product specifications. Typical list of topics to be covered in QA
programme for the civil engineering construction is given as below:
(a) Formwork, shuttering and pre-construction activities
(b) Concreting and curing
(c) Post concrete inspection
(d) Repair
(e) Fabrication and erection of embeded parts (EP)
(f) Fabrication and erection of structural steel
(g) Brick work
(h) Grounding network
(i) Painting for steel structure
(j) Finishing and repair control
(k) Painting of main plant structures/concretes faces
(l) List of procedures
(m) Miscellaneous items such as organisation chart of QA civil, flow
chart showing production of good uniform concrete, schematic
diagram on procedure of concrete mix design etc.
(n) Density of the concrete in construction of walls and roof of irradiation
cell/accelerator/beam hall shall be maintained at least 2.5 g/cc and it
shall be ensured that no voids or air gaps are present during concrete
filling.

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 (APPENDICES 4A, 4B-4D, 4C, 4F ARE FOR ACCELERATOR
FACILITIES>10 MeV)

APPENDIX-4A
(Refer section 3.3.2)

FORMAT FOR SITE EVALUATION REPORT FOR PARTICLE

ACCELERATOR RESEARCH FACILITY (PARF>10MeV)

1. Description of the Facility

(a) Specifications of the machine with maximum power
(b) Safety features
(c) End use of the facility.
2. Details of Proposed Site (a radius of 2 km around the site) Covering the
Following Aspects:
(a) Location, area map, topography, terrain, rock, soil, rivers, water
bodies, ocean in the vicinity
(b) A layout diagram of the proposed site, indicating all the units and
the distances between them inside the boundary and the vicinity of
the site in all directions
(c) Geological characteristics of the site-floods, storms, rain
(d) Soil survey report with reference to load bearing of the structure,
elemental analysis of soil including lithium activation of the sub soil
and ground water wherever applicable
(e) Meteorological data of the site
(f) Seismic data (seismic zone) of the site
(g) Meteorological data on wind speed, wind direction, temperature,
rainfall, water logging, flood levels and other factors which might
affect the safety aspects in the operation of the accelerator
(h) Availability of adequate water supply for cooling under all conditions
including fire fighting
(i) Reliability and quality of electrical power available to the accelerator
facility
(j) Population distribution (demography).
3. Justification for and Evaluation of the Particular Site for Locating the Facility

157
4. Hazard Assessment
(a) Identification of hazards
(b) Probable effects on workers, public and the environment, from normal
operation and off-normal operations, accidental conditions and
situation arising out of natural or disruptive factors
(c) Means of mitigation of these hazards
(d) Expected radioactive waste generation in solid, liquid and gaseous
forms; their handling, effluent treatment and disposal method
(e) Radiological impact assessment studies.
5. Facilities Available Near the Site, to Deal with Emergency Situations
6. Details of any existing or planned auxiliary facilities handling radioactive
materials/radiation/industrial toxicants within the site or located nearby.
7. Other Supporting Documents, if any.

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 APPENDIX-4B, 4D
(Refer section 3.3.3, 3.3.4, 3.3.5)

FORMAT FOR (PRELIMINARY/FINAL) SAFETY ANALYSIS

REPORT FOR PARF (>10MeV)

The purpose of Safety Analysis Report (SAR) is to ensure that the measures taken to
minimise the consequences of hazards present in the proposed activity, or to mitigate
their consequences, are sufficient to make the risks of the proposed activity acceptable.
It should contain the following:
1. Introduction
This Chapter should provide a basic understanding of the facility function
and the protection features to the public, workers (health and safety), and the
environment.
2. Executive Summary
The summary should provide an overview of the results and conclusions of
the analysis. The summary should address the results of Chapter 4 and Chapter
5 of the SAR.
3. Site, Facility and Operations Description
(a) This section should describe the accelerator site location and provide
specific data for characterising the site.
(b) This section should also describe the accelerator by providing design
criteria and as-built characteristics for the accelerator, for its
supporting systems, and for components with safety-related functions.
(c) For new facilities and those to undergo major modifications, a fire
hazards analysis is to be included.
(d) How the facility fits into the contractor’s organisation, is to be
described.
(e) The experiments which will use the accelerator should be described,
including those design criteria and characteristics of the experimental
equipment, systems and components, having safety-related functions.
(f) An operation/process description of the accelerator facility should
be provided. Both potential accident and normal operation conditions
for the machine and the experimental program should be
appropriately detailed.
(g) The design process and SAR should consider the worker safety
conditions.

159
 (h) Details of ventilation system for removal of noxious gases generated
should be provided.
4. Safety Analysis
(a) This section should document the accident analysis, including any
systematic methodology (i.e. failure mode and effects analysis, fault
trees, etc.) used for the identification and mitigation of potential
hazards.
(b) This section should discuss the methods used at the accelerator facility
to control and mitigate the potential hazards.
(c) Analysis of design basis or postulated emergency conditions,
including those due to natural or disruptive factors. Demonstration
of adequacy of protective measures provided in the design.
(d) The residual risk to the facility, workers, the public, and the
environment should be discussed.
5. Accelerator Safety Envelope
This section should provide the accelerator safety envelope (ASE) that will
establish and define the limits of operation for the facility/operation.
6. Quality Assurance
This section should describe the quality assurance (QA) program to be applied
to the accelerator facility (Give broad guidelines. In addition QA manual
should be made separately as per Appendix 4F of AERB safety guide AERB/
RF/SG/G-3)
7. Decommissioning and Decontamination Plan
A description of structural and internal features which would facilitate
decommissioning and decontamination of the accelerator complex should be
provided in this section. Waste management of radiological and hazardous
material generation from the decommissioning and decontamination operation
should be discussed. Provisions including adequate financial arrangement
for safe disposal of spent/disused sources should be made.
8. References/Glossary/Abbreviations
In short, the FSAR (SAD) shall contain the following:
(a) A description of (or a reference to) the facility’s function, location,
and management organisation, as well as details of major facility
components and their operation.
(b) Hazards from both normal operation and credible accidents in the
facility and associated onsite and offsite impacts to workers, the
public, and the environment.

160
(c) Sufficient descriptive information and analytical results pertaining
to specific hazards and risks identified during the safety analysis
process, and to provide an understanding of the risks presented by
the proposed operations.
(d) A detailed description of engineered controls (e.g. interlocks and
physical barriers) and administrative controls (e.g. training)
implemented to eliminate, control, or mitigate risks associated with
the operation.
(e) The set of physical and administrative bounding conditions for safe
operations, based on the safety analysis documented in the SAR.
These bounding conditions are known as the accelerator safety
envelope (ASE). Any activity violating the ASE shall be terminated
and immediately notified to AERB.

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 APPENDIX-4C
(Refer section 3.3.4)

FORMAT FOR THE ACCEPTANCE TEST REPORT (ATR) FOR

PARTICLE ACCELERATOR RESEARCH FACILITIES
(PARF >10MeV)

S. Safety system Observations/ Signature with

No. Remarks name and
designation for
accepting the
performance
1. Door Interlock
- Power cutoff after opening
- Signal in control room
- Manual resetting
2. Scram Switches
- Power cut-off after pressing the scram
switch
- Signal in control room
- Manual resetting
3. Area Radiation Monitors Interlock
- Power cut-off after radiation field
increases more than specified
- Signal in the control room
- Local sound alarm
- Calibration of monitors
4. Vacuum Failure
- Identification of loss of vacuum
- Functioning of gate valve
- Response time
5. LCW Cooling System
- Functioning of sensor for temperature,
flow etc.
- Indication in the control room
- Tripping of plant system

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 APPENDIX-4C (CONTD.)
(Refer section 3.3.4)

FORMAT FOR THE ACCEPTANCE TEST REPORT (ATR) FOR

PARTICLE ACCELERATOR RESEARCH FACILITIES
(PARF >10MeV)

S. Safety system Observations/ Signature with

No. Remarks name and
designation for
accepting the
performance
6. Public Address System (PAS)
- Functioning of mike
- Functioning of speakers at all locations
7. Fire Detection System
- Power supply to fire detection system
- Detection of fire
- Alarm local and in control room
- Resetting of alarm
8. Beam Shutter Response
- Functioning
- Response time
9. Beam Loss Monitor
- Functioning of interlock with bending
magnet
- Signal in control room
10. Other safety systems
[Add as applicable]

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 APPENDIX-4F
(Refer section 3.3.2 to 3.3.4)

QUALITY ASSURANCE (QA) MANUAL FOR PARTICLE

ACCELERATOR RESEARCH FACILITY [PARF]
(BEAM ENERGY >10MeV)

A. QUALITY ASSURANCE PROGRAMME DURING CONSTRUCTION

OF PARF>10 MeV
The Licensee shall develop and implement a QA programme which describes
the overall arrangements for the management, performance and assessment
of structures/ systems/components related to civil, mechanical, electrical and
instrumentation aspects of PARF during design and construction. This
programme should specify means to ensure that all work is suitably planned,
correctly performed and properly assessed in order to implement design intent
in the construction.
The QA manual (QAM) should be prepared addressing the following aspects:
A.1 INTRODUCTION
This section should include applicability and scope of the QAM.
A. 2 MANAGEMENT FUNCTIONS
This section should specify the management’s Policy Statement and
Organisation plan. Organisational plan should be documented addressing the
following aspects:
(a) Organisational structure
(b) Functional responsibility
(c) Levels of authority
(d) Lines of internal and external communication.
It should also address requirements related to competent manpower for
construction activities of the facility. The functional responsibilities of all
the personnel distinguishing task including their assigned administrative
powers should be identified and documented.
The Licensee should formally identify a person to be responsible for
implementation of QA programme during construction activities.
Responsibilities of key personnel in the organisation should be defined in
writing. The person appointed should have the necessary resources to
discharge the following responsibilities:

164
 (a) Ensuring that construction and installation work is carried out in
accordance with design specifications, drawings, procedures and
instructions, including the implementation of specified QA
requirements.
(b) Ensuring that construction and installation work undertaken,
including work by manufacturers/suppliers, is coordinated, conducted
and completed in accordance with planned programmes.
(c) Controlling access to the construction site.
Appropriate controls reflecting safety regulations shall be established for all
personnel, including suppliers and visitors. These shall be in line with
applicable statutes and shall include arrangements for effective planning,
organisation, monitoring and review of the preventive and protective
measures. Management shall provide all necessary support to the contractor
to ensure health and safety of the construction personnel and quality assurance
requirements of construction.
A. 2.1 Grading
A graded approach based on the relative importance to safety of each item,
service or process should be adopted. Activities, which should be graded
during construction include:
(a) Qualification of special construction processes and the personnel to
carry them out
(b) Details and need for inspection plans
(c) Level of traceability of construction material and related records
(d) Level of in-process controls and need for hold points
(e) Complexity involved in equipment handling/ erection and post-
erection preservation
A.2.2 Interfaces
Licensee should ensure that interface arrangements shall be agreed among
the construction agencies, suppliers and other organisational units performing
the work. These should be defined in writing and be included in relevant
documents. Appropriate references of the same should be made in the QA
programme. Handover/ transfer responsibilities after completion of
construction/ installation to operating organisation.
A.3. PERFORMANCE FUNCTIONS
A.3.1 Document Control
Procedures for the preparation, review, approval, issue, modification and
control of documents should be established. The record system should be

165
 established which includes the arrangements and responsibilities for the
categorisation, receipt, indexing, storage, retrieval and disposal of construction
records. Document control system should also include records of as-built
condition of structures, systems and components.
A. 3.2 Procurement Control
Measures shall be established and documented to ensure that relevant
standards/specifications and other requirements necessary to assure adequate
quality are included or referenced for procurement of items and services
required during construction of PARF.
Procurement requirements for assuring quality shall be covered by a
procurement document. The document shall include items such as scope of
work, technical requirements, and test, inspection and acceptance
requirements.
Procedures for the preparation, review, approval, issue, modification and
control of documents pertaining to activities affecting construction should
be established. Document release and distribution system shall be established
utilising up-to-date distribution lists. Individuals responsible for issue of
documents shall be identified.
A.3.3 Supplier Evaluation and Selection
Supplier evaluation shall be carried out to assess the capability to provide
items and services in accordance with the requirements of procurement
document(s). The supplier evaluation includes as appropriate:
(a) evaluation of current technical capability, availability of expertise
and resources,
(b) analysis of product samples, and
(c) review of historical quality performance data.
A.4 PROCESS CONTROL
Documented procedures should be established for all construction related
activities of the PARF such as receiving and storing components, civil
construction, equipment erection, cleaning/flushing, inspection, testing,
modification etc. Provision should be made for verification, review and audit
of activities affecting quality of construction.
Site construction activities should be planned and documented in adequate
detail and approved by designated persons/agencies. The plan shall define:
(a) The planned sequential order and duration of activities
(b) The resource allocation for each activity

166
 (c) Work planning and supervision
(d) Implementation of safety requirement during construction including
fire safety and first aid
Preventive maintenance and preservation of items in stores or installed should
be carried out in accordance with manufacturers’ recommendations and good
engineering practices, and documented.
A.5 VERIFICATION FUNCTIONS
A.5.1 Verification Programme
A comprehensive documented verification programme to be prepared to assure
conformance of construction of the PARF as per the relevant codes and
standards. Verification programme should comprise external (third party) as
well as internal verification at specified stages/periodicity.
A.5.2 Inspection and Test Controls
A plan for inspection and testing of the materials/components used for
construction, should be established. These should include identification of
characteristics to be checked, type of check, acceptance norms etc. These
should specifically include:
(a) Inspection of soil rocks, earthworks and foundation piles
(b) Testing of concrete
(c) Inspection of civil and steel structures
A.5.3 Audit
Provisions need to be prescribed detailing the establishment and
implementation of a comprehensive system of planned and documented audits
to verify the implementation and effectiveness of the various elements of the
quality assurance programme. It should address the audit performance, audit
personnel, audit plan and audit timing etc. The requirement for QA audit and
extent of its application should be based on the safety significance of the
system.
A.6 CORRECTIVE FUNCTIONS
A.6.1 Non-conformity Control and Corrective Actions
A system for the control of non-conformances and their corrective actions
should be established. Non-conformances, deviations or inadequacies
affecting quality should be identified and controlled. The persons responsible
for review and disposition of non-conformances should be identified. The
programme should provide that appropriate action be taken to ensure that

167
 conditions adverse to quality, such as failures, malfunctions, deficiencies,
deviations, defective or incorrect material, equipment and any other non-
conformances are identified, corrected and recurrences are prevented.
A.7 RECORDS
Records should be prepared and maintained to provide objective evidence
of quality to meet the requirements of applicable codes, standards and
specifications to include details such as:
(a) Certificates of each component from the supplier/manufacturer; and
the test and inspection records
(b) Non-conformance reports, corrective/preventive actions carried out
(c) Certificates about raw material such as cement, sand, iron, steel used
during constructions
(d) Records of the test results, acceptance criteria and as-built condition
of structures.
(e) Design reports and drawings
(f) Safety analysis reports
The record system shall be established which includes the arrangements and
responsibilities for the categorization, receipt, indexing, preservation/storage,
retrieval, inspection and disposal of records after expiry of the specified
retention period of non-permanent records.
B. QUALITY ASSURANCE DURING COMMISSIONING AND
OPERATION OF PARF (>10MeV)
Licensee shall develop and implement a QA programme which describes the
overall arrangements for the management, performance and assessment of
the PARF. This programme shall also provide means to ensure that all work
is suitably planned, correctly performed and properly assessed. Procedures
shall be defined by the Employer to ensure that the commissioning and
operation of PARF fulfils specified requirements.
The QAM should be prepared in following format addressing the different
aspects of the facility.
B.1. INTRODUCTION
This section should include Applicability and Scope of the QAM.
B. 2. MANAGEMENT FUNCTIONS
This section should specify the management’s policy statement and
organisation plan. Organisational plan should be documented addressing the
following aspects:

168
 (a) Organisational structure
(b) Functional responsibility
(c) Levels of authority
(d) Lines of internal and external communication.
It should also address requirements related to availability of competent
manpower for commissioning and operation of the facility. The functional
responsibilities of all the personnel distinguishing task including their assigned
administrative powers should be identified and documented. The necessary
resources required by these personnel to discharge the following
responsibilities need to be identified:
(a) Commissioning and operation of the facility is carried out in
accordance with approved procedures, design specifications,
designers’ instructions.
(b) Controlling access to the operating facility.
Procedures need to be documented for formal reviews of QA programme by
management as often as necessary or any changes in the regulatory
requirements that may have been introduced after the previous approval of
QA programmes. Identification and control of compliance with applicable
codes, standards, specification and practices; acceptance criteria (qualitative
and/or quantitative as appropriate) for determining satisfactory completion
of the commissioning and operation activity should be described in the QAM.
B.2.1 Interfaces
The interface arrangements should be agreed with the licensee and various
agencies involved (namely design, construction, commissioning, operation,
decommissioning, AERB and statutory agencies as applicable). Handover/
transfer responsibilities after completion of construction/ installation to
operating organisation.
B.3 PERFORMANCE FUNCTIONS
B.3.1 Document Control
(a) Procedures for the preparation, review, approval, issue, modification
and control of documents pertaining to activities affecting
commissioning and operation should be established.
(b) Document release and distribution system shall be established
utilising up-to-date distribution lists. Individuals responsible for issue
of documents shall be identified.
(c) Documents important for commissioning and operation include,
among others, final safety analysis report (FSAR), acceptance test

169
 report (ATR), and radiation protection manual (RPM),
commissioning reports and technical specifications for operation.
(d) Procedures for making interface with various components and
systems should be prepared. Verification and validation of software
used for operational control should be done by the independent
agencies.
B.3.2 Process Control
B.3.2.1 Commissioning Control
Procedures should be established to ensure that appropriate tests are performed
during commissioning to demonstrate that design intent and, regulatory and
other statutory requirements are met. Satisfactory demonstration of functional
capability of safety systems is a prerequisite for considering the PARF to be
suitable for the operating phase.
Measures shall be established to ensure that all commissioning activities
including beam extraction, transport and dumping are planned, controlled
and implemented in accordance with approved documents such as procedures,
instructions and checklists, and results documented.
Commissioning activities shall commence only after due completion of
respective construction activities supported by certified documents. Inspection
and surveillance shall be performed by the facility and documented to verify
compliance with specification requirements.
Measures shall be established to identify, review, resolve and document all
non-conformances and design changes.
A system for audit of commissioning, follow-up and record of corrective
actions shall be established.
B.3.2.2 Operation Control
Documented procedure shall be established for safe operation of the PARF
in accordance with the design intent and specified operational limits.
Provisions should be included to ensure interface among agencies for
operation, maintenance, technical services, plant management, design,
inspection, testing, verification and audit.
Provision shall exist for regular verification of operation activities related to
safety. Preventive and maintenance schedule should be prepared for all safety
systems as per the applicable codes.
Inspection and testing/surveillance during operation of safety equipment as
well as subsequent to maintenance, modification or procedural changes should
be performed to specified requirements and documented.

170
 Trained and authorised operator should be available for operation of PARF.
Measures should be established to
(i) identify emergency situations and to develop and implement
procedures for coping with emergencies; and
(ii) to hold emergency exercises at specified intervals to identify
inadequacies, if any.
B.4 VERIFICATION FUNCTIONS
B.4.1 Verification Programme
A comprehensive documented verification programme should be prepared
and verification conducted accordingly to assure conformance of
commissioning and operation of the PARF as per the relevant specified codes
and procedures. Verification programme should comprise external as well as
internal verification
B.4.2 Inspection and Test Controls
Measures should be established to ensure that testing and measuring devices
used in determining conformance to acceptance criteria are of proper range,
type, accuracy and precision.
Testing and measuring devices should be controlled, calibrated and adjusted
at specified intervals, or before use, to maintain accuracy within necessary
limits.
Controls shall be established to ensure proper handling, storage and use of
calibrated instruments.
B.4.3 Audit
Provisions need to be prescribed detailing the establishment and
implementation of a comprehensive system of planned and documented audits
to verify the implementation and effectiveness of the various elements of the
quality assurance programme. It should address the audit performance, audit
personnel, audit plan and audit timing etc. The requirement for QA audit and
extent of its application should be based on the safety significance of the
system.
B. 5 CORRECTIVE FUNCTIONS
B.5.1 Non-conformity Control and Corrective Actions
A system for the control of non-conformances and their corrective actions
should be established. Non-conformances, deviations or inadequacies
affecting quality should be identified and controlled. The persons responsible

171
 for review and disposition of non-conformances should be identified. The
programme should provide appropriate actions to be taken to ensure that
conditions adverse to quality, such as failures, malfunctions, deficiencies,
deviations, defective or incorrect material, equipment and any other non-
conformance are identified and corrected.
Preventive actions should also be identified based on the review of non-
conformances.
B.6 RECORDS
Records should be prepared and maintained to provide objective evidence
of quality to meet the requirements of applicable codes, standards and
specifications.
Records should include:
(a) results of reviews, inspections, tests and audits,
(b) operation logs,
(c) non-conformance reports, repairs carried out,
(d) training, qualifications and certification of personnel,
(e) information pertaining to ‘as built’ condition of items in the plant,
(f) copies of design drawings, PSAR, FSAR, RPM, QAM, licence/
consents/certificates, etc.,
(g) radiation dose records, emergency exercises and maintenance
records.
The record system shall be established which includes the arrangements and
responsibilities for the categorisation, receipt, indexing, preservation/storage,
retrieval, inspection and disposal of records after expiry of the specified
retention period of non-permanent records.

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 (APPENDICES 5B,5D, 5E, 5F REFER TO MEDICAL
CYCLOTRON FACILITY)

APPENDIX-5B
(Refer section 3.4.1.3)

FORMAT OF THE PRELIMINARY SAFETY ANALYSIS REPORT (PSAR)

FOR MEDICAL CYCLOTRON FACILITIES

[PSAR should be submitted to AERB in this format, duly signed by Head of

the organisation (employer) along with the application for the layout and
construction approval of Medical Cyclotron Facility]

INTRODUCTORY INFORMATION

1. Name and address of the applicant :

Institution profile :
Purpose and scope of the project :
2. Details of Supplier :
Name and address of the applicant/local
supplier with PIN code (in block letters) :
3. Details of System Parameters
Model/Type designation of the medical
cyclotron :
Year and country of manufacture :
Type of the medical cyclotron
(shielded/non self- shielded) :
Maximum beam energy : MeV
Maximum beam current : μA
Number of targets :
Operational life of the device (in hours) :
Radiation levels at a distance
of one metre from the cyclotron
under beam ‘ON’ condition (specify
for maximum energy and mode) :
(Please attach dose contours around
the cyclotron and cyclotron vault)

173
 Leakage radiation and other parameters .... :
Built-in safety features/operation
procedures to prevent any radiologically
unsafe malfunction of the equipment :
(Please attach relevant documents such
as installation manual, operation/
servicing manual)
Specify the standards to which the
medical cyclotron comply :
Details of beam energy and current
calibration facility :
4. Number of Synthesis and Dispensing Units :
5. Design Manual of the Medical Cyclotron which includes
(a) Drawing and functional description of the accelerating chamber and
target systems along with radiation shielding
(b) Drawings along with the functional description of safety related
control systems and devices
(c) National standards to which the equipment conforms (English
translation of the Standard is to be provided)
(d) Test report on performance of the medical cyclotron demonstrating
the compliance with the National standard
(e) Certificate from the competent authority of country of design/
manufacture to the effect that the equipment is approved for isotope
production use
6. Layout of the Medical Cyclotron Vault and Associated Facilities, Indicating
the following details
(a) Radiation shielding details : Concrete blocks, earth beams (barrier
or insulation), lead bricks, iron plates etc.
(b) Barriers : Fences, locked gates, doors etc.
(c) Facility specific : Control console facility to view active and passive
engineered controls
(d) Area radiation monitors
(e) Ventilation facility
(f) Caution and alert system
(g) Access sensors or interlocks : Electrical, magnetic and mechanical

174
 (h) ‘Crash’ or ‘Scram’ buttons either mounted on walls or at doors and
gates
(i) Search and rescue control
(j) Warning indicators (status lights, alarms, posted procedures)

7. Details of Documents with Details (to be submitted)

Design detail : Summary of medical cyclotron design and general
working principles, specifications and physical
parameters of the system and user objectives.
Site characteristics : Location, occupancy in site area as well as
surrounding population up to 30 meters radius,
geology, load bearing capacity of soil and rock,
structural design criteria, foundation, meteorology,
seismology, water table, flood level, plinth level
(with respect to nearest accessible road), AERB
site approval reference, etc.
Medical cyclotron : Description of general layout, details of buildings,
pressure vessels, vacuum system, radio frequency
system, magnetic field, beam injection, acce-
leration, transport and target system including their
design, construction and testing and quality
assurance manual for the equipment.
Synthesis and : Name and address of the Manufacturer and
dispensing units supplier, make and model of the synthesis and
dispensing unit, maximum activity to be handled,
material and thickness of shielding.
Biological shield - Final sketch giving details of shielding wall
surrounding the source, wall thickness, labyrinth
access, openings, voids, reinforcements,
embedment etc. in the biological shield. Method
of shielding calculation and the dose limits
followed
- Shield material, density, and quality control
measures followed during shield construction
- Maximum and minimum shield thickness, roof
thickness
- Drawings and layout of the device location
installed

175
 - Dose rate profiles anticipated at various locations:
(maximum and minimum values). Indicate them
on a sketch of the facility - control room, roof,
access doors, openings and where personnel are
expected to be stationed for work or otherwise.
- Radiation shielding evaluation including sky shine
- Maximum dose rate anticipated
Locations: (Indicate also in a sketch)
8. Documentation Details of Auxiliary Services
(a) Electrical power and power supply systems (including emergency
power supply), major electrical equipment, illumination, lift, hoist,
cranes etc.
(b) Air conditioning and ventilation system (including treatment of
noxious gases produced, if any)
(c) Cooling water supply system
(d) Compressed air system
(e) Communication system
(f) Target gas handling system - system description, characteristics of
the gas (properties, specifications, purification etc.)
(g) Laboratory, workshops, stores, etc.
(h) Other services- please specify.
(i) Controls of various subsystems, description, operation etc.
9. List of Potential Hazards and Safety Measures to be taken
(a) During precommissioning trials of all systems and subsystems
(b) During commissioning
(c) During operation and maintenance
10. Safety Features Including Hazard Evaluation
(a) Design safety of buildings and equipment
(b) Structural design: Seismic and wind load parameter details
(c) Accelerator facility
(d) Electrical system and equipment
(i) Power and control cables-specifications
(ii) Cable ducting

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 (iii) Safety fencing of high voltage locations
(iv) Earthing
(v) Electromagnetic interference and suppression
(e) Air conditioning and ventilation
(f) Vacuum system
(g) Cooling water supply system
(h) Compressed air system
(i) Dry nitrogen supply system
(j) Communication system
(k) Control system
(l) Fail safe (any defect or component failure, which prevents the
cyclotron operation) and operational independent
(m) Inventory and labeling of control devices
(n) Others, please specify.
11. Radiation Safety
(a) Radiation safety policy
(b) Dose equivalent limits
(c) Planned exposure (operational hours/week)
(d) Planned special exposure
(e) Design features - shielding etc.
(f) Radiation monitoring and alarm system (including interlocks)
(g) Induced activity estimation - radiation levels due to induced activity,
induced gaseous airborne activity (if applicable)
(h) Radiation sensitive components installed inside the facility and their
durability
(i) Induced activity in cooling water
(j) Other radiation safety considerations - radioactive waste, postulation
of radiation accident (target rupture, loss of shielding integrity),
analysis and action, administrative considerations (if applicable)
(k) Analysis of potential radiation exposure scenarios
12. Chemical Safety
List of chemicals used with quantities, their toxicity and hazards, safety
considerations, analysis of potential release scenarios and preventive and

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 other action to be taken (e.g. Ozone production and ozone depleting substance,
flammable gases, liquids, oxygen deficiency hazard (SF6), biologically
hazardous material, cryogenic fluids, etc.)
13. Fire Safety
Fire and explosion hazards, means of escape, access, fire detection and alarm
system, fire fighting system-fire hydrants, dry risers, fire extinguishers etc.
14. Personnel Safety
Safety policy, organisation, functions of safety personnel, responsibilities,
general safety rules, accident prevention program, safety equipment and
procurement, safety inspection, housekeeping, accident reporting,
investigation, preventive measures, training, medical facilities including first
aid.
15. Safety in Operation and Maintenance
(i) Startup procedure
(ii) Shutdown procedure
(iii) Emergency shutdown procedure
(iv) Search and secure
(v) Procedure for entry into cyclotron vault
(vi) Others (eg. gas handling procedure), please specify
16. Emergency Planning and Procedures
(types of emergencies envisaged, preventive measures, handling of
emergencies, investigation etc.)
(i) During major leaks, foil rupture, contamination, target rupture, loss
of shielding integrity
(ii) During explosion and fire
(iii) During general fires
(iv) During emergency in tanks and equipment etc.
(v) During radiation emergency
(vi) Crisis management in case of major emergency
17. Pre-operational Radiation Survey Report (background radiation in and vicinity
of the medical cyclotron facility)
18. Quality Assurance Manual for Construction of the Facility (as per format
given in item A of Appendix-6A of AERB/RF/SG/G-3)

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19. Details of waste disposal pocedures and provisions including adequate
financial arrangement for safe disposal of spent/ disused sources.
20. Details of storage facility for activated components and procedure (identifying
long half life radioisotopes)
21. Details to be furnished regarding the decommissioning of the facility.

We certify that all the information provided by us is true and correct to the best of our
knowledge and belief.

Place: Signature:
Date: Name:
Designation:

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 APPENDIX-5D
(Refer section 3.4.1.4)

FORMAT OF THE FINAL SAFETY ANALYSIS REPORT (FSAR) FOR

MEDICAL CYCLOTRON FACILITIES

[FSAR should be submitted to AERB in this format, duly signed by Head of the
organisation (employer) along with the application for the commissioning and operation
of Medical Cyclotron Facility]
A. INTRODUCTORY INFORMATION
1. Name and address of the applicant :
Head of Institution :
2. Institution profile :
3. Purpose and scope of the project :
4. Details of Supplier :
Name and address of the applicant/local
supplier with PIN code (in block letters) :
5. Details of AERB Site Approval
Ref. No. :
Date of issue :
Valid up to :
6. Details of AERB Layout and Construction
Approval
Ref. No. :
Date of issue :
Valid up to :
7. Detail of System Parameters :
Model/Type designation of
the medical cyclotron :
Year and country of manufacture :
Type of the medical cyclotron
(shielded/non shielded) :
Maximum beam energy - : MeV
Maximum beam current - : μA
Number of targets - :

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 Operational life of the device (in hours) :
Radiation levels at a distance
of one metre from the cyclotron
under beam ‘ON’ condition (specify for
maximum energy and mode) :
(Please attach dose contours around
the cyclotron and cyclotron vault )
Leakage radiation and other parameters .... :
Built-in safety features/operation
procedures to prevent any radiologically
unsafe malfunction of the equipment :
(Please attach relevant documents such
as installation manual, operation/servicing
manual)
Specify the standards to which the
medical cyclotron comply :
Details of beam energy and
current calibration facility :
Number of synthesis and dispensing units :
8. Design Manual of the Medical Cyclotron which includes
(a) Drawing and functional description of the accelerating chamber and
target systems along with radiation shielding
(b) Drawings along with the functional description of safety related
control systems and devices
(c) National standards to which the equipment conforms (English
translation of the Standard is to be provided)
(d) Test report on performance of the medical cyclotron demonstrating
the compliance with the National standard
(e) Certificate from the competent authority of country of design/
manufacture to the effect that the equipment is approved for isotope
production use
9. Layout of the Medical Cyclotron Vault and Associated Facilities, indicating
the following details
(a) Radiation shielding details : concrete blocks, earth beams (barrier
or insulation), lead bricks, iron plates etc.
(b) Barriers: fences, locked gates, doors etc.

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 (c) Facility specific : Control console facility to view active and passive
engineered controls
(d) Area radiation monitors
(e) Ventilation facility
(f) Caution and alert system
(g) Access sensors or interlocks: Electrical, magnetic and mechanical
(h) ‘Crash’ or ‘Scram’ buttons either mounted on walls or at doors and
gates
(i) Search and rescue control
(j) Warning indicators (status lights, alarms, posted procedures)
10. Details of Documents with Details (to be submitted)
Design detail : Summary of medical cyclotron design and general
working principles, specifications and physical
parameters of the system and user objectives.
Site characteristics : Location, occupancy in site area as well as sur-
rounding population up to 30 meters radius,
geology, load bearing capacity of soil and rock,
structural design criteria, foundation, meteorology,
seismology, Water table, flood level, plinth level
(with respect to nearest accessible road), AERB
site approval reference, etc.
Medical cyclotron : Description of general layout, details of buildings,
pressure vessels, vacuum system, Radio frequency
system, Magnetic field, beam injection, accele-
ration, transport and target system including their
design, construction and testing and quality
assurance manual for the equipment.
Synthesis and : Name and address of the manufacturer and
dispensing units supplier, make and model of the synthesis and
dispensing unit, maximum activity to be handled,
material and thickness of shielding.
Biological shield - Final sketch giving details of shielding wall
surrounding the source, wall thickness, labyrinth
access, openings, voids, reinforcements, embed-
ment etc. in the biological shield. Method of
shielding calculation and the dose limits followed

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 - Shield material, density, and quality control
measures followed during shield construction
- Maximum and minimum shield thickness, roof
thickness
- Drawings and layout of the device location
installed
- Dose rate profiles anticipated at various locations:
(Maximum and minimum values). Indicate them
on a sketch of the facility - control room, roof,
access doors, openings and where personnel are
expected to be stationed for work or otherwise.
- Radiation shielding evaluation including sky shine
- Maximum dose rate anticipated
Locations : (indicate also in a sketch)
11. Documentation Details of Auxiliary Services
(a) Electrical power and power supply systems (including emergency
power supply), major electrical equipment, illumination, lift, hoist,
cranes etc.
(b) Air conditioning and ventilation system (including treatment of
noxious gases produced, if any)
(c) Cooling water supply system
(d) Compressed air system
(e) Communication system
(f) Target gas handling system - system description, characteristics of
the gas (properties, specifications, purification etc.)
(g) Laboratory, workshops, stores, etc.
(h) Other services (please specify)
(i) Controls of various subsystems, description, operation etc.
12. List of Potential Hazards and Safety Measures to be Taken
(a) During precommissioning trials of all systems and subsystems
(b) During commissioning
(c) During operation and maintenance
13. Safety Features Including Hazard Evaluation
(a) Design safety of buildings and equipment

183
 (b) Structural design: Seismic and wind load parameter details
(c) Accelerator facility
(d) Electrical system and equipment
(i) Power and control cables-specifications
(ii) Cable ducting
(iii) Safety fencing of high voltage locations
(iv) Earthing
(v) Electromagnetic interference and suppression
(e) Air conditioning and ventilation
(f) Vacuum system
(g) Cooling water supply system
(h) Compressed air system
(i) Dry nitrogen supply system
(j) Communication system
(k) Control system
(l) Fail safe (any defect or component failure, which prevents the
cyclotron operation) and operational independent
(m) Inventory and labeling of control devices
(n) Others, Please specify.
14. Radiation Safety
(a) Radiation safety policy
(b) Dose equivalent limits
(c) Planned exposure (operational hours/week)
(d) Planned special exposure
(e) Design features - shielding etc.
(f) Radiation monitoring and alarm system (including interlocks)
(g) Induced activity estimation - radiation levels due to induced activity,
induced gaseous airborne activity (if applicable)
(h) Radiation sensitive components installed inside the facility and their
durability
(i) Induced activity in cooling water
(j) Other radiation safety considerations - radioactive waste, postulation
of radiation accident (target rupture, loss of shielding integrity),
analysis and action, administrative considerations (if applicable)

184
 (k) Analysis of potential radiation exposure scenarios
15. Chemical Safety
List of chemicals used with quantities, their toxicity and hazards, safety
considerations, analysis of potential release scenarios and preventive and
other action to be taken [e.g. ozone production and ozone depleting substance,
flammable gases, liquids, oxygen deficiency hazard (SF6), biologically
hazardous material, cryogenic fluids, etc.]
16. Fire Safety
Fire and explosion hazards, means of escape, access, fire detection and alarm
system, fire fighting system- fire hydrants, dry risers, fire extinguishers etc.
17. Personnel Safety
Safety policy, organisation, functions of safety personnel, responsibilities,
general safety rules, accident prevention program, safety equipment and
procurement, safety inspection, housekeeping, accident reporting,
investigation, preventive measures, training, medical facilities including first
aid.
18. Safety in Operation and Maintenance
(i) Startup procedure
(ii) Shutdown procedure
(iii) Emergency shutdown procedure
(iv) Search and secure
(v) Procedure for entry into cyclotron vault
(vi) Others (eg. gas handling procedure), please specify.
19. Emergency Planning and Procedures
(types of emergencies envisaged, preventive measures, handling of
emergencies, investigation etc.)
(i) During major leaks, foil rupture, contamination, target rupture, loss
of shielding integrity
(ii) During explosion and fire
(iii) During general fires
(iv) During emergency in tanks and equipment etc.
(v) During radiation emergency
(vi) Crisis management in case of major emergency

185
20. Pre-operational radiation survey report (background radiation in and vicinity
of the medical cyclotron facility)
21. Quality assurance manual for construction of the facility (as per format given
in item A of Appendix 6A of AERB/RF/SG/G-3)
22. Details of waste disposal pocedures and provisions including adequate
financial arrangement for safe disposal of spent/ disused sources.
23. Details of storage facility for activated components and procedure (identifying
long half life radioisotopes)
24. Details to be furnished regarding the decommissioning of the facility.
B. OPERATING AND SAFETY PERSONNEL
(i) Cyclotron operator :
(ii) Radiopharmacist :
(iii) Radiological safety officer :
AERB Approval Ref. :
Date of issue :
Valid up to :

DETAILS OF DOCUMENTS TO BE SUBMITTED

Required documents
Technical description of medical cyclotron design and working procedure with
drawings
Electrical circuit diagram and other interlocks of the medical cyclotron device
(inbuilt safety features)
Electrical circuit diagram and other interlocks of the medical cyclotron vault
Calibration and periodic checks
Provisions and procedures for (particle beam energy, beam current)
Quality assurance manual (operation)
Arrangements for personal and environmental monitoring system
Periodic surveys of radioactive contamination if applicable
Availability of local safety committee and their safety evaluation report
Details of deviations from approved medical cyclotron components, medical
cyclotron vault, shielding design, etc.
Decommissioning procedures of the medical cyclotron facility

186
We certify that all the information provided by us is true and correct to the best of our
knowledge and belief.

Place: Signature:
Date: Name:
Designation:

Encl : Documents attached as per the above requirement

187
 APPENDIX-5E
(Refer section 3.4.1.4)

RADIATION PROTECTION MANUAL FOR MEDICAL

CYCLOTRON FACILITY

(OPERATION, MAINTENANCE, EMERGENCY ASPECTS)

A. ADMINISTRATION AND SAFETY ASSURANCE

(a) Administrative hierarchy/organisational set up
(b) Authorised personnel - Training and qualification of facility
personnel, their knowledge in radiation
safety, responsibilities of each of
personnel, their availability in adequate
number, policies in case of long leave/
absence of certified personnel
(c) Local safety committee: constitution, functions and responsibilities
(d) Procedures for reporting to the regulatory agency on unusual
occurrences and periodic radiation safety status
(e) Procedures in case of change or repairs of H.V. system, safety system/
interlocks, certification of log book entry by RSO
(f) Records of maintenance - maintenance schedule, radiation
monitoring, and calibration of survey meters, etc.
(g) Industrial safety aspects - fire equipment, safety accessories etc.
(h) Facility security arrangements, fencing and personnel movement
control etc.
(i) Removal and storage of contaminated material, if any.
(j) Medical assistance - first aid facility, location, periodic medical
examination (once a year), medical facilities and treatment facilities
for radiation incidents
B. MONITORING
(a) Radiation monitoring - Type of area monitors, sensitivity
range, location, interlock alarm set
levels

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 (b) Contamination monitoring - On line monitoring and sample
measurement, method of collecting
samples
(c) Personnel monitoring - Number of PM badges, procedure
for their issuance, safe place for
storage, etc.
C. OPERATION PROCEDURES
‘Beam ON’ procedures be established, documented and displayed in the
console area
D. MAINTENANCE PROCEDURE FOR SAFETY SYSTEMS/
INTERLOCKS
(a) Periodic maintenance - Daily/weekly/monthly/quarterly/
yearly (items, procedures and
schedules)
(b) Procedure for maintenance of cooing water used for cooling target
beam line components, etc
(c) Procedure for maintenance of air cooling mechanism, maintenance
and checking of alarm/ warning devices
E. EMERGENCY PLANNING AND PROCEDURES
(a) Organisational structure and communication links
(b) Name, address and telephone numbers of agencies to be contacted
in case of emergency
(c) Emergency contact telephone/ telex nos. and address of
(i) Head of Institution
(ii) Facility-in-charge
(iii) Radiological safety officer (RSO)
(iv) Regulatory agency (AERB)
(v) Fire safety officer (Local)
(vi) Local fire station
(vii) Local police station
(viii) Local medical hospital, radiation therapy hospitals (nearest)
(d) Type of emergencies envisaged - Prevention/handling of emergencies,
investigation methods, etc. during major leaks of water, explosion
or fire or smoke, radiation emergency, crisis management in case of
emergency, earthquake, floods, other natural calamities.

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 APPENDIX-5F
(Refer section 3.4.1.3, 3.4.1.4)

QUALITY ASSURANCE MANUAL (QAM) FOR MEDICAL

CYCLOTRON FACILITIES

A. QUALITY ASSURANCE PROGRAMME DURING CONSTRUCTION

OF MEDICAL CYCLOTRON FACILITIES
The Employer/Licensee shall develop and implement a QA programme which
describes the overall arrangements for the management, performance and
assessment of structures/systems/components related to civil, mechanical,
electrical and instrumentation aspects of medical cyclotron facilities during
construction. This programme should specify the means to ensure that all
work is suitably planned, correctly performed and properly assessed in order
to implement design intent in the construction.
The QA manual (QAM) should be prepared addressing the following aspects:
A.1 INTRODUCTION
This section should include applicability and scope of the QAM.
A.2 MANAGEMENT FUNCTIONS
This section should specify the management’s policy statement and
organisational plan. Organisational plan should be documented addressing
the following aspects:
(a) Organisational structure
(b) Functional responsibility
(c) Levels of authority
(d) Lines of internal and external communication.
It should also address requirements related to competent manpower for
construction activities of the facility. The functional responsibilities of all
the personnel distinguishing task including their assigned administrative
powers should be identified and documented.
The Licensee should formally identify a person to be responsible for
implementation of QA programme during construction activities.
Responsibilities of key personnel in the organisation should be defined in
writing. The person appointed should have the necessary resources to
discharge the following responsibilities:

190
 (a) Ensuring that construction and installation work is carried out in
accordance with design specifications, drawings, procedures and
instructions, including the implementation of specified QA
requirements.
(b) Ensuring that construction and installation work undertaken,
including work by manufacturers/suppliers, is coordinated, conducted
and completed in accordance with planned programmes.
(c) Controlling access to the construction site.
Appropriate controls reflecting safety regulations shall be established for all
personnel, including suppliers and visitors. These shall be in line with
applicable statutes and shall include arrangements for effective planning,
organisation, monitoring and review of the preventive and protective
measures. Management shall provide all necessary support to the contractor
to ensure health and safety of the construction personnel and quality assurance
requirements of construction.
A.2.1 Grading
A graded approach based on the relative importance to safety of each item,
service or process should be adopted. Activities, which should be graded
during construction include:
(a) Qualification of special construction processes and the personnel to
carry them out
(b) Details and need for inspection plans
(c) Level of traceability of construction material and related records
(d) Level of in-process controls and need for hold points
(e) Complexity involved in equipment handling/erection and post-
erection preservation.
A.2.2 Interfaces
Employer/Licensee should ensure that interface arrangements shall be agreed
among the construction agencies, suppliers and other organisational units
performing the work. These should be defined in writing and be included in
relevant documents. Appropriate references of the same should be made in
the QA programme. Handover/transfer responsibilities after completion of
construction/installation to operating organisation.
A.3. PERFORMANCE FUNCTIONS
A.3.1 Document Control
Procedures for the preparation, review, approval, issue, modification and

191
 control of documents should be established. The record system should be
established which includes the arrangements and responsibilities for the
categorisation, receipt, indexing, storage, retrieval and disposal of construction
records. Document control system should also include records of as-built
condition of structures, systems and components.
A.3.2 Procurement Control
Measures shall be established and documented to ensure that relevant
standards/specifications and other requirements necessary to assure adequate
quality are included or referenced for procurement of items and services
required during construction of medical cyclotron facilities.
Procurement requirements for assuring quality shall be covered by a
procurement document. The document shall include items such as scope of
work, technical requirements, and test, inspection and acceptance
requirements.
Procedures for the preparation, review, approval, issue, modification and
control of documents pertaining to activities affecting construction should
be established. Document release and distribution system shall be established
utilising up-to-date distribution lists. Individuals responsible for issue of
documents shall be identified. Records important for construction include
PSAR, civil structure design documents etc.
A.3.3 Supplier Evaluation and Selection
Supplier evaluation shall be carried out to assess the capability to provide
items and services in accordance with the requirements of procurement
document(s). The supplier evaluation includes as appropriate:
(a) evaluation of current technical capability, availability of expertise
and resources,
(b) analysis of product samples, and
(c) review of historical quality performance data.
A.4 PROCESS CONTROL
Documented procedures should be established for all construction related
activities of the medical cyclotron facilites such as receiving and storing
components, civil construction, equipment erection, cleaning/flushing,
inspection, testing, modification etc. Provision should be made for verification,
review and audit of activities affecting quality of construction.
Site construction activities should be planned and documented in adequate
detail and approved by designated persons/agencies. The plan shall define:

192
 (a) The planned sequential order and duration of activities
(b) The resource allocation for each activity
(c) Work planning and supervision
(d) Implementation of safety requirement during construction including
fire safety and first aid
Preventive maintenance and preservation of items in stores or installed should
be carried out in accordance with manufacturers’ recommendations and good
engineering practices, and documented.
A.5 VERIFICATION FUNCTIONS
A.5.1 Verification Programme
A comprehensive documented verification programme to be prepared to assure
conformance of construction of the medical cyclotron facilities as per the
relevant codes and standards. Verification programme should comprise
external (third party) as well as internal verification at specified stages/
periodicity.
A.5.2 Inspection and Test Controls
A plan for inspection and testing of the materials/components used for
construction, should be established. These should include identification of
characteristics to be checked, type of check, acceptance norms etc. These
should specifically include identification of characteristics to be checked,
type of check, acceptance norms etc. Provisions to test construction
equipment, calibration of testing and measuring instruments etc. prior to their
use need to be established.
A.5.3 Audit
Provisions need to be prescribed detailing the establishment and
implementation of a comprehensive system of planned and documented audits
to verify the implementation and effectiveness of the various elements of the
quality assurance programme. It should address the audit performance, audit
personnel, audit plan and audit timing etc. The requirement for QA audit and
extent of its application should be based on the safety significance of the
system.
A.6. CORRECTIVE FUNCTIONS
A.6.1 Non-conformity Control and Corrective actions
A system for the control of non-conformances and their corrective actions
should be established. Non-conformances, deviations or inadequacies
affecting quality should be identified and controlled. The persons responsible

193
 for review and disposition of non-conformances should be identified. The
programme should provide that appropriate action be taken to ensure that
conditions adverse to quality, such as failures, malfunctions, deficiencies,
deviations, defective or incorrect material, equipment and any other non-
conformances are identified, corrected and recurrences are prevented.
A.7. RECORDS
Records should be prepared and maintained to provide objective evidence
of quality to meet the requirements of applicable codes, standards and
specifications to include details such as:
(a) Certificates of each component from the supplier/manufacturer; and
the test and inspection records
(b) Non-conformance reports, corrective/preventive actions carried out
(c) Certificates about raw material such as cement, sand, iron, steel used
during constructions
(d) Records of the test results, acceptance criteria and as-built condition
of structures.
(e) Design reports and drawings
(f) Safety analysis reports
The record system shall be established which includes the arrangements and
responsibilities for the categorisation, receipt, indexing, preservation/storage,
retrieval, inspection and disposal of records after expiry of the specified
retention period of non-permanent records.
B. QUALITY ASSURANCE DURING COMMISSIONING AND
OPERATION OF MEDICAL CYCLOTRON
Employer/Licensee shall develop and implement a QA programme which
describes the overall arrangements for the management, performance and
assessment of the medical cyclotron facilites. This programme shall also
provide means to ensure that all work is suitably planned, correctly performed
and properly assessed. Procedures shall be defined by the Employer to ensure
that the commissioning and operation of medical cyclotron facilites fulfils
specified requirements.
The QAM should be prepared in following format addressing the different
aspects of the facility.
B.1. INTRODUCTION
This section should include Applicability and Scope of the QAM.

194
B.2. MANAGEMENT FUNCTIONS
This section should specify the management’s policy statement and
organisation plan. Organisational plan should be documented addressing the
following aspects:
(a) Organisational structure
(b) Functional responsibility
(c) Levels of authority
(d) Lines of internal and external communication.
It should also address requirements related to availability of competent
manpower for commissioning and operation of the facility. The functional
responsibilities of all the personnel distinguishing task including their assigned
administrative powers should be identified and documented. The necessary
resources required by these personnel to discharge the following
responsibilities need to be identified:
(a) Commissioning and operation of the facility is carried out in
accordance with approved procedures, design specifications,
designers’ instructions.
(b) Controlling access to the operating facility.
Procedures need to be documented for formal reviews of QA programme by
management as often as necessary or any changes in the regulatory
requirements that may have been introduced after the previous approval of
QA programmes. Identification and control of compliance with applicable
codes, standards, specification and practices; acceptance criteria (qualitative
and/or quantitative as appropriate) for determining satisfactory completion
of the commissioning and operation activity should be described in the QAM.
B.2.1 Interfaces
The interface arrangements should be agreed with the licensee and various
agencies involved (namely design, construction, commissioning, operation,
decommissioning, AERB and statutory agencies as applicable). Handover/
transfer responsibilities after completion of construction/ installation to
operating organisation.
B.3 PERFORMANCE FUNCTIONS
B.3.1 Document Control
(a) Procedures for the preparation, review, approval, issue, modification
and control of documents pertaining to activities affecting
commissioning and operation should be established.

195
 (b) Document release and distribution system shall be established
utilising up-to-date distribution lists. Individuals responsible for issue
of documents shall be identified.
(c) Documents important for commissioning and operation include
among others, final safety analysis report (FSAR), acceptance test
report (ATR), and radiation protection manual (RPM), commi-
ssioning reports and technical specifications for operation.
(d) Procedures for making interface with various components and
systems should be prepared. Verification and validation of software
used for operational control should be done by the independent
agencies.
B.3.2 Process Control
B.3.2.1 Commissioning Control
Procedures should be established to ensure that appropriate tests are performed
during commissioning to demonstrate that design intent and, regulatory and
other statutory requirements are met. Satisfactory demonstration of functional
capability of safety systems is a prerequisite for considering the medical
cyclotron facilites to be suitable for the operating phase.
Measures shall be established to ensure that all commissioning activities
including beam extraction, transport and dumping are planned, controlled
and implemented in accordance with approved documents such as procedures,
instructions and checklists, and results documented.
Commissioning activities shall commence only after due completion of
respective construction activities supported by certified documents. Inspection
and surveillance shall be performed by the facility and documented to verify
compliance with specification requirements.
Measures shall be established to identify, review, resolve and document all
non-conformances and design changes.
A system for audit of commissioning, follow-up and record of corrective
actions shall be established.
B.3.2.2 Operation Control
Documented procedure shall be established for safe operation of the medical
cyclotron facilites in accordance with the design intent and specified
operational limits.
Provisions should be included to ensure interface among agencies for
operation, maintenance, technical services, plant management, design,
inspection, testing, verification and audit.

196
 Provision shall exist for regular verification of operation activities related to
safety. Preventive and maintenance schedule should be prepared for all safety
systems as per the applicable codes.
Inspection and testing/surveillance during operation of safety equipment as
well as subsequent to maintenance, modification or procedural changes should
be performed to specified requirements and documented.
B.4 VERIFICATION FUNCTIONS
B.4.1 Verification Programme
A comprehensive documented verification programme should be prepared
and verification conducted accordingly to assure conformance of
commissioning and operation of the medical cyclotron facilites as per the
relevant specified codes and procedures. Verification programme should
comprise external as well as internal verification
B.4.2 Inspection and Test Controls
Measures should be established to ensure that testing and measuring devices
(e.g. radiation survey meters, area monitors, tools, gauges and other devices)
used in determining conformance to acceptance criteria are of proper range,
type, accuracy and precision.
Testing and measuring devices should be controlled, calibrated and adjusted
at specified intervals, or before use, to maintain accuracy within necessary
limits.
Controls shall be established to ensure proper handling, storage and use of
calibrated instruments.
B.4.3 Audit
Provisions need to be prescribed detailing the establishment and
implementation of a comprehensive system of planned and documented audits
to verify the implementation and effectiveness of the various elements of the
quality assurance programme. It should address the audit performance, audit
personnel, audit plan and audit timing etc. The requirement for QA audit and
extent of its application should be based on the safety significance of the
system.
B.5 CORRECTIVE FUNCTIONS
B.5.1 Non-conformity Control and Corrective Actions
A system for the control of non-conformances and their corrective actions
should be established. Non-conformances, deviations or inadequacies
affecting quality should be identified and controlled. The persons responsible

197
 for review and disposition of non-conformances should be identified. The
programme should provide appropriate actions to be taken to ensure that
conditions adverse to quality, such as failures, malfunctions, deficiencies,
deviations, defective or incorrect material, equipment and any other non-
conformance are identified and corrected.
Preventive actions should also be identified based on the review of non-
conformances.
B.6 QA RECORDS
Records should be prepared and maintained to provide objective evidence
of quality to meet the requirements of applicable codes, standards and
specifications.
Records should include:
(a) results of reviews, inspections, tests and audits,
(b) operation logs,
(c) non-conformance reports, repairs carried out,
(d) training, qualifications and certification of personnel,
(e) information pertaining to ‘as-built’ condition of items in the plant,
(f) copies of design drawings, PSAR, FSAR, RPM, QAM, licence/
consents/certificates, etc.,
(g) radiation dose records, emergency exercises and maintenance
records.
The record system shall be established which includes the arrangements and
responsibilities for the categorisation, receipt, indexing, preservation/storage,
retrieval, inspection and disposal of records after expiry of the specified
retention period of non-permanent records.

198
 (APPENDICES 6A.6B,6D, 6E, 6F ARE FOR IFRT)

APPENDIX-6A
(Refer section 3.4.3.2)

FORMAT FOR SITE ASSESSMENT REPORT OF INTEGRATED

FACILITY FOR RADIATION TECHNOLOGY (IFRT)

GEOLOGICAL AND GEOTECHNICAL INVESTIGATIONS

1. Site investigations for Integrated Facility for Radiation Technology are

necessary to determine the geotechnical characteristics of the site that affect
the design, performance and safety of the IFRT. The investigations should
produce the information needed to define the overall site geology to a degree
that is necessary for an understanding of the subsurface conditions in order
to ensure stability against natural hazards like earthquake, flood etc.
2. Site investigations should also provide information needed to define ground
water conditions as well as the geotechnical parameters needed for analysis
and design of foundations. These include parameters to evaluate the subsurface
characteristics for safe engineering of IFRT, such as bearing capacity of
foundation material, lateral earth pressure, the stability of cuts and slopes in
rock, the effects of earthquake induced motions transmitted through underlying
deposits on the response of soils and structure (including the potential for
inducing liquefaction in soils) and also those needed to estimate the expected
settlement of the structure.
3. Requirements of geotechnical investigations depend on the site specific
conditions. However, the following investigations are the minimum, which
should be carried out for the evaluation of parameters required for safe design:
(a) Field Work
(i) Drilling of bore holes
(ii) Collection of disturbed/undisturbed soil and water samples
(iii) Standard penetration tests
(iv) Plate load tests
(v) Electrical receptivity tests
(b) Laboratory Tests on Soil Samples
(i) Grain size analysis (Coarse and fine)
(ii) Consistency limit test

199
 (iii) Specific gravity of soil
(iv) Proctor density test
(v) Permeability test
(vi) Consolidation test
(vii) Modulus of elasticity and poisons ratio
(viii) Unconfined/confined compression test
(ix) Direct shear test (consolidated drained)
(x) Chemical tests on soil
(c) Laboratory Tests on Rock Samples
(i) Petrographic study
(ii) Porosity
(iii) Unconfined/confined compression test
(iv) Modulus of elasticity and poisons ratio
(d) Test on Ground Water Samples
Chemical analysis of ground water sample
4. Following requisites should be met in connection with geotechnical
investigations:
(i) Prior to commencement of geotechnical investigation, a
comprehensive plan of the work should be chalked out. Geological
status of the site should be examined based on available information.
Additional investigation may be required if site specific conditions
warranted so for the safety of the plant.
(ii) Minimum depth of boreholes should be three times the larger
dimension of the footing.
(iii) Number of boreholes should be such that subsurface profile of the
plant area can be drawn with reasonable certainty in any direction.
At least four data points should be available, in any direction, for
plotting of sub surface profile.
(iv) Geological mapping of the foundation pit should be carried out after
completion of excavation.
(v) Appropriate rectification/stabilisation measures shall be adopted if
it is found necessary after excavation.

200
4.1 Report on geotechnical investigation with the following details:
(i) Geological status of the site based on available information
(ii) Details of bore logs and trial pit logs
(iii) Permeability test results
(iv) Ground water observations
(v) Results of soil and rock tests
(vi) Chemical test results of water
(vii) Sub surface profiles
(viii) Electrical resistivity logging
(ix) Petrographic study results
(x) Evaluation of foundation design parameters

201
 APPENDIX-6B
(Refer section 3.4.3.3)

FORMAT OF THE PRELIMINARY SAFETY ANALYSIS REPORT FOR

INTEGRATED FACILITY FOR RADIATION TECHNOLOGY (IFRT)

[ PSAR should be submitted to AERB in this format, duly signed by

Head of the organisation (employer)]

A. INTRODUCTORY INFORMATION
1(a) Name of the utility/institution setting up
the IFRT :
Mode of communication :
Telephone No. :
Fax. No. :
E-mail :
(b) Postal address of the utility/institution :
2. Name, designation and address of the
applicant officially representing the
utility/institution :
3. Name and address of the designer(s)
of IFRT (with e-mail and fax) :
4. Name and address of the manufacturer
of IFRT (with e-mail and fax) :
5. Project Details :
(a) Type of nuclear/radiation facility :
(b) Objective/purpose :
(c) Nature of the facility :
6. Design class of hot cell structure :
7. Type of radioactive sources to be handled :
8. The Maximum activity to be handled
in the facility : ———— PBq (——— kCi)
9. State whether similar plant is :
operating elsewhere by applicant

202
 B. TECHNICAL DESCRIPTION OF THE INTEGRATED FACILITY FOR
RADIATION TECHNOLOGY (IFRT)
1. Brief Description of the Facility
2. Design details : Design philosophy, defence-in-depth concept, redundancy.
independence and diversity in the design, built-in-safety features provided in
the design.
3. Site of Installation of IFRT : Geotechnical and geological information,
Field investigations, water table, weather, soil
profile, laboratory investigations, allowable
bearing pressure/safe bearing capacity,
chemical analyses of water and soil, site lay
out, documentary evidence of the ownership
of the site, Regulatory Consent issued by
AERB for site approval
- Structural details - type and depth of
foundation and precautions against flooding
- Seismic considerations and IS Tec. doc.
proposed to be followed for construction
- Buildings and residential complexes,
occupancy, etc. within 30m radius of the
facility location; give layout and height of the
adjacent tallest building in the vicinity of
100 m.
- Access roads to the facility : road strength and
width to carry transport flasks containing
radioation sources (culvert/bridge, if any, on
the way - specify)
- Any additional information
4. Biological Shield
- Sketch giving details of shielding wall
surrounding the hot cell and its thickness,
openings, voids, reinforcements, embedment
etc. in the biological shield.
- Sketch of low bay area design details
- Shield material, density, quality assurance
during construction
- Maximum and minimum shield thickness, roof
thickness

203
 - Dose rate profiles anticipated at various
locations: (maximum and minimum values).
Indicate them on a sketch of the facility - control
room, roof, access doors, openings and where
personnel are expected to be stationed for work
or otherwise.
- Maximum dose rate anticipated at various
locations : (Indicate also in a sketch)
- Shielding thickness of lead glass window and
its light transmission efficiency
5. Different Systems of the High Bay Area and Safety Systems/Interlocks
5.1 Hot cell - Design details of Hot Cell with drawing
providing all dimensions
- Details of SS lining inside wall of Hot cell and
roof.
Source cask handling crane
- Technical specification of components of EOT
cranes to be installed for source cask handling
- Details of mechanical arrangement (include
drawing) of source handling cranes.
- No. and locations of the cranes
- Load carrying capacity of the crane, prevention
of source cask from crane, Dimensions of wire
used in crane.
- Safety provisions for operational controls and
interlocking mechanism.
Master slave manipulator (MSM)
- Technical details of master-slave manipulator
(MSM)
- Operating procedures of MSM
- Lifting capacity of MSM
- Installation and testing procedures
5.2 Water pool - Detailed sketch or drawing of water pool for
source storage showing dimensions, water
proofing, lining details, penetrations, piping,

204
 fittings, embedment, locations of level
measuring devices, inlet-outlet water piping
- Water level monitoring system for maximum-
minimum water levels, normal level and
abnormal levels; Total volume of water.
- Buffer storage tank details, overhead water
storage tank details, provision of emergency
water discharge into pool, provision of
overflow/ drainage of water from the pool to
any municipal sewerage lines.
- Municipal water supply quality - TSD, TSS,
hardness and conductivity
- Rate of water supply in emergency
- Quantity of water maintained in pool,
conductivity maximum/minimum, method of
assuring water quality, PH of water.
- Leakage from pool - prevention and assessment
- Normal evaporation water losses from pool
with and without ventilation related to humidity
and temperature
- System to prevent water flooding in the cell
- Method of cleaning water pool
- Pool grill cover strength - prevention of
accidental fall into the pool - during routine
operations like source container handling
operations
- Pool bottom surface plan - loading conditions,
provisions for transport container, intermediate
source storage, if any.
- Corrosion- intermetallic/galvanic, specification
of metals coming in contact with pool water
prevention thereof.
- Maximum water height above sources when it
is taken out from storage containers under water
and expected radiation profiles on the pool
surface, both at normal and abnormal water
levels
- Underwater lights, location, voltage use,
prevention of shocks and electrocution.

205
 - Prevention of accidental fall of person and
material into the pool
- Prevention of syphoning action in pool
- Prevention of accidental entry into the room,
when the water level in the pool is low and when
the sources are in storage position.
- DM water plant capacity and type (anion,
cation, mixed bed etc.)
5.3 Ventilation - Volume of hot cell, including and excluding
high bay and low bay area
- Ventilation rate provided, anticipated minimum
air changes in the hot cell, high bay area, water
pool, low bay area
- Location and routing of ventilated ducts, fans,
duct size, etc. (give sketch), air handling units,
HEPA filters.
- Methods of monitoring ventilation and action
on ventilation failure
- Location of ventilation exhaust and the height
of stack above the hot cell roof. Prevention of
water flooding through ventilation ducts from
roof (sketch)
- Ozone concentration (maximum) anticipated in
the cell with ventilation ON and OFF. Time
duration in minutes for safe concentration of
ozone in the cell (0.1ppm) after the exhaust is
switched off.
- Prevention of entry to the hot cell when unsafe
limit of ozone concentration exists
- Details of safety interlock interlocks to retract
in case of ventilation failure
- Provisions for standby ventilation exhaust fans,
if any
5.4 Access door - Design details of access door with material
used, thickness, its shielding adequacy
- Information on safety interlocks provided to
prevent human access to the hot cell when the
radiation sources are handled.

206
 - Interference to interlocks and source safety and
protection against exposure to radiation or
accidental entry.
- Cautions, visual display and audio alarm
against entry into the cell
5.5 Low bay area - Purpose of the area
- Design details of the area
- Access control to the this area
6. Radioactive Waste and DecontAmination:
- Different types of waste generated; provision
and procedure made for the safe disposal of
the same
- Details of decontamination procedures for hot
cell, tools used in hot cell, flasks and floors,
washbasins
- Collection and storage of solid waste, sump
with stainless steel (SS) lining for collection
of liquid waste
- Discharge methods of gaseous waste from hot
cell, high bay area, filters used and monitoring
methods of gaseous discharge to atmosphere.
7. Radiation Monitoring Instruments:
- Personnel monitoring, contamination moni-
toring and area monitoring equipment,
personnel protective equipment
- Locations of area monitors, zone monitors and
the preset values
- Interlocking mechanism of radiation area
monitors with access into the Hot cell.
- Different types of radiation survey meters
8. Detailed Access Control Procedure and Operating Procedures in the Hot
Cell :
9. Fire Detection System :
- Detection methods of excessive temperature
rise, smoke, fire, and interlock if any in cell
area, high bay and low bay area.

207
 - Type of detectors used and their sensitivity,
location of detectors.
- Validity certification for detectors
- Direction escape route for fire - fire fighting
system, fire hydrants, extinguishers, dry risers,
etc.
10. Control System :
- Give control system description in brief
- Voltage and currents employed, emergency
power standby power, battery backup if any,
- Control logic and flow of command
- Interlock systems for fail-safe operation
11. Audio-visual Alarms/Anunciators :
- Describe the list of audio visual alarms
provided, their location, purpose and
effectiveness - against exposure to radiation,
fire, smoke, toxic gases, radioactive gaseous
waste discharge etc.
12. Electrical System and Emergency Power Supply :
- Provisions made when power failure occurs,
ratings of normal and emergency power
systems, status of systems like manipulators and
cranes
- Emergency power supply caters to cell
ventilation, access door, cell instruments,
remote hoist, cell lights and emergency alarms
13. Design Basis Accident Analysis and Safety Provisions:
Abnormal events mentioned below shall be analysed and methods for
achieving safety under these events shall be described.
(a) Release of radioactivity or accidental exposures in hot cell and water
pool area
(b) Jamming of master-sleeve manipulators
(c) Failure of crane
(i) Failure of cranes brakes during handling of the flask cover
inside cell
(ii) Breaking of wire rope of overhead crane

208
 (d) Slug(s) is missing or rolled from the hot cell table
(e) Heavy contamination of hot cell, contamination of pool water pool
(f) High activity of gaseous waste discharge in air
(g) Failure of access door interlocks
(h) Fire in the IFRT
(i) Failure of ventilation system
(j) Failure of power supply
(k) Failure of PLC
(l) Earthquake at the IFRT site
(m) Flooding of hot cell with water
(n) Leakage of water from pool
(o) Breakage of pool lining
(p) Fall of person in the water pool
The designer/manufacturer shall carry out such analysis to demonstrate means
provided to prevent and handle above situations safely.
14. Decommissioning of IFRT:
- Procedure to be followed when decision is
made to close down the facility permanently.
- Provisions including adequate financial
arrangement for safe disposal of spent/disused
sources.

209
 APPENDIX-6D
(Refer section 3.4.3.4)

FORMAT OF THE FINAL SAFETY ANALYSIS REPORT FOR

INTEGRATED FACILITY FOR RADIATION TECHNOLOGY (IFRT)

[FSAR should be submitted to AERB in this format, duly signed by Head of

the organisation (employer) along with the application for obtaining
the licence for commissioning/operation of IFRT]

A. INTRODUCTORY INFORMATION
1(a) Name of the utility/institution setting
up the IFRT :
Mode of communication :
Telephone No. :
Fax. No. :
E-mail :
(b) Postal address of the utility/ institution :
2. Name, designation and address of the
applicant officially representing the
utility/institution :
3. Name and address of the designer(s)
of IFRT (with e-mail and fax) :
4. Name and address of the manufacturer
of IFRT (with e-mail and fax) :
5. Project Details :
(a) Type of nuclear radiation facility :
(b) Objective/purpose :
(c) Nature of the facility :
6. Design class of hot cell structure :
7. Type of radioactive sources to be handled :
8. The maximum activity to be handled
in the facility : ——— PBq (——— kCi)
9. State whether similar plant is :
operating elsewhere by applicant

210
 B. TECHNICAL DESCRIPTION OF THE INTEGRATED FACILITY FOR
RADIATION TECHNOLOGY (IFRT)
1. Brief description of the facility
2. Design details : Design philosophy, defence-in-depth concept, redundancy.
independence and diversity in the design, built-in-safety features provided in
the design.
3. Site of installation of IFRT: Geotechnical and geological information, Field
investigations, water table, weather, soil profile,
laboratory investigations, allowable bearing
pressure/safe bearing capacity, chemical
analyses of water and soil, site lay out,
documentary evidence of the ownership of the
site, Regulatory Consent issued by AERB for
site approval
- Structural details - type and depth of foundation
and precautions against flooding
- Seismic considerations and IS Tec. doc. 1893
(curent revision) proposed to be followed for
construction
- Buildings and residential complexes,
occupancy, etc. within 30m radius of the facility
location; give layout and height of the adjacent
tallest building in the vicinity of 100m.
- Access roads to the facility : road strength and
width to carry transport flasks containing
radioation sources (culvert/ bridge, if any, on
the way - specify)
- Any additional information
4. Biological shield of hot cell
- Sketch giving details of shielding wall
surrounding the hot cell and its thickness,
openings, voids, reinforcements, embedment
etc. in the biological shield.
- Sketch of low bay area design details
- Shield material, density, quality assurance
during construction
- Maximum and minimum shield thickness, roof
thickness

211
 - Dose rate profiles anticipated at various
locations: (maximum and minimum values).
Indicate them on a sketch of the facility - control
room, roof, access doors, openings and where
personnel are expected to be stationed for work
or otherwise.
- Maximum dose rate anticipated at various
locations : (Indicate also in a sketch)
- Shielding thickness of lead glass window and
its light transmission efficiency
5. Different systems of the high bay area and safety systems/interlocks
5.1 Hot cell - Design details of hot cell with drawing
providing all dimensions
- Details of SS lining inside wall of Hot cell and
roof.
Source cask handling crane
- Technical specification of components of EOT
cranes to be installed for source cask handling
- Details of mechanical arrangement (include
drawing) of source handling cranes.
- No. and locations of the cranes
- Load carrying capacity of the crane, prevention
of accidental fall of source cask from crane,
Dimensions of wire used in crane.
- Safety provisions for operational controls and
interlocking mechanism.
Master slave manipulator (MSM)
- Technical details of master-slave manipulator
(MSM)
- Operating procedures of MSM
- Lifting capacity of MSM
- Installation and testing procedures
5.2 Water pool - Detailed sketch or drawing of water pool for
source storage showing dimensions, water
proofing, lining details, penetrations, piping,

212
 fittings, embedment, locations of level
measuring devices, inlet-outlet water piping
- Water level monitoring system for maximum-
minimum water levels, normal level and
abnormal levels; total volume of water.
- Buffer storage tank details, overhead water
storage tank details, provision of emergency
water discharge into pool, provision of
overflow/drainage of water from the pool to
any municipal sewerage lines.
- Municipal water supply quality - TSD, TSS,
hardness and conductivity
- Rate of water supply in emergency
- Quantity of water maintained in pool,
conductivity maximum/minimum, method of
assuring water quality, PH of water.
- Leakage from pool - prevention and assessment
- Normal evaporation water losses from pool
with and without ventilation related to humidity
and temperature
- System to prevent water flooding in the cell
- Method of cleaning water pool
- Pool grill cover strength - prevention of
accidental fall into the pool - during routine
operations like source container handling
operations
- Pool bottom surface plan - loading conditions,
provisions for transport container, intermediate
source storage, if any.
- Corrosion-intermetallic/galvanic, specification
of metals coming in contact with pool water
prevention thereof.
- Maximum water height above sources when it
is taken out from storage containers under water
and expected radiation profiles on the pool
surface, both at normal and abnormal water
levels
- Underwater lights, location, voltage use,
prevention of shocks and electrocution.

213
 - Prevention of accidental fall of person and
material into the pool
- Prevention of syphoning action in pool
- Prevention of accidental entry into the room,
when the water level in the pool is low and when
the sources are in storage position.
- DM water plant capacity and type (anion,
cation, mixed bed etc.)
5.3 Ventilation - Volume of hot cell, including and excluding
high bay and low bay area
- Ventilation rate provided, anticipated minimum
air changes in the hot cell, high bay area, water
pool, low bay area
- Location and routing of ventilated ducts, fans,
duct size, etc. (give sketch), air handling units,
HEPA filters.
- Methods of monitoring ventilation and action
on ventilation failure
- Location of ventilation exhaust and the height
of stack above the hot cell roof. Prevention of
water flooding through ventilation ducts from
roof (sketch)
- Ozone concentration (maximum) anticipated in
the cell with ventilation ON and OFF. Time
duration in minutes for safe concentration of
ozone in the cell (0.1ppm) after the exhaust is
switched off.
- Prevention of entry to the hot cell when unsafe
limit of ozone concentration exists
- Details of safety interlock interlocks to retract
in case of ventilation failure
- Provisions for standby ventilation exhaust fans,
if any
5.4 Access Door - Design details of access door with material
used, thickness, its shielding adequacy
- Information on safety interlocks provided to
prevent human access to the hot cell when the
radiation sources are handled.

214
 - Interference to interlocks and source safety and
protection against exposure to radiation or
accidental entry.
- Cautions, visual display and audio alarm
against entry into the cell
5.5 Low Bay Area - Purpose of the area
- Design details of the area
- Access control to the this area
6. Radioactive Waste and Decontamination:
- Different types of waste generated; provision
and procedure made for the safe disposal of
the same
- Details of decontamination procedures for hot
cell, tools used in hot cell, flasks and floors,
washbasins
- Collection and storage of solid waste, sump
with stainless steel (SS) lining for collection
of liquid waste
- Discharge methods of gaseous waste from hot
cell, high bay area, filters used and monitoring
methods of gaseous discharge to atmosphere.
7. Radiation Monitoring Instruments:
- Personnel monitoring, contamination moni-
toring and area monitoring equipment,
personnel protective equipment
- Locations of area monitors, zone monitors and
the preset values
- Interlocking mechanism of radiation area
monitors with access into the Hot cell.
- Different types of radiation survey meters
8. Detailed Access Control Procedure and
Operating Procedures in the Hot Cell :
9. Fire Detection System :
- Detection methods of excessive temperature
rise, smoke, fire, and interlock if any in cell
area, high bay and low bay area.

215
 - Type of detectors used and their sensitivity,
location of detectors.
- Validity certification for detectors
- Direction escape route for fire - fire fighting
system, fire hydrants, extinguishers, dry risers,
etc.
10. Control System :
- Give control system description in brief
- Voltage and currents employed, emergency
power standby power, battery backup if any,
- Control logic and flow of command
- Interlock systems for fail-safe operation
11. Audio-visual Alarms/ Anunciators :
- Describe the list of audio visual alarms
provided, their location, purpose and
effectiveness - against exposure to radiation,
fire, smoke, toxic gases, radioactive gaseous
waste discharge etc.
12. Electrical System and Emergency Power Supply :
- Provisions made when power failure occurs,
ratings of normal and emergency power
systems, status of systems like manipulators and
cranes
- Emergency power supply caters to cell
ventilation, access door, cell instruments,
remote hoist, cell lights and emergency alarms
13. Design Basis Accident Analysis and Safety Provisions:
Abnormal events mentioned below shall be analysed and methods for
achieving safety under these events shall be described.
(a) Release of radioactivity or accidental exposures in hot cell and water
pool area
(b) Jamming of Master-sleeve manipulators
(c) Failure of crane
(i) Failure of cranes brakes during handling of the flask cover
inside cell
(ii) Breaking of wire rope of overhead crane

216
 (d) Slug(s) is missing or rolled from the hot cell table
(e) Heavy contamination of hot cell, contamination of pool water pool
(f) High activity of gaseous waste discharge in air
(g) Failure of access door interlocks
(h) Fire in the IFRT
(i) Failure of ventilation system
(j) Failure of power supply
(k) Failure of PLC
(l) Earthquake at the IFRT site
(m) Flooding of hot cell with water
(n) Leakage of water from pool
(o) Breakage of pool lining
(p) Fall of person in the water pool
The designer/manufacturer shall carry out such analysis to demonstrate means
provided to prevent and handle above situations safely.
14. Acceptance test reports after installation of safety systems:
(a) Dose rate profile measurement in the entire facility, strength of
radiation source.
(b) Performance of radiation monitoring and control interlocks
(c) Performance of personnel monitors
(d) Dose concentration measurement with and without ventilation fan
functioning
(e) Assurance and effectiveness of control functions and interlocks
Sketch of the facility and location of dose rate monitoring points and
maximum/minimum dose rate levels should include :
(a) Name of persons carrying out the measurement
(b) Instrument used in the radiation survey
(c) Confidence limits of radiation level measurements
(d) Background radiation levels in each location of measurement
15. Decommissioning of IFRT:
Procedure to be followed when decision is made to close down the facility
permanently.

217
 Provisions including adequate financial arrangement for safe disposal of spent/
disused sources.
16. List of critical safety components:
The manufacturer of IFRT shall provide to the operating organisation a
complete list of components as per following classification:
Group A : Replaceable by manufacturer or with his explicit Consent
Group B : Replaceable to exact specifications
Group C : Replaceable without restriction

218
 APPENDIX-6E
(Refer section 3.4.3.4)

RADIATION PROTECTION MANUAL OF INTEGRATED

FACILITY FOR RADIATION TECHNOLOGY (IFRT)

(OPERATION, MAINTENANCE AND EMERGENCY ASPECTS)

A. ADMINISTRATION AND SAFETY ASSURANCE

(a) Administrative hierarchy/organisational set up
(b) Authorised personnel - Training and qualification of facility
personnel, their knowledge in radiation
safety, responsibilities of each of personnel,
their availability in adequate number,
policies in case of long leave/absence of
certified personnel
(c) Local safety committee : constitution, functions and responsibilities
(d) Procedures for reporting to the regulatory agency on unusual
occurrences and periodic radiation safety status
(e) Procedures in case of change or repairs of H.V. system, safety system/
interlocks, certification of log book entry by RSO
(f) Records of maintenance - maintenance schedule, radiation
monitoring, and calibration of survey meters, etc.
(g) Control and distribution of hot cell/facility keys
(h) Industrial safety aspects - fire equipment, safety accessories etc.
(i) Facility security arrangements, fencing and personnel movement
control etc.
(j) Removal and storage of contaminated material, if any.
(k) Medical assistance - First aid facility, location, periodic medical
examination (once a year), medical facilities and treatment facilities
for radiation incidents
B. MONITORING
(a) Radiation monitoring - Type of area monitors, sensitivity
range, location, interlock alarm set
levels (DM plant/unloading bay,
control room)

219
 (b) Contamination monitoring - On line monitoring and sample
measurement, method of collecting
samples of pool water, accessible
surfaces of source raise system
(c) Personnel monitoring - Number of PM badges, procedure
for their issuance, safe place for
storage, etc.
C. OPERATION PROCEDURES
(a) Master-slave manipulators
(b) External transfer drawer
(c) Cask handling cranes
D. MAINTENANCE PROCEDURE FOR SAFETY SYSTEMS/
INTERLOCKS
(a) Periodic Maintenance - Daily/weekly/monthly/quarterly/yearly
(Items, procedures and schedules)
(b) Procedure for maintenance of D.M. water supplies
(c) Maintenance checking of alarm/ warning devices
E. EMERGENCY PLANNING AND PROCEDURES
(a) Organisational structure and communication links
(b) Name, address and telephone numbers of agencies to be contacted
in case of emergency
(c) Emergency contact telephone/ telex nos. and address of
(i) Head of Institution
(ii) Facility-in-charge
(iii) Radiological safety officer (RSO)
(iv) Regulatory agency (AERB)
(v) Fire safety officer (Local)
(vi) Local fire station
(vii) Local police station
(viii) Local medical hospital, radiation therapy hospitals (nearest)
(d) Type of emergencies envisaged - Prevention/handling of emergencies,
investigation methods, etc. during major leaks of water, explosion
or fire or smoke, radiation emergency, crisis management in case of
emergency, earthquake, floods, other natural calamities.

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 APPENDIX-6F
(Refer section. 3.4.3.4 )

QUALITY ASSURANCE MANUAL (QAM) FOR

INTEGRATD FACILITY FOR RADIATION TECHNOLOGY (IFRT)

A. QUALITY ASSURANCE PROGRAM (QAP)

An adequate quality assurance (QA) program, including appropriate quality
control measures, shall be established for the design and manufacture,
construction, operation and industrial safety of integrated facility for radiation
technology (IFRT). Compliance with the ISO 9000 or IS 14000 series is
desirable. Records of all QA procedures shall be maintained for the entire
life of the IFRT.
B. QUALITY ASSURANCE IN DESIGN OF IFRT:
1.1 Quality Assurance Programme
The responsible organisation shall develop and implement a QA programme,
which describes the overall arrangements for the management, performance
and assessment of the IFRT. This programme should also provide the means
to ensure that all work is suitably planned, correctly performed and properly
assessed. Procedures should be defined by the responsible organisation for
control of design activities to ensure that the design of the IFRT fulfils
specified requirements.
1.2 Grading
A graded approach based on the relative importance to radiological safety of
each item, service or process shall be used.
1.2.1 The design activities, which could be graded, include:
(a) The level and detail of analysis of design
(b) The need for and level of design review and approval
(c) The degree of verification of design
(d) The controls applied to design change
(e) The detail of design records and their retention times
(f) The need for alternative calculations to be carried out
(g) The need to qualify or test the design output
(h) The need for qualification tests for design

221
1.3 Organisation
The responsible organisation shall identify the principal designer who has
responsibility for specifying the design requirements and for approving the
design output on its behalf.
1.4 Interfaces
Interface arrangements shall be agreed between organisations involved in
design activities. Interface that should be addressed are for example:
(a) Interfaces between technical disciplines within the design organi-
sation
(b) Principal designer with:
(i) Siting organisation
(ii) Construction organisation
(iii) Commissioning organisation
(iv) Operating organsiation
(v) Decommissioning organsiation
(vi) Regulatory body
1.5 Planning
Plans used in design should include the following where appropriate:
(a) Scope of work, including work carried out by other organisations
(b) Design methods
(c) Software requirements (software to be developed or software codes
to be validated for use)
(d) Test requirements, including qualification tests, prototype, seismic,
etc.
(e) Design review, verification and validation requirements
(f) Resource requirements
(g) Special training requirements
(h) Schedule of activities
(i) Points at which checks of the design process will take place and the
frequency of such checks
(j) Inputs from safety, reliability, maintainability, human factors,
standardisation and other disciplines.

222
1.6 Non-conformance Control and Corrective Actions
A system for the control of non-conformances and their corrective actions
should be established.
1.7 Document Control and Records
Procedures for the preparation, review, approval, issue, modification and
control of documents shall be established.
C. QUALITY ASSURANCE DURING CONSTRUCTION OF CIVIL
ENGINEERING STRUCTURES OF IFRT
1.1 Quality Assurance Programme
The responsible organisation shall develop and implement a QA programme,
which describes the overall arrangements for the management, performance
and assessment of civil engineering structures for IFRT during construction.
This programme should provide the means to ensure that all work is suitably
planned, correctly performed and properly assessed in order to implement
design intent in the construction.
1.2 Grading
Work procedures should be defined for control of construction activities at
site and it should be reviewed and approved before use. A graded approach
based on the relative importance to safety of each item, service or process
shall be used. The construction activities, which could be graded, include:
(a) Qualification of special construction processes and the personnel to
carry them out
(b) Detail and need for inspection plans
(c) Level of traceability
(d) Level of in process controls and need for hold points
(e) Records and archived samples
1.3 Organisation
The responsible organisation should formally appoint a person on its staff to
be responsible for construction activities. The appointed person should have
the necessary resources within the construction organisation to discharge the
following responsibilities:
(i) Ensuring that construction and installation work is carried out in
accordance with design specifications, drawings, procedures and
instructions, including the implementation of specified QA
requirements.

223
 (ii) Ensuring that construction and installation work undertaken,
including work by suppliers, is co-ordinated, conducted and
completed in accordance with planned programmes of work.
(iii) Controlling access to the construction site.
1.4 Interfaces
Interface arrangements should be agreed between the construction
organisation, suppliers and other organisational units performing the work.
They should be defined in writing and should be included in procurement
documents. Interfaces that should be addressed are:
(a) Construction organisation with supplier
(b) Construction organisation with operating organisation
(c) Suppliers with sub-suppliers
(d) Construction organisation with the principal designer
(e) Construction organisation with siting organisation
(f) Interfaces between construction organisation and the regulatory body
1.5 Planning
All construction activities should be planned. The plan should define:
(a) The activities to be performed in manageable units
(b) The planned sequential order and duration of these activities
(c) The resource allocation for each activity
1.6 Non-conformance Control and Corrective Actions
The non-conformances that are required to be reported to the construction
organisation should be identified. Suitable corrective action should also be
recorded.
1.7 Document Control and Records
Procedures for the preparation, review, approval, issue, modification and
control of documents should be established. The record system should be
established which includes the arrangements and responsibilities for the
categorisation, receipt, indexing, storage, retrieval and disposal of construction
records. Records should include all those, which record the as-built condition
of structures, systems and components.
1.8 The civil engineering construction should be carried out following the relevant
Indian standard codes/specifications. Quality of civil construction should
satisfy the requirements of appropriate Indian standard codes/specifications

224
 and that of product specifications. Typical list of topics to be covered in QA
programme for the civil engineering construction is given as below:
(a) Formwork, shuttering and pre-construction activities
(b) Concreting and curing
(c) Post concrete inspection
(d) Repair
(e) Fabrication and erection of embedded parts (EP)
(f) Fabrication and erection of structural steel
(g) Brick work
(h) Grounding network
(i) Painting for steel structure
(j) Finishing and repair control
(k) Painting of main plant structures/concretes faces
(l) List of procedures
(m) Miscellaneous items such as organisation chart of QA civil, flow
chart showing production of good uniform concrete, schematic
diagram on procedure of concrete mix design etc.
(n) Density of the concrete in construction of walls and roof of irradiation
cell shall be maintained at least 2.5 g/cc and it shall be ensured that
no voids or air gaps are present during concrete filling.
D. INDUSTRIAL SAFETY DURING CONSTRUCTION OF CIVIL
ENGINEERING STRUCTURES FOR IFRT
A policy reflecting industrial safety regulations should be established for all
personnel, including suppliers and visitors. These should be in line with the
prevailing factory rules. The policy should include arrangements for the
effective planning, organisation, monitoring and review of the preventive
and protective measures.
1.1 Management should provide all necessary support to the Contractor to ensure
health and safety of the construction personnel.
1.2 Job hazard analysis should be prepared before the start of construction.
1.3 Industrial safety at the construction site should be enforced by a safety officer.
1.4 All construction equipment should be tested prior to its use.
1.5 Construction personnel should be given orientation program on industrial
safety.

225
1.6 Accident statistics should be maintained at the construction site.
1.7 Appropriate arrangements for fire safety and first aid should be available.
E. QUALITY CONTROL-RESPONIBILITY OF MANUFACTURER/
DESIGNER
1.1 Equipment and instrument quality and certification
1.2 Manufacturing material quality, tolerance of parts, fabrication specifications,
inspection during manufacturing and tests and adopted quality assurance
procedures.
1.3 Quality of components used
1.4 Certification of wiring, electrical, mechanical safety
1.5 Documentation of quality assurance and control procedures
1.6 Wire rope, source rack, hydraulic piping and pumps, specification, quality
assurance
1.7 Sensors and their quality assurance

226
 (THIS IS THE ONLY APPENDIX FOR RADIOTHERAPY FACILITY)

APPENDIX-7E
(Refer section 3. 5.1.5)
(Refer section 3.8.4)

RADIATION PROTECTION MANUAL OF

RADIOTHERAPY FACILITY

(Applicable for Telegamma Accelerator and Brachytherapy Facilities)

(Operation, Maintenance and Emergency Aspects)

A. ADMINISTRATION AND SAFETY ASSURANCE

(a) Administrative hierarchy/organisational set up
(b) Authorised personnel - Training and qualification of facility
personnel, their knowledge in radiation
safety, responsibilities of each of perso-
nnel, their availability in adequate
number, policies in case of long leave/
absence of certified personnel
(c) Local safety committee : constitution, functions and responsibilities
(d) Procedures for reporting to the regulatory agency on unusual
occurrences and periodic radiation safety status
(e) Procedures in case of change or repairs of H.V. system (if applicable),
safety system /interlocks, certification of log book entry by RSO
(f) Records of maintenance - maintenance schedule, radiation
monitoring, and calibration of survey meters, etc.
(g) Control and distribution of radiotherapy rooms.
(h) Industrial safety aspects - fire equipment, safety accessories etc.
(i) Facility security arrangements, fencing and personnel movement
control etc.
(j) Removal and storage of contaminated material, if any.
(k) Medical assistance - First aid facility, location, periodic medical
examination (once a year), medical facilities and treatment facilities
for radiation incidents
B. MONITORING
1. Radiation monitoring - Type of area monitors, sensitivity,
range, location, alarm set levels for

227
 radiation zone monitors and
radiation survey meters.
2. Contamination monitoring - Method of collecting samples and
measurement of activity for
contamination checks.
3. Personnel monitoring - Number of personnel monitoring
badges, procedure for their issuance,
safe place for storage, etc.
C. OPERATIONAL PROCEDURES
The procedures to be followed prior to treatment delivery such as daily quality
assurance (QA) checks.
D. MAINTENANCE PROCEDURE FOR SAFETY SYSTEMS/
INTERLOCKS
Periodic maintenance - Daily/weekly/monthly/quarterly/yearly : items,
procedures and schedules
Maintenance and checking of alarm/ warning devices
E. SOURCE LOADING/UNLOADING PROCEDURES FOR
TELEGAMMA AND BRACHYTHERAPY
Procedure to be adopted for source replacement in the event of source decay
or disused:
Procedure for source loading/unloading- responsible agency/agencies
Procedure of movement of source container for source load/unload and
responsible personnel
Test report for source container handling and lifting system
F. EMERGENCY PLANNING AND PROCEDURES
(a) Organisational structure and communication links
(b) Name, address and telephone numbers of agencies to be contacted
in case of emergency
(c) Emergency contact telephone/telex nos. and address of
(i) Head of institution
(ii) Facility-in-charge
(iii) Radiological safety officer (RSO)

228
 (iv) Regulatory agency (AERB)
(v) Fire safety officer (Local)
(vi) Local fire station
(vii) Local police station
(viii) Local medical hospital, radiation therapy hospitals (nearest)
G. TYPE OF EMERGENCIES ENVISAGED
Prevention/handling of emergencies, investigation methods, etc. during
treatment, explosion or fire or smoke, radiation emergency, crisis management
in case of emergency, earthquake, floods, other natural calamities.

229
(APPENDIX 8C-I, 8C-II, 8C-III AND 8E ARE FOR DIAGNOSTIC FACILITIES)

APPENDIX-8C-I
(Refer section 3.6.3)

ACCEPTANCE/PERFORMANCE/QUALITY ASSURANCE TEST FOR

COMPUTED TOMOGRAPHY (CT) SCANNER

PART I

INTRODUCTORY INFORMATION

1.1. Name and address of the :

manufacturer
1.2 Name and address of local :
agent/supplier
1.3. Name and address of the :
institution, where the scanner
is tested
1.4 Model name of the scanner :
1.5 Features of the scanner : Conventional/Spiral
Single slice/Multiple slice
1.6 Tests conducted by :

Date: Signature
Name
Designation
Company

230
 APPENDIX-8C-I
(Refer section 3.6.3)

PART II

SPECIFICATIONS AND TECHNICAL DETAILS OF THE SCANNER

A. X-RAY GENERATOR

1. Make and model :

2. Operating potential (kVp) :
3. Operating current (mA) :
4. Mains requirement :
5. Generator capacity (power) :
6. Scan time per rotation :
7. Scan time for full helical scan :
8. Type of rectification : Full wave/ multi-pulse

B. X-RAY TUBE

1. Make and model of the tube :

2. Type of anode/material/angle : Rotating/stationary
3. No. of focal spots : One/two
Focal spot dimensions :
Focus-1 ———— mm X ———— mm
Focus-2 ———— mm X ———— mm

C. BEAM COLLIMATION SYSTEM

1. Selectable slice thickness in mm/ :

slice acquisition mode

231
2. Pre-patient/post-patient collimator :
(collimator width)/(detector width)
3. Fan angle of scan beam :
D. GANTRY

1. Type of the scan motion : Rotate-Rotate/ Stationary-Rotate

2. Continuous rotation : available (Limits : )
: not available
3. Rotation mechanism : slip ring/other
4. Gantry aperture diameter : ———————— cm
5. Gantry tilt (maximum)
Gantry top towards couch : ——————
Gantry top away from the couch : ——————
Angular accuracy : ±
6. Light-field localiser type : Laser/focussed light beam
Position of light field localizer : At scan plane/external to scan
aperture
7. Focus-isocentre distance :
8. Focus-detector distance :
9. Maximum field of view (FOV) :
10. Bi-way patient communication system :

E. PATIENT SCANNING TABLE

1. Maximum movements
(Full out to full in scan table length): ————— cm
Minimum table incrementation
available : ————— mm
Indexing accuracy : ± ———— mm
Minimum table height : ± ———— cm
Maximum table height : ± ———— cm

232
2. Location of table position indicators
Gantry : Yes/No
Table : Yes/No
Control console : Yes/No
Scan image : Yes/No
3. Table tilt : Possible/Not possible
If possible
Head end up : ——————
Head end down : ——————
Angulation accuracy : ——————

F. DETECTORS

1. Type : Scintillator/photodiode
Scintillator/PM tube
Pressurised xenon chamber
Other (specify)
Type of scintillator :
2. Number of detectors (total) :
Number of reference detectors :
Number of measuring detectors :
Total No. of detector rows :
Number of measuring channels :
3. Recommended calibration frequency
Air calibration scans :
Water calibration scans :
4. Availability of imaging phantom : Yes/No

233
 APPENDIX-8C-I
(Refer section 3.6.3)

PART-III

A. MECHANICAL TESTS

A.1 Alignment of Table to Gantry

Check the congruence between the gantry midline and table midline using
plumb line.
Result (Gantry midline to table midline) :
Tolerance : ± 5 mm
A.2 Scan Localisation Light Accuracy (use film without screen)
Exposure parameters : kVp : mAs: Slice thickness (min) :
Result :
Alignment error : Internal laser light :—————— mm
External laser light:—————— mm
Tolerance : ± 2.0 mm
A.3 Gantry Tilt
Exposure parameters : kVp : mAs:
Result :
Actual gantry tilt :
Measured gantry tilt :
Tolerance : ± 30
A.4 Table Position /Incrementation ( same film can be used for tests A2, A3, and
A4)
Initial table position (arbitrary) :
Load on couch :
Exposure parameters : kVp : mAs: Slice thickness :
Applied table incrementation :
Tolerance : ± 2.0 mm

Table position from 1 cm 2 cm 3 cm 4 cm 5 cm

reference position
Expected
Measured

234
 B. COLLIMATION TEST

B.1 Radiation Profile Width

Exposure parameters : kVp : mAs:
Result :

Applied slice thickness Measured density profile

(mm) width (FWHM)

Tolerance : ± 1.0 mm (without post patient collimator)

C. TESTS ON X-RAY GENERATOR

C.1 Measurement of Operating Potential

Set kV mA station mA station mA station mA station

I II III IV

Tolerance : ± 2 kVp
C.2 Measurement of mA Linearity
Operating parameters : kVp : Slice thickness : Time:

mA settings mAs Output μGy/mAs

μGy (X)

Xmax – Xmin
Coefficient of linearity (COL) = —————
Xmax+ Xmin

Tolerance in COL : ± 0.1

235
C.3 Measurement of Timer Linearity
Operating parameters : kVp : Slice thickness : mA:
mA settings mAs Output μGy/mAs
μGy (X)

Xmax – Xmin
Coefficient of linearity (COL) = —————
Xmax+ Xmin

Tolerance in COL : ± 0.1

C.4 Output Consistency
Operating parameters : mAs : Slice thickness :

kVp Output Mean (X) COV

1 2 3 4 5

Coefficient of Variation (COV) = [ ∑ (Xi - Xmean )2/(n-1)]½ / Xmean

Tolerance in COV : ± 0.05

D. CONTRAST RESOLUTION

D.1 Low Contrast Resolution

Use low contrast resolution test phantom.
Operating parameters : kVp : mAs : Slice thickness
Window width :
Result :
Low contrast resolution : ————— mm at ———— % contrast difference
Tolerance : 5.0 mm at 1% contrast difference (minimum)
2.5 mm at 0.5 % contrast difference (expected)

236
D.2 High Contrast Resolution
Use high contrast resolution test phantom.
Operating parameters : kVp : mAs : Slice thickness :
Window width : Use high resolution algorithm.
Result :
Size of the smallest resolvable bar/hole pattern : ____________ mm
(___________ lp/cm)
Tolerance : At 10% contrast difference the size of the bar/hole pattern that
could be resolvable should be 1.6 mm (≈ 3.12 lp/cm).
Expected high contrast resolution : 0.8 mm (≈ 6.25 lp/cm)

E. RADIATION DOSE TESTS

E.1 Measurement of Computed Tomography Dose Index (CTDI)

Use pencil ionisation chamber connected to a suitable electrometer or TLD,
in conjunction with a head/body phantom. Measure the dose in the axial and
peripheral cavities of the phantom for typical techniques.
Operating parameters : kVp : 80 / 100 / 140 mAs : 100
Slice thickness :
Result Head Body

Axial dose : ———— mGy/mAs ————— mGy/mAs

Peripheral dose : ———— mGy/mAs ————— mGy/mAs
: ———— mGy/mAs ————— mGy/mAs
: ———— mGy/mAs ————— mGy/mAs
: ———— mGy/mAs ————— mGy/mAs
Peripheral dose : ———— mGy/mAs ————— mGy/mAs
(mean)
CTDIc(central) : ———— mGy/mAs ————— mGy/mAs
CTDIp (mean) : ———— mGy/mAs ————— mGy/mAs
Weighted CTDI (CTDIw) = 1/3 CTDIc + 2/3 CTDIp
CTDIw : ————— mGy/mAs

237
 Tolerance : ± 20% of the quoted value (expected)
± 40% of the quoted value (maximum)

F. RADIATION LEAKAGE LEVELS

FROM X-RAY TUBE HOUSING AT
1 m FROM THE FOCUS

Operating Potential : kV, mAs: mA X seconds

(use maximum kV available in the machine for leakage measurement)

Radiation leakage level (mR/hour)

Front (Cathode) Back (Anode) Left Right

Maximum leakage = —— mA minutes X —— Maximum leakage mR/h

60 X —— mA used for measurement

Maximum radiation leakage from tube = —————— mR in one hour

Result: Maximum radiation leakage at 1 meter from the focus for workload
of 180 mAminutes in one hour is ___________ mR.

Recommended upper limit:

Leakage radiation level at 1 meter from the focus should be ≤ 115 mR in one
hour.

Date: Tested by: Signature

Name
Designation
Company

Signature of customer/user

(Seal of the institution)

238
 APPENDIX-8C-II
(Refer section 3.6.3 and 3.13.2.5)

ACCEPTANCE/PERFORMANCE/QUALITY ASSURANCE TEST FOR

DIAGNOSTIC X-RAY UNIT/CATH LAB

A. DETAILS OF THE DIAGNOSTIC X-RAY UNIT

1. Name of the manufacturer :
2. Name and address of the of the :
institution where the unit tested
3. Name(s) of person(s) testing :
the unit
4. Dates and duration of the tests :
5. Model name :
6. No. of X-ray tubes : One/two
7. Maximum rating of the unit :
(a) Potential (kV) :
(b) Current (mA) :
(c) Exposure time (seconds) :
8. Name of the Manufacturer of :
the X-ray Tube
9. Type of Detector : Screen film/CR/Digital/IIT
10. Total filtration : —————— mm of Al

Date: Tested by:

Signature:
Name:

B. CONGRUENCE OF RADIATION & OPTICAL FIELD

Operating Parameters :
Distance : 100 cm, kV : 60 kV, mAs : 5 ( mA = ————, s = ———— )

239
 (a) Shift in the edges of the radiation field
X= cm % of TFD (TFD: Table to focus distance)
X’ = cm % of TFD
Y= cm % of TFD
Y’ = cm % of TFD
Tolerance : 2 % of TFD
(b) Difference in the dimensions of the radiation and optical fields
X + X’ = cm % of TFD
Y + Y’ = cm % of TFD
Tolerance : 3 % of TFD
(c) Difference between sums of lengths and widths of optical and
radiation fields
X + X’ + Y + Y’ = cm % of TFD
Tolerance : 4 % of TFD
1. CENTRAL BEAM ALIGNMENT
Observe the images of the two steel balls on the radiograph and evaluate tilt
in the central beam.
Tilt in the central beam is _____________

Tolerance : Tilt < 1.50

2. FOCAL SPOT SIZE
Distance : 60 cm, kV : 70, mAs : 40 - 50 (mA = 40-50, s = 1.6)
(non-screen film technique)
Large focal spot size : ———— mm X ———— mm (stated)
: ———— mm X ———— mm (measured)
Small focal spot size : ———— mm X ———— mm (stated)
: ———— mm X ———— mm (observed)
Tolerance :
1. + 0.5 f for f < 0.8 mm
2. + 0.4 f for 0.8 ≤ f ≤ 1.5 mm
3. + 0.3 f for f > 1.5 mm

240
3. TIMER CHECK

Set time Observed time % Error

Tolerance: ± 10 %
4. ACCELERATING VOLTAGE
Operating parameters : Distance : 40 - 50 cm

Applied kVp Measured kVp

60 kV (40 mAs)
70 kV (32 mAs)
80 kV (25 mAs)
90 kV (20 mAs)
100 kV (20 mAs)
kV max (15 mAs)

Tolerance : ± 5 kV
5. LINEARITY OF mA LOADING STATION
Operating parameters : Distance : 100 cm, kV : 60, Time : 1.0 second

mA Out put Average mR/mAs

Range (X)
1 2 3
100
200
300

Xmax – Xmin
Coefficient of linearity = ——————
Xmax + Xmin

Tolerance : COL < 0.1

241
6. LINEARITY OF TIMER
Operating parameters : Distance : 100 cm, kV : 50, mA : 200

Time Out put Average mR/mAs

(X)
1 2 3
0.5
1.0
1.5

Xmax – Xmin
Coefficient of linearity = ——————
Xmax + Xmin

Tolerance : COL < 0.1

7. OUTPUT CONSISTANCY

Operating parameters : Distance : 100 cm

Applied mA Output Average
kV (X)
1 2 3 4 5
70
80
100
120

Coefficient of variation = [ ∑ (Xi - Xmean)2/(n-1)]1/2 / Xmean

COV =
————— for ———— kV
————— for ———— kV
————— for ———— kV
————— for ———— kV
————— for ———— kV
Tolerance : COV < 0.05

242
8. TOTAL FILTRATION
Operating parameters : Focus to detector distance : 100 cm
kV : 100, mAs : 20 (mA : 100, Time : 0.2 seconds)

Added filter Output %

(mm Al ) Transmission
1 2 Average
0
1.0
2.0
3.0
4.0
5.0
6.0
Table top

[Plot a graph between Al thickness added mm (X-axis) and % transmission

(Y-axis); find HVT from graph]
Total filtration = —————— mm of Al. (from table)
Tolerance : 1.5 mm Al for kV ≤ 70
2.0 mm Al for kV ≤ 100
mm Al for kV > 100
Aluminium equivalence of the table top is ————— mm of Al at 100 kV.
Recommended upper limit : Al equivalence of table top ≤ 1.0 mm at 100 kV.
9. PERFORMANCE OF THE IMAGE INTENSIFIER (II)
(a) Details of the II tube:
1. Name and address of the manufacturer:
2. Make, model and format of the II tube:
3. Make and model of the X-ray tube used for testing the II tube:
(b) Low contrast sensitivity:
Diameter of the smallest size hole clearly seen on the monitor:—————

243
 Recommended performance standard:
Hole of 1/8" diameter must be clearly seen.
(c) High contrast sensitivity
Bar strips of frequency ———— lp/mm resolved on the monitor.
Recommended performance standard:
Bar strips of 1.5 lp/mm must be resolved.
(d) Exposure rate at table top
———————— R/minute at ———————— kV(maximum) and
———————— mA (maximum)
Recommended upper limit:
Exposure rate at table top ≤ 5.7 R/minute at focus to table top distance
—— cm.
[focus to table top distance shall not be less than 30 cm.]
10. TUBE HOUSING LEAKAGE
Operating parameters :
Applied voltage : ———— kV , mAs : ———— ( ———— mA, 1.5 Sec.)
(Maximum) (minimum)

Location Exposure level (mR/h)

(at 1.0 m from
the focus) Left Right Front Back Top
Tube
Collimator

Work load =
Maximum leakage = 180 mA minutes X — Maximum leakage mR/hr
60 X — mA used for measurement
Maximum radiation leakage from tube = —————— mR in one hour
Result : Maximum radiation leakage at 1 meter from the focus for workload
of 180 mAminutes in one hour is ______ mR.
Recommended upper limit : Leakage radiation level at 1 meter from the
focus should be ≤ 115 mR in one hour.

244
 TABLE-1 : EFFECTIVE FOCAL SPOT SIZE FOR
A MAGNIFICATION OF 4/3

Smallest group lp/mm Effective focal spot size

resolved (mm)
1 0.84 4.3
2 1.00 3.7
3 1.19 3.1
4 1.14 2.6
5 1.68 2.2
6 2.00 1.8
7 2.38 1.5
8 2.83 1.3
9 3.36 1.1
10 4.00 0.9
11 4.76 0.8
12 5.66 0.7

TABLE 2 : HVT AS A FUNCTION OF FILTRATION AND TUBE

POTENTIAL (SINGLE PHASE GENERATORS)

Total Peak potential (kV)

filtration 30 40 50 60 70 80 90 100 110 120
(mm Al)
Half Value Thickness (mm Al)
0.5 0.36 0.47 0.58 0.67 0.76 0.84 0.92 1.00 1.08 1.16
1.0 0.55 0.78 0.95 1.08 1.21 1.33 1.46 1.58 1.70 1.82
1.5 0.78 1.04 1.25 1.42 1.59 1.75 1.90 2.08 2.25 2.42
2.0 0.92 1.22 1.49 1.70 1.90 2.10 2.28 2.48 2.70 2.90
2.5 1.02 1.38 1.69 1.95 2.16 2.37 2.58 2.82 3.06 3.30
3.0 1.49 1.87 2.16 2.40 2.62 2.86 3.12 3.38 3.65
3.5 1.58 2.00 2.34 2.60 2.86 3.12 3.40 3.68 3.95

245
 TABLE 3 : HVT AS A FUNCTION OF FILTRATION AND TUBE
POTENTIAL (THREE PHASE GENERATORS)

Total Peak potential (kV)

filtration 60 70 80 90 100 110 120 130 140
(mm Al)
Half value thickness (mm Al)

2.5 2.2 2.4 2.7 3.1 3.3 3.6 4.0

3.0 2.3 2.6 3.0 3.3 3.6 4.0 4.3 4.6 5.0
3.5 2.6 2.9 3.2 3.6 3.9 4.3 4.6

246
 APPENDIX-8C-III
(Refer section 3.13.2.5)

ACCEPTANCE/PERFORMANCE/QUALITY ASSURANCE TEST FOR

MAMMOGRAPHY UNIT

1. DETAILS OF THE MAMMOGRAPHY UNIT TESTED

1.1 Name and address of the :
manufacturer
1.2 Name and address of the of the :
institution where the unit tested
1.3 Name(s) of person(s) testing :
the unit
1.4 Dates and duration of the tests :
1.5 Type of model : Film-screen radiography/Digital
1.6 Maximum rating of the unit :
(a) Operating potential (kV) :
(b) Current (mA) :
(c) Exposure time (s) :
1.7 Name of the manufacturer of the :
X-ray tube
1.8 Total filtration
(Material and thickness) : ———————— mm (Al/Mo)
2. MECHANICAL CHARACTERISTICS
2.1 Locking facility adequacy
For immobilizing the X-ray tube : Yes/No
satisfactory
2.2 Accuracy of tube orientation
Indication satisfactory : Yes/No
2.3 Movement of field limiting
diaphragm satisfactory : Yes/No
2.4 Alignment of compression
device satisfactory ? : Yes/No

247
2.5 Locking facility of the compression
device satisfactory ? : Yes/No
3 DISPLAYS/INDICATORS
3.1 CONTROL PANEL
3.1.1 Power ‘ON’ display
Provided ? : Yes/No
Satisfactory ? : Yes/No
3.1.2 Tube current display
Provided ? : Yes/No
Satisfactory ? : Yes/No
3.1.3 Tube potential display
Provided ? : Yes/No
Satisfactory ? : Yes/No
3.1.4 Exposure time selection : Yes/No
Satisfactory
Any other indicator (s) :
(Please specify)
3.2 TUBE HOUSING
3.2.1 Material and thickness of inherent
filtration indicated ? : Yes/No
3.2.2 Material and thickness of added
filtration indicated ? : Yes/No
3.2.3 Total filtration indicated ? : Yes/No
3.2.4 Focal spot location indicated ? : Yes/No
Any other indication (s)
(Please specify) :
4. RADIATION CHARACTERISTICS
4.1 Congruence of Radiation and Optical Fields
Focus to Film Distance : 60 cm.
Result : (a) Shift in the edges of the radiation field
X = ____________ cm % of TFD
X’ = ____________ cm % of TFD

248
 Y= ____________ cm % of TFD
Y’ = ____________ cm % of TFD
Tolerance : 2% of TFD
(b) Difference in the dimensions of the radiation and optical fields
⎪X⎪ + ⎪X’⎪ =__________ cm % of TFD
⎪Y⎪ + ⎪Y’⎪ =__________ cm % of TFD
Tolerance : 3% of TFD
(c) Difference between sums of lengths and widths of optical
and radiation field
⎪X⎪ + ⎪X’⎪ + ⎪Y⎪ + ⎪Y’⎪ =__________cm % of TFD
Tolerance : 4% of TFD
(d) Observe the images of the two steel balls on the radiograph.
Refer Table 1 for evaluating tilt in the central beam

Result : The tilt in the central beam is ______o (degree).

Tolerance : Tilt < 1.5 o

5. FOCAL SPOT SIZE:
Large focus : Stated __________ mm x ____________ mm
: Measured _______ mm x ____________ mm
Small focus : Stated __________ mm x ____________ mm
: Measured _______ mm x ____________ mm
Result :
Tolerence : (i) + 0.5 f for f < 0.8 mm
(ii) + 0.4 f for 0.8 ≤ f ≤ 1.5 mm
(iii) + 0.3 f for f > 1.5 mm
Refer Table 1 for evaluating the focal spot size

249
6. ACCELERATING VOLTAGE
Result : Set kVp Measured kVp

Tolerance : ± 1 kV
7. TIMER CHECKING
Exposure parameters : ________ kV, ________ mA.

Time Exposure parameters Time (seconds) % Error

(seconds) mA kV Set Recorded
t < 0.2
0.2 < t < 1.0
0.5 < t < 1.0
t > 1.0

Tolerence : ± 10 %

8. TOTAL FILTRATION AND ALUMINIUM EQUIVALENCE OF THE

COMPRESSION DEVICE
(i) Molybdenum target, Beryllium window
Added filter thickness =———— mm Molybdenum

Operating mAs Added filter (mm Al) HVT

potential compression device mm Al
28 kVp 0.0 0.1 0.2 0.3 0.4 0.5

Result: The HVT of the unit is = _______________ mm of Al for 28 kVp

Recommended Value : 0.3 mm Al ≤ HVL ≤0.37 mm Al at 28 kVp
(ii) Tungsten target, Glass/Beryllium window
Added filter thickness = ————— mm Molybdenum/Aluminium/
Rhodium

250
 Operating mAs Added filter (mm Al) HVT
potential mm Al
49 kVp 0.0 0.1 0.20 0.50 1.00 1.5 2.0

Result: The HVT of the unit is =______________ mm of Al for 49 kVp

Recommended value :0.8 mm Al ≤ HVL ≤ 1.0mm Mo/Rh filter
1.1 mm Al≤ HVL ≤1.6 mm Al filter
Al equivalence of the compression device ≤ 0.1 mm of Al
≤ 2.0 mm of plexi glass
9. LINEARITY OF mA LOADING STATION
Operating Potential : kV : ______ ; Seconds : ______ ;

mA Range mA X, Instrument reading (mR) Avg. mR/mAs

ξ M
1 2 3 4 5
50 < ι < 100
100 < ι < 200
200 < ι <400
400 < ι < 800

Result : Coefficient of linearity for mA loading stations are _________

and ___________ for small focus and large focus, respectively.
Tolerance : Coefficient of linearity < 0.1
9.1 Linearity of Timer:
kVp : _________ ; mA ____________ ;

Time s X, Instrument reading (mR) Avg. mR/mAs

(seconds) ξ M
1 2 3 4 5
0.2 < ι < 0.4
0.4 < ι < 0.6
0.6 < ι < 0.8
0.8 < ι < 1.5

251
 Result : Coefficient of linearity for timer of the unit is ___________
Tolerance : Coefficient of linearity < 0.1
9.2 Output Consistence:

Operating mAs X, Instrument reading (mR) Avg. mR/mAs

potential ξ M
1 2 3 4 5

Tolerance : Coefficient of variation < 0.05

9.3 Radiation Leakage Levels from X-ray Tube Housing at 1 metre from the
Focus
Operating potential : ________ kV, mAs : _______ mA x ______seconds

Radiation leakage level (mR/h or mR)

Cathode Anode Stand Front Top

Result : Maximum radiation leakage at 1 metre from the focus for work-
load of 180 mA
minutes in one hour is ___________ mR.
Recommended upper limit :
Leakage radiation level at 1 metre from the focus
≤ 115 mR in one hour.
9.4 Radiation Leakage Levels from the Diaphragm/Collimator at 1 metre from
the Focus
Operating potential : ________ kV, mAs : ________ mA x ________seconds

Radiation leakage level (mR/h or mR)

Cathode Anode Stand Front Top

Result : Maximum radiation leakage through diaphragm/collimator at 1 metre

from the focus for work-load of 180 mA minutes in one hour is
____________ mR.

252
 Recommended Upper Limit:
Radiation level due to leakage through diaphragm/ collimator at 1 metre from
the focus ≤ 115 mR in one hour.
9.5 Calibration of Compression Device:
9.6 Testing of Automatic Exposure Control Device:

Date: Tested by:

Signature:
Name:

253
 APPENDIX-8E
(Refer section 3.6.3 )

RADIATION PROTECTION MANUAL

Radiation Protection Manual (RPM) for Diagnostic X-ray facilities

including Computed Tomography(CT)/Interventional Radiology
Istallations and Facilities Engaged in the Commercial Production of
Radiation Generating Equipment.

A. Administrative Hierarchy/Organisational set up:

Authorised personnel: Describe the organisational/management
set up responsible for radiation safety.
State the name, qualifications and training
of Radiologist(s) and technicians and their
work experiences in radiation field.
State the name of the person nominated for
Radiological afety Officer.
Procedures for reporting to the AERB for annual radiation safety status report.
B. Monitoring
Describe the policy for issuing personnel monitoring badges, their safe storage
and record keeping of personnel monitoring history of radiation workers.
Describe the local working rules and internal investigative procedure for
incidents or accidents.
Describe the procedure for monitoring of radiation working areas.
C. Operational Procedures
Describe the methodology for minimising repetition of diagnostic X-ray
examinations.
Describe the provisions for medical research (if applicable to the facility) is
subject to the consideration by an ethical review committee.
D. Maintenance Procedure for Safety Systems/Interlocks
Describe maintenance data of periodic equipment services, testing and
maintenance and their record keeping.
Describe inventory of all the X-ray equipment in the institution
(manufacturer’s name, model name, AERB type approval No. of the installed
units and their location in the premises).

254
 Describe the CT/Interventional Radiology unit’s Quality Assurance (QA)
programme.
E. Emergency Planning and Procedures
Name, address and telephone numbers of individuals/agencies to be contacted
in case of emergency
Emergency contact telephone/telex nos. and address of
(i) Head of the Institution
(ii) Head of the Radiology Department
(iii) Radiological Safety Officer (RSO)
(iv) Service Engineer
(v) Fire Officer(Local)
(vi) Local Fire Station
(vii) Regulatory Agency (AERB)

255
 (THIS IS THE ONLY APPENDIX FOR INDUSTRIAL
RADIOGRAPHY FACILITY)

APPENDIX-9E
(Refer section 3.7.5)

RADIATION PROTECTION MANUAL FOR INDUSTRIAL

RADIOGRAPHY FACILITY

Radiation protection manual (RPM) is an operation manual prepared specific to the

licensee’s organisation stating all operations relating to work with radiation and
identifying the tasks and the person(s) assigned to each task. The RPM ensures that
the licensee indeed works safely with radiation and determines how exactly safety
requirements will be fulfilled. The format of RPM is given bellow:
Contents of RPM
(a) Purpose and scope
(b) Organisational chart and responsibilities of persons
(c) Radiography source (gamma/X-ray) procurement
(d) Radiography source (gamma/X-ray) transport
(e) Radiography source (gamma) disposal
(f) Inventory of radiography equipment/radiation monitors
(g) Procedure for obtaining radiography site approval
(h) Standard operating procedure (SOP) for radiography work in respect
of open field (site radiography) and enclosed installations.
(i) Safety and security of radiography sources and devices at radiography
installations.
(j) Inspection and maintenance of radiography exposure devices
(IGRED /industrial X-ray) and associated accessories
(k) Maintenance and calibration of radiation monitors
(l) Emergency response plans and preparedness
(m) Submission of safety status reports (IU-6) to AERB
(n) Procedure for documentation :
(i) log-book, (ii) dose records (iii) IU-6 form
(o) Information and Training on radiation safety.

256
Example for Site Radiography:
Activity Responsible identified
Person(s)
1. Identification of IGRED/X-ray, area :
monitors, radiography personnel, radiation
protection accessories to be sent to
radiography site.
2. Confirmation of safe and secure source :
storage room
3. Source movement permission from AERB :
4. Shift of IGRED/X-ray machine with :
permission of AERB
5. Issuance of TLD badges to radiography :
personnel
6. Carrying IGRED/X-ray machine from source :
storage room to the location where
radiography job to be carried out
7. Set of radiography job :
8. Cordon the required area :
9. Operation of IGRED/X-ray machine :
10. Radiation monitoring around the cordon area :
11. Retract of radiography source into the source :
housing
12. Properly lock of the IGRED after completion :
of job
13. Removal of cordon :
14. Carrying of IGRED/X-ray machine to source :
storage room
15. Placement of IGRED in the source storage :
room
16. Return of TLD to RSO :
17. Storage of TLD badges securely :
18. Log-book entries :
19. Emergency plan and preparedness :
20. Site co-ordinator for safety and security :

257
 APPENDIX-10
(Refer section 3.18.1)

LIST OF AERB CODES, STANDARDS AND GUIDES USED FOR

RADIATION FACILITIES
Type of Approval/ AERB/Code/Standard/ Title
Radiation facility Guide No.
Industrial gamma AERB /RF-IR/ SS-1, ATOMIC ENERGY REGULA-
radiography exposure Rev-1 (2007) TORY BOARD, Safety Standard
devices for the Design and Construction of
Industrial Gamma Radiography
Exposure Devices and Source
Changers, AERB/RF-IR/SS-1,
Rev-1 (2007).
Industrial ionising AERB/SS-2, Rev. 1 (2001) ATOMIC ENERGY REGULA-
radiation gauging TORY BOARD, Standard
devices Specifications for Radiological
Safety in the Design and
Construction of Industrial Ionising
Radiation Gauging Devices,
AERB/SS-2, Rev. 1 (2001).
Sealed sources AERB/SS-3, Rev. 1 (2001) ATOMIC ENERGY REGULA-
TORY BOARD, Standard
Specifications for Testing and
Classification of Sealed
Radioactive Sources, AERB/SS-3,
Rev. 1 (2001).
Consumer products AERB/SS-4 (1990) ATOMIC ENERGY REGULA-
containing radioactive TORY BOARD, Standard
material Specification for Radiological
Safety in the Design and
Manufacture of Consumer
Products Containing Radioactive
Substances, AERB/SS-4 (1991).
X-ray analysis AERB/SS-5 (1992) ATOMIC ENERGY REGULA-
equipment TORY BOARD, Standard
Specifications for Radiological
Safety in the Design and
Manufacture of X-ray Analysis
Equipment, AERB/SS-5 (1992).
Land-based gamma AERB/RF-IRRAD/SS-6, ATOMIC ENERGY
radiation processing Rev.1 (2007) REGULATORY BOARD, Safety
plant other than gamma Standard for the Land-based
irradiation chambers Stationary Gamma Irradiators,
AERB/RF-IRRAD/SS-6, Rev.1
(2007)

258
 APPENDIX-10 (CONTD.)
(Refer section 3.18.1)

LIST OF AERB CODES, STANDARDS AND GUIDES USED FOR

RADIATION FACILITIES

Type of Approval/ AERB/Code/Standard/ Title

Radiation facility Guide No.
Land-based gamma AERB/SC/IRRAD (1993) ATOMIC ENERGY REGULA-
radiation processing TORY BOARD, Safety Code on
plant other than gamma Operation and Maintenance of
irradiation chambers Land-based Stationary Gamma
Irradiators. AERB/SC/IRRAD,
(1993).
Radiation therapy AERB/RF-MED/SC-1 ATOMIC ENERGY REGULA-
(Rev. 1) (2011) TORY BOARD, Safety Code for
Radiation Therapy Sources Equip-
ment and Installations, AERB/RF-
MED/SC-1 (Rev. 1) (2011).
Transport of radioactive AERB/SC/TR-1 (1986) ATOMIC ENERGY REGULA-
material TORY BOARD, Safety Code on
Transport of Radioactive
Materials, AERB/SC/TR-1
(1986).
Industrial radiography AERB/SC/IR-1(2001) ATOMIC ENERGY RGULA-
TORY BOARD, Safety Code on
Industrial Radiography, AERB/
SC/IR-1(2001)
AERB/SG/IN-1 (1986) ATOMIC ENERGY RGULATORY
BOARD, Safety Guide on
Radiological Safety in Enclosed
Radiography Installation, AERB/
SG/IN-1, 1986.
AERB/SG/IN-2 (1987) ATOMIC ENERGY RGULATORY
BOARD, Safety Guide on
Radiological Safety in Open Field
Industrial Radiography, AERB/SG/
IN-2, 1987.
AERB/SG/IN-3 (1989) ATOMIC ENERGY RGULATORY
BOARD, Safety Guide on Handling
of Emergencies in Industrial Radio-
graphy, AERB/SG/IN-3, 1989.

259
 APPENDIX-10 (CONTD.)
(Refer section 3.18.1)

LIST OF AERB CODES, STANDARDS AND GUIDES USED FOR

RADIATION FACILITIES

Type of Approval/ AERB/Code/Standard/ Title

Radiation facility Guide No.
Medical diagnostic X- AERB/RF-MED/SC-2 ATOMIC ENERGY REGULA-
ray equipment (Rev. 2) (2011) TORY BOARD, Safety Code for
Medical Diagnostic X-ray
Equipment and Installations,
AERB/SC/MED-2, Rev. 1 (2001).
Brachytherapy facilities AERB/SC/MED-3 (1988) ATOMIC ENERGY REGULA-
TORY BOARD, Safety Code for
Brachytherapy Sources, Equipment
and Installations, AERB/SC/
MED-3 (1988).
Nuclear medicine AERB/RF-MED/SC-2 ATOMIC ENERGY REGULA-
facilities (Rev. 2) (2011) TORY BOARD, Safety Code on
Nuclear Medicine Facilities AERB/
RF-MED/SC-2 (Rev. 2) (2011).

260
 BIBLIOGRAPHY

1. ATOMIC ENERGY ACT, 1962 (33 of 1962)

2. ATOMIC ENERGY(RADIATION PROTECTION ) RULES G.S.R. 303,
(2004).
3. ATOMIC ENERGY (SAFE DISPOSAL OF RADIOACTIVE WASTES)
RULES, G.S.R. 125, (1987).
4. ATOMIC ENERGY (CONTROL OF IRRADIATION OF FOOD) RULES,
G.S.R. 253, (1996).
5. ATOMIC ENERGY (FACTORIES) RULES, G.S.R. 254, (1996).
6. INDUSTRIAL RADIOGRAPHY (RADIATION SURVEILLANCE)
PROCEDURES G.S.R. 735, (1980)
7. RADIATION SURVEILLANCE PROCEDURES FOR TRANSPORT OF
RADIOACTIVE MATERIALS, (1987)
8. RADIATION SURVEILLANCE PROCEDURES FOR MEDICAL
APPLICATIONS OF RADIATION, G.S.R. 388, (1989).
9. ORDER CONSTITUTING ATOMIC ENERGY REGULATORY BOARD,
S.O. 4772, (1983).
10. ATOMIC ENERGY REGULATORY BOARD, Regulation of Nuclear and
Radiation Facilities, AERB Safety Code No. AERB/SC/G, Mumbai, India
(2000).
11. ATOMIC ENERGY REGULATORY BOARD, Safety Code on Emergency
Response Planning and Preparedness for Transport Accidents Involving
Radioactive Material. AERB/SC/TR-3, Mumbai, India (1990).
12. ATOMIC ENERGY REGULATORY BOARD, Safety Standard on ‘Industrial
Gamma Radiography Exposure Devices and Source Changers’, AERB Safety
Standard No. AERB/RF-IR/SS-1 (Rev. 1), Mumbai, India (2007).
13. ATOMIC ENERGY REGULATORY BOARD, Safety Standard on ‘Design
and Construction of Industrial Ionising Radiation Gauging Devices’, AERB
Safety Standard No. AERB/SS/2, Mumbai, India (2001).
14. ATOMIC ENERGY REGULATORY BOARD, Safety Standard on ‘Testing
and Classification of Sealed Radioactive Sources’, AERB Safety Standard
No. AERB/SS/3 (Rev. 1), Mumbai, India (2001).
15. ATOMIC ENERGY REGULATORY BOARD, Safety Standard on
‘Radiological Safety in the Design and Manufacture of Consumer products

Bi
 Containing Radioactive Substances’, AERB Safety Standard No. AERB/SS/
4, Mumbai, India (1991).
16. ATOMIC ENERGY REGULATORY BOARD, Safety Standard on
‘Radiological Safety in the Design and Manufacture of X-ray Analysis
Equipment’, AERB Safety Standard No. AERB /SS/5, Mumbai, India (1992).
17. ATOMIC ENERGY REGULATORY BOARD, Safety Standard on ‘Land
Based Stationary Gamma Irradiators’, AERB Safety Standard No. AERB/
RF-IRRAD/SS-6 (Rev. 1), Mumbai, India (2007).
18. INTERNATIONAL COMMISSION ON RADIOLOGICA PROTECTION,
ICRP-103, (2007).
19. INTERNATIOANL ATOMIC ENERGY AGENCY(IAEA), Safety Series No.
115, International Basic Safety Standards for Protection against Ionising
Radiation and for the Safety of Radiation Sources, Vienna (1996).
20. INTERNATIOANL ATOMIC ENERGY AGENCY (IAEA), Standards Series
No. TS-R-1, Regulations for the Safe Transport of Radioactive Material,
Vienna (2009).
21. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC),
Medical Electrical Equipment- Part-1: General Requirements for Basic Safety
and Essential Performance; IEC 60601-1 (2005)
22. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC),
Medical Electrical Equipment- Part-2-1: Particular Requirements for Safety
of Electron Accelerators in the Range of 1 MeV to 50 MeV IEC-60601-2-
1 (1998)
23. INTERNATIONAL ELECTROCHEMICAL COMMISSION (IEC), Medical
Electrical Equipment- Part-2 : Particular Requirements for the Safety of
Gamma Beam Therapy Equipment: IEC-60601-2-11 (1997).
24. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC),
Medical Electrical Equipment- Part-2: Particular Requirements for the Safety
of Automatically-Controlled Brachytherapy Afterloading Equipment; IEC-
60601-2-17 (2005).
25. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC),
Medical Electrical Equipment- Part 2-7: Particular Requirements for the
Safety of High-Voltage Generators of Diagnostic X-Ray Generators; IEC-
60601-2-7 (1998).
26. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC),
Medical Electrical Equipment- Part-2: Particular Requirements for the Safety
of Associated Equipment of X-Ray Equipment; IEC-601-2-32 (1994).

Bii
27. BUREAU OF INDIAN STANDARDS (BIS), Specifications for Diagnostic
Medical X-ray Equipment, Part-1: General and Safety Requirements, IS-
7620 (1986).
28. BUREAU OF INDIAN STANDARDS (BIS), Specifications for Diagnostic
Medical X-ray Equipment, Part-2: Performance Requirements, IS-7620
(1986).
29. BUREAU OF INDIAN STANDARDS (BIS), Specifications for Diagnostic
Medical X-ray Equipment, Part-3: Radiation Safety Requirements, IS-7620
(1991).
30. BUREAU OF INDIAN STANDARDS (BIS), Specifications for Dental X-
ray Equipment, Radiation Safety Requirements, IS-13709 (1993).
31. NATIOANAL BUREAU OF STANDARDS, NBS Handbook-127, American
National Standards N433.1, Safe Design and Use of Self Contained, Dry
Source Storage Gamma Irradiators (Category-I) (1979).
32. NATIOANAL BUREAU OF STANDARDS, NBS Handbook-142, American
National Standards N43.10, Safe Design and Use of Panoramic, Wet Source
Storage Gamma Irradiators (Category-IV) (1984).
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Requirements and Classification; ISO 2919:1999 (E) (1999).
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Sources - Leakage Test Methods; ISO 9978:1992 E (1992).
35. INTERNATIONAL STANDARD, Apparatus for Gamma Radiography-
Specification ISO 3999 (2000).
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for Permanent Installation, ISO-7205 (1986).

Biii
 LIST OF PARTICIPANTS

DRAFT DOCUMENT PREPARED BY (1994-2006)

Late Dr. I.S. Sundara Rao : AERB (Former)

Shri K.D. Pushpangadan : AERB (Former)
Shri T.N. Krishnmurthi : AERB (Former)

DRAFT DOCUMENT FULLY REVISED (2008-2009)

WORKING GROUP

Dates of meeting: August 21, 25, 26, 2008

September 8, 9, 15, 25, 30, 2008
October 1, 2008
November 6, 7, 2008
December 1, 2, 3, 4, 5, 8, 11, 12, 29, 2008
January 13, 27, 2009
February 3, 4, 5, 11, 12, 13, 17, 18, 2009
March 2, 3, 2009
April 11, 12, 13, 2009
May 7, 8, 13, 14, 15, 18, 19, 21, 22, 2009

Shri S.T. Swamy (Convenor) : AERB

Dr. R.M. Nehru : AERB
Shri A.U. Sonawane : AERB
Shri R. Kannan : AERB
Shri R.P. Gupta : AERB
Dr. P.K. Dash Sharma : AERB
Shri R.K. Singh : AERB
Shri Suneet K. : AERB
Smt. Bharati I. : AERB
Smt. Anuradha V. (Member-Secretary) : AERB

Li
 LIST OF PARTICIPANTS

ACKNOWLEDGEMENTS (2008-2010)
(for contributions in revision of document)

Shri S.A. Hussain : AERB

Shri V.K. Shirva : AERB (Retd.)
Smt B. Nagalakshmi (Retd) : AERB (Retd.)
Dr. P.K. Tandon : AERB
Shri V.S. Iyer : AERB
Shri Brijesh K. Singh : AERB
Shri Dinesh M. Rane : AERB
Shri Ghanshyam Sahani : AERB
Shri Pravin Patil : AERB
Shri Soumen Sinha : AERB
Shri M. Senthil Kumar : AERB
Smt. Manisha Inamdar : AERB
Shri Nidhip M.Chodankar : AERB
Shri Amit Sen : AERB
Kum. Arti Kulkarni : AERB
Shri Neeraj Dixit : AERB
Shri R.K. Chaturvedi : AERB
Shri Bibek Mishra : AERB

CONSISTENCY CHECK (APRIL - JULY 2010)

Shri. K. Srivasista : AERB

Lii
 ADVISORY COMMITTEE ON PREPARATION OF CODES,
GUIDES AND MANUALS ON GOVERNMENTAL
ORGANISATION FOR NUCLEAR AND RADIATION
FACILITIES (ACCGORN)

Dates of meeting: January 23, 1998 February 10, 1998

June 17, 1999 July 12, 1999
October 5 & 6, 2000 October 17, 2000
April 1, 2005 August 4, 2006
September 25 & 26, 2006 October 5, 2006
November 24, 2007 July 4, 2008
August 7 & 8, 2008 November 28, 2008

Chairman, Members and Invitees of ACCGORN:

Late Dr. S.S. Ramaswamy, Chairman : Director General, Factory Advice

(till January 2003) Director General, Factory Advice
Service and Labour Institute
(FASLI) (Former)
Shri G.R. Srinivasan, Chairman : Vice Chairman, AERB (Former)
(Since February 2003)
Shri G.V. Nadkarny : NPCIL (Former)
Shri A.K. Asrani : AERB (Former)
Shri T.N. Krishnamurthi : AERB (Former)
Late Dr. I.S. Sundara Rao : AERB (Former)
Shri N.K. Jhamb : AERB (Former)
Dr. K.S. Parthasarthy : AERB (Former)
Shri P.K. Ghosh : AERB (Former)
Shri G.K. De : AERB (Former)
Shri Deepak De : AERB (Former)
Shri P. Hajra : AERB (Former)
Shri R. Venkataraman : AERB (Former)

Liii
 ADVISORY COMMITTEE ON PREPARATION OF CODES,
GUIDES AND MANUALS ON GOVERNMENTAL
ORGANISATION FOR NUCLEAR AND RADIATION
FACILITIES (ACCGORN) (Contd.)

Chairman, Members and Invitees of ACCGORN (Contd.):

Shri S.P. Agarwal : AERB (Former)

Shri S.K. Chande : AERB
Dr. S.K. Gupta : AERB
Dr. P.C. Basu : AERB
Shri R.I. Gujrathi : AERB
Dr. Ompal Singh : AERB
Shri R. Bhattacharya : AERB
Shri Y.K. Shah (Member Secretary) : AERB
Shri S.T. Swamy (Permanent Invitee) : AERB
Smt. V. Anuradha (Permanent Invitee) : AERB

Liv
PROVISIONAL LIST OF CODES, GUIDES AND MANUALS
FOR REGULATION OF NUCLEAR AND RADIATION
FACILITIES

Safety Series No. Titles

AERB/SC/G Regulation of Nuclear and Radiation Facilities

AERB/NPP&RR/ Consenting Process for Nuclear Power Plants and
SG/G-1 Research Reactors
AERB/NF/SG/G-2 Consenting Process for Nuclear Fuel Cycle Facilities and
Related Industrial Facilities other than Nuclear Power
Plants and Research Reactors
AERB/RF/SG/G-3 Consenting Process for Radiation Facilities
AERB/SG/G-4 Regulatory Inspection and Enforcement in Nuclear and
Radiation Facilities
AERB/SG/G-5 Role of AERB with respect to Emergency Response and
Preparedness at Nuclear and Radiation Facilities
AERB/SG/G-6 Codes, Standards and Guides to be Prepared by the AERB
for Nuclear and Radiation Facilities
AERB/SG/G-7 Regulatory Consents for Nuclear and Radiation Facilities:
Contents and Formats
AERB/SG/G-8 Criteria for Regulation of Health and Safety of Nuclear
Power Plant Personnel, the Public and the Environment
AERB/NPP&RR/ Regulatory Inspection and Enforcement in Nuclear
SM/G-1 Power Plants and Research Reactors
AERB/NF/SM/G-2 Regulatory Inspection and Enforcement in Nuclear Fuel
Cycle and Related Industrial Facilities other than
Nuclear Power Plants and Research Reactors
AERB/RF/SM/G-3 Regulatory Inspection and Enforcement in Radiation
Facilities

Pi
AERB SAFETY GUIDE NO. AERB/RF/SG/G-3 (Vol. 2 of 4)

Published by : Atomic Energy Regulatory Board

Niyamak Bhavan, Anushaktinagar
Mumbai - 400 094
INDIA. BCS