REGISTERED No.

M - 302
L.- 7646

The Gazette of Pakistan

EXTRAORDINARY
PUBLISHED BY AUTHORITY

ISLAMABAD, TUESDAY, OCTOBER 5, 2004

PART II

Statutory Notification (S. R. O.)

GOVERNMENT OF PAKISTAN

PAKISTAN NUCLEAR REGULATORY AUTHORITY

NOTIFICATION

Islamabad, the 5th October, 2004

S.R.O. 837(I)/2004. In exercise of the powers conferred by Section 56 of the Pakistan

Nuclear Regulatory Authority Ordinance, 2001(III of 2001), the Pakistan Nuclear Regulatory
Authority is pleased to make and promulgate the following regulations:—
1. Short title and commencement. — (1) These regulations may be called
"Regulations on Radiation Protection (PAK/904)".
(2) These regulations extend to the whole of Pakistan.
(3) These regulations shall come into force at once.
2. Definitions. In these regulations, unless there is anything repugnant in the
subject or context, —
(a) "accident" means any unintended event, including operating errors,
equipment failures or other mishaps, the consequences or potential
consequences of which are not negligible from the point of view of
protection or safety.
(b) “applicant” means any person who applies to the Authority for a
license or/and authorization to under take specified activities.
(c) "Authority" means the Pakistan Nuclear Regulatory Authority
established under section 3 of the Ordinance.
(d) "authorization" means an authorization granted under section 20 or, as
the case may be, sections 21, 22 or 23 of the Ordinance.
(e) "clearance" means the removal of radioactive materials or radioactive
objects within licensed/authorized practices from any further
regulatory control by the Authority.
(f) "consumer product" means device such as smoke detector, luminous dial
or ion generating tube that contains a small amount of radioactive
substance.
(g) "controlled area" means a defined area in which specific protection
measures and safety provisions are or could be required for controlling
normal exposures or preventing the spread of contamination during
normal working conditions, and preventing or limiting the extent of
potential exposures.
(h) "critical group" means a group of members of the public which is
reasonably homogeneous with respect to its exposure for a given radiation
source and given exposure pathway and is typical of individuals receiving
the highest effective dose or equivalent dose (as applicable) by the given
exposure pathway from the given source.
(i) "defence in depth" means a hierarchical deployment of different levels of
equipment and procedures in order to maintain the effectiveness of
physical barriers placed between a radiation source or radioactive
materials and workers, members of the public or the environment, in
operational states and, for some barriers, in accident conditions.
(j) “dose constraint” means a prospective restriction on the individual dose
delivered by a source, which serves as an upper limit on the dose in
optimization of protection and safety for the source.
(k) "dose limit" means the value of the effective dose or the equivalent dose
to individuals from controlled practices that shall not be exceeded.
(l) "effective dose, E" means the quantity E, defined as a summation of the
tissue equivalent doses, each multiplied by the appropriate tissue
weighting factor:

E = ∑ wT ⋅ HT
T

where HT is the equivalent dose in tissue T and wT is the tissue weighting

factor for tissue T. From the definition of equivalent dose, it follows that:

E = ∑ w T ⋅ ∑ w R ⋅ D T,R
T R

where wR is the radiation weighting factor for radiation R and DT,R is the
average absorbed dose in the organ or tissue T.
(m) "equivalent dose, HT " means the quantity HT,R, defined as:
H T,R = w R ⋅ D T,R

where DT,R is the absorbed dose delivered by radiation type R averaged

over a tissue or organ T and wR is the radiation weighting factor for
radiation type R. When the radiation field is composed of different
radiation types with different values of wR the equivalent dose is:
 HT=∑wR⋅D
R

(n) “Exposure” means the act or condition of being subject to irradiation.

Exposure can be either external exposure (irradiation by source outside
the body) or internal exposure (irradiation by source inside the body).
Exposure can be classified as either normal exposure or potential
exposure; occupational, medical or public exposure; and, in
intervention situations, either emergency exposure or chronic
exposure. The term exposure is also used in radiodosimetry to express
the amount of ionization produced in air by ionizing radiations.
(o) "guidance level" means a level of a specified quantity above which
appropriate actions shall be considered. In some circumstances, actions
may need to be considered when the specified quantity is substantially
below the guidance level.
(p) "health professional" means an individual who has been accredited
through appropriate national procedures to practice a profession related
to health (e.g. nursing, medical physics, radiation and nuclear
medical technology, radiopharmacy, occupational health).
(q) "health surveillance" means medical supervision intended to ensure the
initial and continuous fitness of workers for their intended task.
(r) "intervention" means any action intended to reduce or avert exposure or
the likelihood of exposure to sources which are not part of a controlled
practice or which are out of control as a consequence of an accident.
(s) "licensee" means the holder of a current license.
(t)
"limit" means the value of a quantity used in certain specified activities or
circumstances that must not be exceeded.
(u) "medical exposure" means exposure incurred by patients as part of their
own medical or dental diagnosis (diagnostic exposure) or treatment
(therapeutic exposure); by persons, other than those occupationally
exposed, knowingly exposed while voluntarily helping in the support and
comfort of patients; and by volunteers in a programme of biomedical
research involving their exposure.
(v) "medical professional" means an individual who: (a) has been accredited
through Pakistan Medical and Dental Council (PMDC) as a registered
medical practitioner or registered dental surgeon; and (b) fulfills the
requirements of training and experience as approved by the Authority;
(w) "member of the public" means, in a general sense, any individual in the
population except, for protection and safety purposes, when subject to
occupational or medical exposure. For the purpose of verifying
compliance with the annual dose limit for public exposure, the
representative individual in the relevant critical group.
(x) "monitoring" means the measurement of dose or contamination for
reasons related to the assessment or control of exposure to radiation or
radioactive substances, and the interpretation of the results.
1
[(xx) "natural background" means the doses, dose rates or activity concentrations
associated with natural sources or any other sources in the environment that
are not amenable to control.]

1 As amended vide S.R. O. 808(I)/2019 dated July 12, 2019.

(y) "normal exposure" means exposure which is expected to occur under the
normal operating conditions of a facility or activity, including possible
minor mishaps that can be kept under control, i.e. during normal operation
and anticipated operational occurrences.
(z) "occupational exposure" means all exposure of workers incurred in the
course of their work, with the exception of excluded exposures and
exposures from exempt practices or exempt sources.
(aa) "optimization" means the process of determining what level of protection
and safety makes exposures, and the probability and magnitude of
potential exposures, “as low as reasonably achievable, economic and
social factors being taken into account” (ALARA).
(bb) "Ordinance" means the Pakistan Nuclear Regulatory Authority Ordinance,
2001(III of 2001).
(cc) "potential exposure" means exposure that is not expected to be delivered
with certainty but that may result from an accident at a source or owing to
an event or sequence of events of a probabilistic nature, including
equipment failures and operating errors.
(dd) "practice" means 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.
(ee) "protection and safety" means the protection of people against exposure to
ionizing radiation or radioactive materials and the safety of radiation
sources, including the means for achieving this, and the means for
preventing accidents and for mitigating the consequences of accidents
should they occur.
(ff) "protective action" means an intervention intended to avoid or reduce
doses to members of the public in chronic exposure or emergency
exposure situations.
(gg) "public exposure" means exposure incurred by members of the public
from radiation sources, excluding any occupational or medical exposure
and the normal local natural background radiation but including exposure
from authorized sources and practices and from intervention situations.
(hh) "qualified expert" means an individual who, by virtue of certification by
appropriate boards or societies, professional licences or academic
qualifications and experience, is duly recognized as having expertise in a
relevant field of specialization, e.g. medical physics, radiation protection,
occupational health, fire safety, quality assurance or any relevant
engineering or safety speciality.
(ii) "quality assurance (QA)" means planned and systematic actions necessary
to provide adequate confidence that an item, process or service will satisfy
given requirements for quality, for example, those specified in the licence.
(jj) "Radiation Protection Officer (RPO)" means an individual technically
 competent in radiation protection matters relevant for a given type of
practice who is designated by the licensee to oversee the application of the
requirements of these regulations.
(kk) "reference level" means action level, intervention level, investigation level
or recording level.
(ll) "safety assessment" means assessment of all aspects of the siting, design
and operation of an authorized facility which are relevant to protection
and safety.
(mm) "safety culture" means the assembly of characteristics and attitudes in
organizations and individuals which establishes that, as an overriding
priority, protection and safety issues receive the attention warranted by
their significance.
(nn) "sealed source" means radioactive material that is (i) permanently sealed
in a capsule or (ii) closely bonded and in a solid form.
(oo) "security" means measures to prevent unauthorized access to, and loss,
theft or unauthorized transfer of radiation sources or radioactive material.
(pp) "source" means anything that may cause radiation exposure, such as by
emitting ionizing radiation or by releasing radioactive substances or
materials, and can be treated as a single entity for protection and safety
purposes.
(qq) "supervised area" means a defined area not designated a controlled area
but for which occupational exposure conditions are kept under review,
even though specific protection measures and safety provisions are not
normally needed.
(rr) "unsealed source" means a source that does not meet the definition of a
sealed source.
(ss) "worker" means any individual who works, whether full time, part time or
temporarily, for an employer and who has recognized 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).

GENERAL PROVISION

3. Scope. These regulations shall apply to the following activities:

(a) acquisition, design, manufacture, construction, installation or operation of

any device that contains any radioactive material or produce ionizing
radiation including consumer products, sealed sources, unsealed sources
and radiation generators including, mobile radiography equipment;
(b) establishment of installations and facilities which contain radioactive
materials or devices which produce radiation including irradiation
facilities, mines and mills processing radioactive ores, installations
processing radioactive substances, nuclear installations and radioactive
waste management facilities;
(c) exploration for mining and milling, extraction, acquisition, handling, use
for medical, industrial, veterinary, or agriculture purposes, or for
 education, training or research, etc., selling, leasing, lending, buying,
transferring, import, export, conversion, enrichment, production, storage,
processing, reprocessing, fabrication, transportation, disposal of any
radioactive ores, radioactive material, nuclear substance or any other
substance as the Authority may, by notification in the official Gazette,
specify;
(d) treatment of food by ionizing radiation; and
(e) any other source or practice as specified by the Authority.

4. Interpretation..The decision of Chairman, PNRA regarding the interpretation

of any word or phrase of these regulations or applicability of these regulations shall be final and
binding on the licensee.

5. Exclusions. The following exposures are excluded from the requirements of

these regulations:
(a) exposures from natural radioactivity in the body;
(b) exposures from cosmic radiation at the surface of the earth;
(c) exposures from unmodified concentrations of radionuclides in raw
materials; and
(d) exposures from any other sources that are essentially unamenable to
control as may be determined by the Authority.

6. Non-compliance. (1) In the event of a breach of any applicable requirement

of these regulations, the licensee shall, as appropriate:

(a) investigate the breach and its causes, circumstances and consequences;
(b) take appropriate action to remedy the circumstances and to prevent a
recurrence of similar situations;
(c) communicate to the Authority, as a matter of priority, on the causes of the
breach, its circumstances and consequences, and on the corrective or
preventive actions taken or to be taken; and
(d) take whatever other actions are necessary as required by these regulations.

(2) The communication of a breach to the Authority shall be timely (with in 24 hours)
and it shall be immediate whenever an emergency exposure situation has developed or is
developing.

(3) Failure to take corrective or preventive actions within a reasonable time in

accordance with these regulations shall be grounds for modifying, suspending or withdrawing
any license or/and authorization that has been granted by the Authority.

ADMINISTRATIVE REQUIREMENTS

7. Exemptions. (1) Practices and sources within practices may be exempted from
the requirements of these regulations if the Authority is satisfied that the sources meet the
exemption criteria:

(a) the effective dose expected to be incurred by any member of the public due to the
exempted practice or source is of the order of 10 µSv or less in a year,
 (b) either thhe collecttive effecttive dose committeed by one year of pperformannce of thee
practicee is no moore than aabout 1 maan.Sv or aan assessm ment for tthe optimiization off
protectiion shows that exem mption is tthe optimuum optionn.

or tthe exempption levvels speciified in A Annex I or other exemptioon levels specifiedd by thee
Authhority on the basis of these eexemptionn criteria.

(2) Exempttions shalll not be grranted forr practicess deemed nnot to be jjustified.

(3) The folllowing prractices annd sources within a practice are autom
matically exemptedd
from thhe requirrements oof these regulatioons, incluuding thee requirem ment forr
notificaation, licennsing and authorizaation
(a) radioacttive substtances forr which thhe total acctivity off a given nnuclide ppresent onn
the prem
mises at aany one tiime or its activity cconcentraation contained in a mass off
1000 kgg or less of materiial does nnot exceeed the exeemption llevels speecified in
Annex II;
(b) apparatuus contaaining raadioactive substannces exceeding tthe quanntities orr
concenttrations sppecified abbove, provvided thatt:

(i) it is of a tyype approoved by thhe Authoriity; and

(ii) it is consttructed inn the form
m of a seaaled sourcce, and it does not cause, inn
normal opperating cconditionss, a dose rrate exceeeding 1 µSSv·h-1 at a
distance of 0.1 m from anyy accessibble surfacce of the aapparatus nor a
dose to aany membber of the public exxceeding 110 µSv in a year; orr

(c) the operration of any electtrical appaaratus to which theese regulaations appply, otherr
than thaat referredd in sub-cllause (d) bbelow, proovided thaat:

(i) it is of a tyype approoved by thhe Authoriity; and

(ii) it does noot cause iin normall operatinng conditions a dosse rate exxceeding
1 µSv·h-1 at a disstance of 0.1 m ffrom any accessibble surfacce of the
apparatuss; or

(d) the operration of aany cathoode ray tubbe intendeed for thee display oof visual iimages orr
other electrical appparatus ooperating at a potential diffeerence nott exceedinng 30 kV,,
provideed that it does noot cause in normaal operatiing condiitions a ddose ratee
exceeding 1 µSvv·h-1 at a ddistance oof 0.1 m from anyy accessibble surfacce of the
apparatuus.
8. Licen nsing. The applicannt shall fulfill tthe requuirements specified in thhe
‘Regulations for the Licensing oof Nucleaar Installattions in Pakistan- P PAK/909’ or ‘Reguulations foor
the Licensingg of Radiaation Facillity(ies) oother than Nuclear IInstallation(s)- PAKK/908’.

9. Designaation/Employmentt of RPO/ Health Professsional/ Medical

Proofessional.. The licensee shall deesignate/em mploy ann RPO/H Health Prrofessionaal/Medicall
Proffessional aas deems necessaryy and fulffilling thee basic quualificatioon criteria establishhed by thee
Authhority forr the acccomplishmment of tthe requirrement oof these regulationns. 2 [Thee licenseee
shalll designaate/employyee a Raddiation Prootection OOfficer (R
RPO)/ Heaalth Profeessional / Medicall
Proffessional as deems necessaary fulfillling the bbasic quaalificationn and trainning criteeria givenn
in AAnnexuree-VII of thhese regulaations.]

10. Respon nsibilities of the liccensee. (1) The licensee shall bearr the responsibilityy
for eestablishinng and im
mplementiing the tecchnical annd organizzational m
measures tthat are needed forr

2 Ass amended vide S.R.O

O.836(I)/20
004 dated October 0
05, 2004
ensuuring proteection andd safety ffor the praactices annd sourcess for whicch they arre licenseed and forr
com
mpliance w with all appplicable requirem ments of thhese reguulations. T They mayy appoint and shalll
speccifically iddentify otther peoplle to carryy out actiions and ttasks relatted to theese responnsibilities,,
but tthey shalll retain thee responsiibility for the actionns and tassks themseelves.

(2) The liccensee shhall notifyy to the Authoritty of theeir intenttions to iintroduce
moddificationss to any ppractice orr source ffor which they are licensed wheneverr the moddificationss
coulld have significantt implicattions for pprotectionn or safetty, and shhall not ccarry out any suchh
moddification uunless speecifically authorizeed by the A
Authority.

(3) The liceensee shalll ensure tthat only workers w who are ddesignatedd in the appplicationn
by nname and qualificaation credentials annd permittted by refference inn the licennse, as haaving keyy
assiggnments related too protecttion and safety, aand otherr workerss assigned tasks iinvolvingg
operration or hhandling oof radiatioon sourcees which ccould substantially affect prootection aand safetyy
shalll be permiitted to unndertake aand fulfilll such requuired assignments aand tasks..

11. Clearan nce. T

The licenssee can aapply for the clearrance of sources, includingg
subsstances, m
materials aand objects within liicensed or authorizzed practicces from ffurther coompliancee
withh the requirements of these rregulationns provideed that theey complyy with the exemptioon criteriaa
as sppecified inn regulatioon no. 7 oor approveed by the A
Authorityy.

12. Radionuclide coontaminaation leveels in edible good ds. (1) No perrson shalll
import any eddible goodds withouut a certifiicate from
m the relevvant authoority of thhe countryy of originn
of thhe goods to the eeffect thatt the radiionuclide levels inn the goodds are noot more thhan thosee
speccified in A
Annex II.

(2) No person shall pproduce, m manufactuure or otherwise preepare, stoore, sell orr offer forr
sale any edibble goods in whichh the radioonuclide llevels aree more thaan the levvels presccribed in
Annnex II.
3
[12. Radion nuclide Contaminaation in C Commodiities.—(1) Production, manuufacturingg
or ootherwisee preparattion, storrage, salee, import,, and expport of eedible gooods in w which thee
radionuclide llevels aree more thaan the leveels prescriibed in Annnex II shhall be proohibited.

(2) The Auuthority m may requuire, as aand whenn deemed necessarry, from a personn
importing ediible goodds to furniish a certiificate issuued by thhe relevantt authorityy of the ccountry off
origgin specifyying radioonuclide leevels pressent in thee edible goods and that thesee are not mmore thann
thosse specifieed in Anneex II.

(3) Unless exempted by thee Authoriity, produuction, m manufactuuring or otherwisee

prepparation, sstorage, ssale, impoort, and export of scrap mettal, recyccled metall productss or otherr
com
mmodities having raadiation leevels abovve the natuural backgground shhall be proohibited.

(4) The perrson impoorting scrrap metall and recyycled mettal produucts shall furnish a
certiificate isssued by thhe relevannt authorityy of the ccountry off origin sppecifying tthe radiattion levelss
in thhe scrap. A An underttaking shaall also bee furnisheed that if aany imporrted consiignment iss found too
havee radiationn levels hhigher thaan the natuural backkground leevels, thenn the sam me shall bee returnedd
backk to the coountry of origin at hhis own riisk and coost.

(5) All suchh consignm ments, shipments aand contaiiners may be subjecct to verifi
fication byy
the concerned local aauthoritiess. Whereaas, any im mported cconsignmeent, shipm ment and containerr
haviing radiattion levelss higher tthan the nnatural baackgroundd levels shhall be reeturned baack to thee
counntry of oriigin at thee cost of cconsignee..

(6) The Auuthority m

may imposse restrictiions on im
mport of edible gooods, and any otherr
speccific goodds or commmodities from a specific country,, for a sppecific tiime, undeer speciall
circuumstances.]

3 As amended vide S.R.O

O.808(I)/20
019 dated July 12, 20
019
RADIATION PROTECTION PERFORMANCE REQUIREMENTS

13. Justification of practices. (1) No practice shall be licensed or authorized

unless it produces sufficient benefit to individuals to be exposed or to society to offset the
radiation harm that it might cause, taking into account social, economic and other relevant
factors. For this decision, the applicant for a license or authorization shall provide sufficient
information and evidence on the benefits and the harm to support the justification of the practice.

(2) The following practices shall be deemed to be not justified whenever they are
likely to result in an increase, by deliberate addition of radioactive substances or by activation, in
the activity of the associated commodities or products:

(a) except for justified practice involving medical exposures, practices involving
food, beverages, cosmetics or any other commodity or product intended for
ingestion, inhalation or percutaneous intake by, or application to, a human being;
(b) practices involving the frivolous use of radiation or radioactive substances in
commodities or products such as toys and personal jewellery or adornments; and
(c) any other practice so determined by the Authority.

14. Dose limitation. The normal exposure of individuals shall be restricted so that
neither the total effective dose nor the total equivalent dose to relevant organs or tissues, caused
by the possible combination of exposures from licensed or/and authorized practices, exceeds any
relevant dose limit specified in Annex III except in the special circumstances considered in
regulation no. 34. Dose limits shall not apply to medical exposures from authorized practices.

15. Optimization of protection and safety. In relation to exposures from any

particular source within a practice, radiation safety shall be optimized in order that the magnitude
of individual doses, except for therapeutic medical exposures, the number of people exposed and
the likelihood of incurring exposures all be kept as low as reasonably achievable (ALARA),
economic and social factors being taken into account, within the restriction that the dose to
individuals delivered by the source be subject to dose constraints. The licensee shall use, to the
extent practicable, procedures and engineering controls based upon sound radiation safety
principles to achieve this objective.

16. Dose constraints. (1) Except for medical exposure, the optimisation of the
radiation safety measures associated with a given practice shall satisfy the condition that the
resulting doses to the individuals of the critical group do not exceed dose constraints which are
equal to the dose limits specified in Annex III or any lower values agreed by the Authority.

(2) In case of any source that can release radioactive substances to the environment,
the dose constraints (fraction of the dose limit) shall be established so that the prospective annual
doses to members of the public, including people distant from the source and people of future
generations, summed over all exposure pathways, including contribution by other practices and
sources, are unlikely to exceed the dose limits specified in Annex III.

MANAGEMENT AND TECHNICAL REQUIREMENTS

17. Safety Culture. The licensee shall establish a management system,

commensurate with the size and nature of the licensed/authorized activity, which ensures that:

(a) policies and procedures are established that identify protection and safety as being
of the highest priority;
(b) problems affecting protection and safety are promptly identified and corrected
in a manner commensurate with their importance;
(c) the responsibilities of each individual for protection and safety are clearly
identified and each individual is suitably trained and qualified;
(d) clear lines of authority for decisions on protection and safety are defined; and
(e) organizational arrangements and lines of communications are established that
result in an appropriate flow of information on protection and safety at and
between the various levels in the entire organization of the licensee.
 18. Quality Assurance. The licensee shall establish quality assurance programmes
that provide, as appropriate:

(a) adequate assurance that the specified requirements relating to protection

and safety are satisfied; and
(b) quality control mechanisms and procedures for reviewing and assessing the
overall effectiveness of protection and safety measures.

19. Human Factors. (1) The licensee shall ensure that all personnel on whom
protection and safety depend are appropriately trained and qualified so that they understand their
responsibilities and perform their duties with appropriate judgement and according to defined
procedures, and are periodically retrained or re-qualified as may be appropriate.

(2). The licensee, in co-operation with suppliers as appropriate, shall follow sound
ergonomic principles in designing equipment and preparing operating procedures, in order to
facilitate the safe use of equipment and minimize the contribution of human errors to accidents
or incidents.

(3) The licensee shall provide appropriate equipment, safety systems and procedures
which:

(a) reduce, as far as practicable, the possibility of human errors leading to unplanned
exposure of any person;
(b) provide means to detect human errors and correct or compensate for them; and
(c) facilitate intervention in the event of an accident.

20. Security and Accountability of Sources. (1) Sources shall be kept secure so
as to prevent loss, theft, damage and to prevent any unauthorized transfer or access to the
sources.

(2) The licensee shall maintain an accountability system that includes records of:

(a) the location and description of each source for which they are responsible; and
(b) the activity and form of each radioactive substance for which they are responsible.

(3) The licensee shall make arrangements for the sources under their responsibility to
be kept secure by ensuring that:

(a) control of a source is not relinquished without compliance with all relevant
requirements specified in the license and without immediate communication to
the Authority of information regarding any decontrolled, lost, stolen or missing
source;
(b) a source is not transferred unless the receiver possesses a valid license
or authorization from the Authority;
(c) records are maintained of source inventory, including records of receipt, transfer
and disposal of sources; and
(d) a periodic inventory of sources is conducted at intervals specified in the license to
confirm that they are in their assigned locations and are secure.

21. Defence in depth. A multilayer (defence in depth) system of provisions for

protection and safety shall be applied to sources such that a failure at one layer is compensated
for or corrected by subsequent layers.

VERIFICATION OF PROTECTION AND SAFETY

22. Safety assessments. Safety assessments related to protection and safety

measures for sources within practices shall be made by the licensee at different stages, including
siting, design, manufacture, construction, installation, commissioning, operation, maintenance
and decommissioning.
 23. Monitoring and verification of compliance. (1) The licensee shall conduct
monitoring and measurements of the parameters necessary for verification of compliance with
the requirements of these regulations and licence.

(2) For the purposes of monitoring and verification of compliance, suitable equipment
shall be provided and verification procedures introduced by the licensee. The equipment shall be
properly maintained and tested and shall be calibrated at appropriate intervals with reference to
standards traceable to national or international standards.

24. Records. Records shall be maintained by the licensee of the results of

monitoring and verification of compliance, including records of the tests and calibrations carried
out in accordance with requirements of these regulations.

OCCUPATIONAL EXPOSURE PROTECTION

25. General responsibilities. (1) The licensee who is engaged in activities that
involve or could involve occupational exposure shall be responsible for the protection of the
workers against any occupational exposure which is not excluded from these regulations.

(2) The licensee shall ensure, for all workers engaged in activities that involve or
could involve occupational exposure that:

(a) occupational exposures are limited as specified in Annex III;

(b) radiation safety is optimized in accordance with regulation nos. 15 and 16;
(c) policies, procedures and organizational arrangements for occupational protection
and safety are established to implement the relevant requirements of these
regulations and the resulting decisions on measures to be adopted for this purpose
are recorded and made available to relevant parties including workers;
(d) suitable and adequate facilities for radiation safety are provided, including
personal protective devices and radiation monitoring equipment, and
arrangements are made for their proper use;
(e) radiation safety and health surveillance services are provided through qualified
experts;
(f) arrangements are made to facilitate better coordination with workers on all
measures which are needed to achieve adequate radiation safety by an effective
implementation of these regulations; and
(g) necessary conditions are provided and arrangements are made to promote a safety
culture in the work force and achieve adequate training of workers on radiation
safety matters.

(3) If workers are to be engaged in work that involves or could involve a source
which is not under the control of their employer, the licensee responsible for the source shall:

(a) obtain from the employer, as a pre-condition for engagement of such workers,
information on their previous occupational exposure history and other information
as may be necessary to provide protection and safety in compliance with these
regulations;
(b) provide such workers with protective measures and safety provisions which are at
least as good as those provided for employees of the licensee; and
 (c) make dosimetric and other appropriate information available to the employer for
the purpose of demonstrating that the level of protection provided to such workers
is compatible with the requirements of these regulations.

(4) The licensee shall ensure that workers under their responsibility who are exposed
to radiation from sources, other than natural sources, that are not directly related to or required
by their work receive the same level of protection as if they were members of the public.

(5) The licensee shall ensure that workers are informed of their obligations and
responsibilities for their own protection and the protection of others against radiation and for the
safety of sources. In particular, the licensee shall ensure that workers:

(a) follow applicable rules and procedures for protection and safety;
(b) properly use the monitoring devices and the protective equipment and clothing
provided;
(c) abstain from any willful action that could put themselves or others in situations
that contravene the requirements of these regulations; and
(d) promptly report to the licensee, any circumstances that could adversely affect
safety conditions or the requirements of these regulations.

(6) The licensee shall record any report received from a worker that identifies any
circumstances that could affect safety conditions or compliance with the requirements of these
regulations, and shall take appropriate remedial action.

26. Conditions of service. (1) The conditions of service of workers shall be

independent of the existence or the possibility of occupational exposure. Special compensatory
arrangements or preferential treatment with respect to salary or special insurance coverage,
working hours, length of vacation, additional holidays or retirement benefits shall neither be
granted nor be used as substitutes for the provision of proper protection and safety measures to
ensure compliance with the requirements of these regulations.

(2) Female workers shall be advised by the licensee that it is desirable to notify the
licensee of pregnancy. Once a female worker has notified the licensee that she is pregnant, the
licensee shall adapt the working conditions in respect of occupational exposure so as to ensure
that the embryo or foetus is afforded the same broad level of protection which is required for
members of the public, as is specified in Annex III. The notification of pregnancy shall not be
considered a reason to exclude a female worker from work.

(3) The licensee shall make every reasonable effort to provide workers with suitable
alternative workplace or employment in circumstances where it has been determined either by
the Authority or in the framework of health surveillance programme required by these
regulations that the worker, for health reasons, may no longer continue in employment involving
occupational exposure.

(4) No individual under the age of sixteen (16) years shall be subjected to
occupational exposure. No individual under the age of eighteen (18) years shall be allowed to
work in a controlled area unless supervised and then only for the purpose of the training.

27. Classification of areas. (1) Controlled area: The licensee shall designate an
area as controlled area where there is a likelihood of receiving an effective dose greater than 6
mSv in a year or an equivalent dose greater than three tenths of any relevant dose limit specified
in Annex III and in which specific protective measures or safety provisions are or could be
required for:

(a) controlling normal exposures or preventing the spread of contamination during

normal working conditions; and
(b) preventing or limiting the extent of potential exposures.

(2) The licensee shall:

(a) determine the boundaries of any controlled area on the basis of the magnitude and
likelihood of expected exposure and the nature and extent of the required
protection and safety provisions;
(b) delineate controlled areas by physical means or, where this is not reasonably
practicable, by some other suitable means;
(c) where a source is brought into operation or energized only intermittently or is
moved from place to place, delineate an appropriate controlled area by means that
are appropriate under the prevailing circumstances and specify exposure times;
(d) display internationally recognized warning symbols and appropriate instructions
at access points and other appropriate locations within controlled areas;
(e) establish occupational protection and safety measures, including local rules and
procedures that are appropriate for controlled areas;
(f) restrict access to controlled areas by means of administrative procedures, such as
the use of work permits, and by physical barriers, which could include locks or
interlocks; the degree of restriction being commensurate with the magnitude and
likelihood of the expected exposures; and
(g) provide at entrances and exits of controlled areas appropriate means for change of
clothing, contamination monitoring and personal decontamination.

(3) Supervised area: The licensee shall designate an area as a supervised area not
already designated as a controlled area but where there is a likelihood of receiving an effective
dose greater than 1 mSv in a year or an equivalent dose greater than one tenth of any relevant
dose limit specified in Annex III and occupational exposure conditions need to be kept under
review even though specific protection measures and safety provisions are not normally needed.

(4) The licensee shall delineate and identify the supervised areas by appropriate
means, taking into account the nature and extent of radiation hazards in those areas.

(5) The licensee shall periodically review conditions to determine the possible need
to revise the protection measures or safety provisions, including the boundaries of controlled and
supervised areas.

28. Rules, procedures and supervision. (1) The licensee shall:

(a) establish in writing such rules and procedures as are necessary to ensure adequate
levels of protection and safety for workers and other individuals;
(b) include in these rules and procedures the values of any relevant reference level or
investigation level and the procedure to be followed in the event that any such
value is exceeded;
(c) ensure that any work involving occupational exposure be adequately supervised
and take all reasonable steps to ensure that the rules, procedures, protective
measures and safety provisions are observed.
 (2) The licensee shall:

(a) provide to all workers adequate information on the health risks due to their
occupational exposure, whether normal exposure or potential exposure, adequate
instruction and training on protection and safety, including information on general
and local rules and procedures and on available protection and safety provisions,
as well as adequate information on the significance for protection and safety of
their actions;
(b) provide to female workers who are liable to enter controlled areas or supervised
areas appropriate information on:

(i) the risk to the embryo or foetus due to exposure of a pregnant woman;
(ii) the importance for a female worker of notifying as soon as she suspects
that she is pregnant; and
(iii) the risk to an infant ingesting radioactive substances by breast feeding;

(c) provide to those workers who could be affected by an emergency plan appropriate
information, instruction and training; and
(d) keep records of the training provided to individual workers.

29. Personal protective equipment. The licensee shall:

(a) minimize the need for relying on administrative controls and personal protective
equipment for protection and safety during normal operations by providing
appropriate protective well engineered controls and satisfactory working
conditions;
(b) if necessary, ensure that workers are provided with suitable and adequate personal
protective equipment, including as appropriate:

(i) protective clothing;

(ii) protective respiratory equipment with information on its protection
characteristics and instruction on its proper use; and
(iii) protective aprons, gloves and organ shields;

(c) arrange for regular testing and maintenance to be carried out on all personal
protective equipment, including, as required, special equipment for use in the
event of accidents and interventions; and
(d) take into account the following factors when assigning personal protective
equipment for a given task:

(i) medical fitness to sustain possible extra physical effort while using the
protective equipment; and
(ii) additional work time or inconvenience or additional non-radiological risks
associated with the use of the protective equipment.

30. Individual monitoring and exposure assessment. (1) The licensee shall
arrange for the assessment of the occupational exposure of workers and shall ensure that
adequate arrangements are made with appropriate dosimetry services under an adequate quality
assurance programme.
 (2) For any worker who works in controlled area individual monitoring shall be
undertaken.

(3) The nature, frequency and precision of individual monitoring shall be determined
with consideration of the magnitude and possible fluctuations of exposure levels and the
likelihood and magnitude of potential exposures.

(4) The licensee shall ensure that workers who may be exposed to radioactive
contamination, including workers who use protective respiratory equipment, are identified and
shall arrange for appropriate monitoring to the extent necessary to demonstrate the effectiveness
of the protection provided and to assess the intake of radioactive substances or the committed
doses, as appropriate.

31. Monitoring of workplace. (1) The licensee shall establish, maintain and
keep under review a programme for the monitoring of the workplace commensurate with the
nature of and the risks associated with the source.

(2) The nature and frequency of monitoring of workplaces shall:

(a) be sufficient to enable:

(i) evaluation of the radiological conditions in all workplaces;

(ii) exposure assessment in controlled areas and supervised areas; and
(iii) review of the designation of controlled and supervised areas;

(b) depend on the levels of ambient equivalent dose and airborne and surface activity
concentration, including their expected fluctuations and the likelihood and
magnitude of potential exposures.

(3) The programmes for monitoring of the workplace shall specify:

(a) the quantities to be measured;

(b) where and when the measurements are to be made and at what frequency;
(c) the most appropriate measurement methods and procedures; and
(d) reference levels and the actions to be taken if these are exceeded.

(4) The licensee shall keep appropriate records of the findings of the workplace
monitoring programme, which shall be made available to workers.

32. Records of worker exposure. (1) The licensee shall maintain records of
exposure for each worker for whom assessment of occupational exposure is required under
regulation no. 30. Such worker exposure records shall include information on:

(a) the general nature of the work resulting in exposure, the doses and intakes and the
data upon which the dose assessments are based;
(b) the periods of employment with different licensees, if any, and the corresponding
doses and intakes in each period of employment; and
(c) the doses or intakes due to emergency interventions or accidents, which shall be
distinguished from doses and intakes received during work in normal condition.

(2) The licensee shall:

 (a) provide for access by workers to information in their own exposure records and
workplace monitoring where appropriate; and
(b) upon request of the Authority or other relevant persons or organizations with a
demonstrated need for such records, including relevant employers and supervisors
of the health surveillance programme, provide access to worker exposure records
with due care and attention to the maintenance of appropriate confidentiality.

(3) Exposure records of each worker shall be retained by the licensee and supplied to
the Authority if desired. These records shall be preserved at least until the worker attains or
would have attained the age of seventy five (75) years, and for not less than thirty (30) years
after the termination of the work involving occupational exposure.

33. Health surveillance. The licensee, in accordance with the requirements

established by the Authority (Annex VI), shall make arrangements for appropriate health
surveillance based on general principles of occupational health and designed to assess the initial
and continuous fitness of regular workers working in the controlled area for their intended tasks.

34. Special circumstances. (1) If a practice which is justified and for which
radiation safety is optimized presents special circumstances which require a temporary change in
some dose limitation requirements of these regulations, the licensee shall not make any such
temporary change without approval of the Authority.

(2) The application submitted by the licensee to obtain this approval shall include
evidence to demonstrate that:

(a) all reasonable efforts have been made to reduce exposures and optimize radiation
safety provisions in accordance with the requirements of these regulations; and
(b) workers have been consulted on the need for and the conditions of the temporary
change in dose limitation requirements.

MEDICAL EXPOSURE PROTECTION

35. General responsibilities. (1) The licensee shall ensure that:

(a) no patient is administered a diagnostic or therapeutic medical exposure unless the

exposure is prescribed by a medical professional;
(b) medical professionals are assigned the primary task and obligation of ensuring
overall patient protection and safety in the prescription of, and during the delivery
of, medical exposure;
(c) medical and health professionals are available as needed and have appropriate
training adequately to discharge assigned tasks in the conduct of the diagnostic or
therapeutic procedures that the medical professional prescribes;
(d) for therapeutic uses of radiation (including teletherapy and brachytherapy), the
calibration, dosimetry and quality assurance requirements of these regulations are
conducted by or under the supervision of a qualified expert in radiotherapy
physics; and
(e) the exposure of individuals incurred knowingly while voluntarily helping (other
than in their occupation) in the care, support or comfort of patients are constrained
as specified in Annex III.
 (2) The licensee shall ensure fulfillment of quality assurance requirements as laid
down under these regulations.

36. Justification of medical exposures. (1) Medical professionals shall consider

the justification of medical exposures that they prescribe by weighing the diagnostic or
therapeutic benefits they produce against the radiation detriment they might cause, taking into
account the benefits and risks of available alternative techniques that do not involve medical
exposure.

(2) Any radiological examination for occupational, legal or health insurance purposes
undertaken without reference to clinical indications shall not be performed unless the specific
type of examination is justified by medical professional.

(3) Mass screening of population groups involving medical exposure is deemed to be

not justified unless the expected advantages for the individuals examined or for the population as
a whole are sufficient to compensate for the economic and social costs, including the radiation
detriment.

37. Optimization of protection for medical exposures. In addition to satisfying

the general requirements for optimisation of radiation safety, the licensee shall satisfy the
prescriptive design and operational requirements specified in Annex IV.

38. Dose Constraints. The licensee shall constrain any dose to individuals
incurred while voluntarily helping (other than in their occupation) in the care, support or comfort
of patients undergoing medical exposure, and to visitors to patients who have received
therapeutic amounts of radionuclides or who are being treated with brachytherapy sources, to a
level not exceeding that specified in Annex III.

39. Calibration and clinical dosimetry for medical exposures. (1) The licensee
shall ensure that:

(a) the calibration of sources used for medical exposure is traceable to a Standards
Dosimetry Laboratory;
(b) each type of radiotherapy equipment is calibrated in terms of the relevant
dosimetric quantities and irradiation conditions;
(c) unsealed sources for nuclear medicine procedures are calibrated in terms of
activity of the radio-pharmaceutical to be administered; and
(d) calibrations of equipment are carried out at the time of commissioning of a
source, after any maintenance procedure that may effect the calibration, as well as
at regular intervals approved by the Authority.

(2) The licensee shall ensure that the representative values of clinical dosimetry
parameters are determined and documented.

40. Quality assurance for medical exposures. Quality assurance programmes for
medical exposures shall include:

(a) measurements of the physical parameters of the radiation generators including

therapeutic and diagnostic equipment at the time of commissioning and
periodically (which period shall not be more than twelve calendar months)
thereafter;
 (b) verification of the appropriate physical and clinical factors used in patient
diagnosis or treatment;
(c) written records of relevant procedures and results;
(d) verification of the appropriate calibration and conditions of operation of
dosimetry and monitoring equipment; and
(e) as far as possible, regular and independent quality audit reviews of the quality
assurance programme for radiotherapy procedures.

41. Guidance levels for medical exposure. (1) Guidance levels for medical
exposure (Annex V) shall be used by medical professionals in the conduct of diagnostic and
therapeutic procedures involving exposure to radiation as well as in the optimisation of
protection of patients.

(2) The guidance levels shall be applied with flexibility to allow higher exposures if
these are indicated by sound clinical judgements and shall be revised as required by
technological and scientific developments.

42. Maximum activity for patients in therapy on discharge from hospital. In

order to restrict the exposure of any member of the household of a patient who has undergone a
therapeutic procedure with sealed or unsealed radionuclides and of members of the public, such a
patient shall not be discharged from hospital before the activity of radioactive substances in the
body falls below the level specified in Annex V unless otherwise justified and the justification is
documented. Written instructions to the patient concerning contact with other persons and
relevant precautions for radiation protection shall be provided as necessary.

43. Medical surveillance for abnormal situation. (1) The licensee shall ensure
that in case of radiation accident situations, adequate medical facilities and staff are available for
the administration of first aid and for carrying out external decontamination of the affected
persons without any delay.

(2) The adequacy of such facilities shall be regularly reviewed by the licensee.

(3) The licensee shall make necessary arrangements that in case of radiation injuries,
affected persons are immediately transferred to hospitals designated to treat such injuries.

44. Investigation of accidental medical exposures. (1) The licensee shall

promptly investigate:

(a) any therapeutic treatment delivered to either the wrong patient or the wrong
tissue, or using the wrong pharmaceutical, or with a dose or dose fractionation
differing substantially from the values prescribed by the medical professional;
(b) any diagnostic exposure substantially greater than intended or resulting in doses
repeatedly and substantially exceeding the specified guidance levels; and
(c) any repeated equipment failure, accident, error, mishap or other unusual
occurrence with the potential for causing a patient exposure significantly different
from that intended.

(2) The licensee shall, with respect to any investigation required above:

(a) calculate or estimate the doses received and their distribution within the patient;
 (b) indicate the corrective measures required to prevent recurrence of such an
incident;
(c) implement all the corrective measures that are under their own responsibility;
(d) notify the Authority, by telephone or facsimile as soon as practicable, but not later
than twenty four (24) hours after discovery, of any incident which has the
potential for, or has resulted in, serious injury or death of a patient, or which
involves more than one patient;
(e) submit to the Authority, within thirty (30) days after discovery of the incident, a
written report which states the cause of the incident and includes the information
on the doses, corrective measures and any other relevant information; and
(f) Inform the patient and his/her doctor in confidence about the incident.

45. Records. The licensee shall keep and make available, as appropriate, records
of equipment calibration, clinical dosimetry and quality assurance, as well as any other necessary
information to allow retrospective assessments of the doses received by patients.

PUBLIC EXPOSURE PROTECTION

46. General responsibilities. (1) The licensee shall apply the requirements of
these regulations to any public exposure delivered by a practice or source for which they are
responsible, unless the exposure is excluded from these regulations or the practice or source
delivering the exposure is exempted from the requirements of these regulations.

(2) The licensee shall be responsible, with respect to the sources under their
responsibility, for the establishment, implementation and maintenance of:

(a) radiation safety policies, procedures and organizational arrangements for control
of public exposure;
(b) measures for ensuring:

(i) the optimization of the protection, subject to constraints as may be

appropriate, of members of the public whose exposure is attributable to
such sources; and
(ii) the limitation of the normal exposure of the relevant critical group, which
is attributable to such sources, in order that the total exposure is not higher
than the dose limits for members of the public as specified in Annex III.

(c) measures for ensuring the safety of such sources, in order that the likelihood of
public exposures is controlled in accordance with the requirements of these
regulations;
(d) suitable and adequate facilities, equipment and services for the protection of the
public, the nature and extent of which are commensurate with the magnitude and
likelihood of the exposure;
(e) appropriate radiation safety training, and periodic retraining, to the personnel
having functions such as that of RPO(s) relevant to the protection of the public;
(f) appropriate monitoring equipment and surveillance programmes to assess public
exposure; and
(g) adequate records of the surveillance and monitoring.

47. Control of visitors. The licensee shall:

 (a) ensure that visitors are accompanied in any controlled area by a person
knowledgeable about the radiation safety measures for that area;
(b) provide adequate information and instruction to visitors before they enter a
controlled area so as to ensure appropriate protection of the visitors and of other
individuals who could be affected by their actions; and
(c) ensure that adequate control over entry of visitors to a supervised area are
maintained and that cautionary/ warning signs be posted in such areas.

48. Monitoring of public exposure. The licensee shall, as appropriate:

(a) establish and carry out a monitoring programme, of magnitude and complexity
commensurate with the type of and risks associated with the sources under their
responsibilities, which is sufficient to ensure that the requirements of these
regulations are satisfied and to assess the exposure of members of the public from
sources of external irradiation and/or discharges of radioactive substances in to
the environment, as appropriate;
(b) keep appropriate records of the results of the monitoring programmes; and
(c) report a summary of the monitoring results to the Authority on a yearly basis or
such shorter intervals as approved by the Authority and promptly inform the
Authority of any abnormal results which lead or could lead to an increase of
public exposure.
49. Consumer products. (1) Consumer products capable of causing exposure to
radiation shall not be supplied to members of the public unless:

(a) such exposure is excluded from these regulations under regulation no. 5; or
(b) such products meet the exemption requirements specified in regulation no. 7 or
have otherwise been exempted by the Authority; or
(c) such products are authorized by the Authority for use by members of the public.

(2) Persons who import consumer products for sale and distribution as exempt
products shall ensure that:
(a) legible labels are visibly and firmly affixed to each consumer product and its
package, stating, in urdu language, that:

(i) the product contains radioactive material; and

(ii) the sale of the product to the public has been authorised by the Authority;
(b) basic information and instructions on the precautions of use and disposal of the
product, written in urdu language, are made available with the product.
50. Repeal. Regulation nos. 2, 22, 23, 26 to 32, 34 to 38, 43, 45 to 57 and 65 to 69
and Schedules II to XVI of Pakistan Nuclear Safety and Radiation Protection (PNSRP)
Regulations, 1990 are hereby repealed.
 ANNEX I

EXEMPT CONCENTRATIONS AND QUANTITIES OF

RADIONUCLIDES
Table 1
EXEMPTION LEVELS: EXEMPT ACTIVITY CONCENTRATIONS AND
EXEMPT ACTIVITIES OF RADIONUCLIDES (ROUNDED)

Activity Activity
Nuclide Concentration Activity Nuclide Concentration Activity
(Bq/g) (Bq) (Bq/g) (Bq)
H-3 1 x 106 1 x 109 Ni-63 1 x 105 1 x 108
Be-7 1 x 103 1 x 107 Ni-65 1 x 101 1 x 106
C-14 1 x 104 1 x 107 Cu-64 1 x 102 1 x 106
O-15 1 x 102 1 x 109 Zn-65 1 x 101 1 x 106
F-18 1 x 101 1 x 106 Zn-69 1 x 104 1 x 106
Na-22 1 x 101 1 x 106 Zn-69m 1 x 102 1 x 106
Na-24 1 x 101 1 x 105 Ga-72 1 x 101 1 x 105
Si-31 1 x 103 1 x 106 Ge-71 1 x 104 1 x 108
P-32 1 x 103 1 x 105 As-73 1 x 103 1 x 107
P-33 1 x 105 1 x 108 As-74 1 x 101 1 x 106
S-35 1 x 105 1 x 108 As-76 1 x 102 1 x 105
Cl-36 1 x 104 1 x 106 As-77 1 x 103 1 x 106
Cl-38 1 x 101 1 x 105 Se-75 1 x 102 1 x 106
Ar-37 1 x 106 1 x 108 Br-82 1 x 101 1 x 106
Ar-41 1 x 102 1 x 109 Kr-74 1 x 102 1 x 109
K-40 1 x 102 1 x 106 Kr-76 1 x 102 1 x 109
K-42 1 x 102 1 x 106 Kr-77 1 x 102 1 x 109
K-43 1 x 101 1 x 106 Kr-79 1 x 103 1 x 105
Ca-45 1 x 104 1 x 107 Kr-81 1 x 104 1 x 107
Ca-47 1 x 101 1 x 106 Kr-83m 1 x 105 1 x 1012
Sc-46 1 x 101 1 x 106 Kr-85 1 x 105 1 x 104
Sc-47 1 x 102 1 x 106 Kr-85m 1 x 103 1 x 1010
Sc-48 1 x 101 1 x 105 Kr-87 1 x 102 1 x 109
V-48 1 x 101 1 x 105 Kr-88 1 x 102 1 x 109
Cr-51 1 x 103 1 x 107 Rb-86 1 x 102 1 x 105
Mn-51 1 x 101 1 x 105 Sr-85 1 x 102 1 x 106
Mn-52 1 x 101 1 x 105 Sr-85m 1 x 102 1 x 107
Mn-52m 1 x 101 1 x 105 Sr-87m 1 x 102 1 x 106
Mn-53 1 x 104 1 x 109 Sr-89 1 x 103 1 x 106
Mn-54 1 x 101 1 x 106 Sr-90* 1 x 102 1 x 104
Mn-56 1 x 101 1 x 105 Sr-91 1 x 101 1 x 105
Fe-52 1 x 101 1 x 106 Sr-92 1 x 101 1 x 106
Fe-55 1 x 104 1 x 106 Y-90 1 x 103 1 x 105
Fe-59 1 x 101 1 x 106 Y-91 1 x 103 1 x 106
Co-55 1 x 101 1 x 106 Y-91m 1 x 102 1 x 106
Co-56 1 x 101 1 x 105 Y-92 1 x 102 1 x 105
Co-57 1 x 102 1 x 106 Y-93 1 x 102 1 x 105
Co-58 1 x 101 1 x 106 Zr-93* 1 x 103 1 x 107
Co-58m 1 x 104 1 x 107 Zr-95 1 x 101 1 x 106
Co-60 1 x 101 1 x 105 Zr-97* 1 x 101 1 x 105
Co-60m 1 x 103 1 x 106 Nb-93m 1 x 104 1 x 107
Co-61 1 x 102 1 x 106 Nb-94 1 x 101 1 x 106
Co-62m 1 x 101 1 x 105 Nb-95 1 x 101 1 x 106
Ni-59 1 x 104 1 x 108 Nb-97 1 x 101 1 x 106
Table 1 (cont.)

Activity Activity
Nuclide concentration Activity Nuclide concentration Activity
(Bq/g) (Bq) (Bq/g) (Bq)

Nb-98 1 x 101 1 x 105 I-123 1 x 102 1 x 107

Mo-90 1 x 101 1 x 106 I-125 1 x 103 1 x 106
Mo-93 1 x 103 1 x 108 I-126 1 x 102 1 x 106
Mo-99 1 x 102 1 x 106 I-129 1 x 102 1 x 105
Mo-101 1 x 101 1 x 106 I-130 1 x 101 1 x 106
Tc-96 1 x 101 1 x 106 I-131 1 x 102 1 x 106
Tc-96m 1 x 103 1 x 107 I-132 1 x 101 1 x 105
Tc-97 1 x 103 1 x 108 I-133 1 x 101 1 x 106
Tc-97m 1 x 103 1 x 107 I-134 1 x 101 1 x 105
Tc-99 1 x 104 1 x 107 I-135 1 x 101 1 x 106
Tc-99m 1 x 102 1 x 107 Xe131m 1 x 104 1 x 104
Ru-97 1 x 102 1 x 107 Xe-133 1 x 103 1 x 104
Ru-103 1 x 102 1 x 106 Xe-135 1 x 103 1 x 1010
Ru-105 1 x 101 1 x 106 Cs-129 1 x 102 1 x 105
Ru-106* 1 x 102 1 x 105 Cs-131 1 x 103 1 x 106
Rh-103m 1 x 104 1 x 108 Cs-132 1 x 101 1 x 105
Rh-105 1 x 102 1 x 107 Cs-134m 1 x 103 1 x 105
Pd-103 1 x 103 1 x 108 Cs-134 1 x 101 1 x 104
Pd-109 1 x 103 1 x 106 Cs-135 1 x 104 1 x 107
Ag-105 1 x 102 1 x 106 Cs-136 1 x 101 1 x 105
Ag-110m 1 x 101 1 x 106 Cs-137* 1 x 101 1 x 104
Ag-111 1 x 103 1 x 106 Cs-138 1 x 101 1 x 104
Cd-109 1 x 104 1 x 106 Ba-131 1 x 102 1 x 106
Cd-115 1 x 102 1 x 106 Ba-140* 1 x 101 1 x 105
Cd-115m 1 x 103 1 x 106 La-140 1 x 101 1 x 105
In-111 1 x 102 1 x 106 Ce-139 1 x 102 1 x 106
In-113m 1 x 102 1 x 106 Ce-141 1 x 102 1 x 107
In-114m 1 x 102 1 x 106 Ce-143 1 x 102 1 x 106
In-115m 1 x 102 1 x 106 Ce-144* 1 x 102 1 x 105
Sn-113 1 x 103 1 x 107 Pr-142 1 x 102 1 x 105
Sn-125 1 x 102 1 x 105 Pr-143 1 x 104 1 x 106
Sb-122 1 x 102 1 x 104 Nd-147 1 x 102 1 x 106
Sb-124 1 x 101 1 x 106 Nd-149 1 x 102 1 x 106
Sb-125 1 x 102 1 x 106 Pm-147 1 x 104 1 x 107
Te-123m 1 x 102 1 x 107 Pm-149 1 x 103 1 x 106
Te-125m 1 x 103 1 x 107 Sm-151 1 x 104 1 x 108
Te-127 1 x 103 1 x 106 Sm-153 1 x 102 1 x 106
Te-127m 1 x 103 1 x 107 Eu-152 1 x 101 1 x 106
Te-129 1 x 102 1 x 106 Eu-152m 1 x 102 1 x 106
Te-129m 1 x 103 1 x 106 Eu-154 1 x 101 1 x 106
Te-131 1 x 102 1 x 105 Eu-155 1 x 102 1 x 107
Te-131m 1 x 101 1 x 106 Gd-153 1 x 102 1 x 107
Te-132 1 x 102 1 x 107 Gd-159 1 x 103 1 x 106
Te-133 1 x 101 1 x 105 Tb-160 1 x 101 1 x 106
Te-133m 1 x 101 1 x 105 Dy-165 1 x 103 1 x 106
Te-134 1 x 101 1 x 106 Dy-166 1 x 103 1 x 106
Table 1 (cont.)

Activity Activity
Nuclide concentration Activity Nuclide concentration Activity
(Bq/g) (Bq) (Bq/g) (Bq)

Ho-166 1 x 103 1 x 105 Rn-220* 1 x 104 1 x 107

Er-169 1 x 104 1 x 107 Rn-222* 1 x 101 1 x 108
Er-171 1 x 102 1 x 106 Ra-223* 1 x 102 1 x 105
Tm-170 1 x 103 1 x 106 Ra-224* 1 x 101 1 x 105
Tm-171 1 x 104 1 x 108 Ra-225 1 x 102 1 x 105
Yb-175 1 x 103 1 x 107 Ra-226* 1 x 101 1 x 104
Lu-177 1 x 103 1 x 107 Ra-227 1 x 102 1 x 106
Hf-181 1 x 101 1 x 106 Ra-228* 1 x 101 1 x 105
Ta-182 1 x 101 1 x 104 Ac-228 1 x 101 1 x 106
W-181 1 x 103 1 x 107 Th-226* 1 x 103 1 x 107
W-185 1 x 104 1 x 107 Th-227 1 x 101 1 x 104
W-187 1 x 102 1 x 106 Th-228* 1 x 100 1 x 104
Re-186 1 x 103 1 x 106 Th-229* 1 x 100 1 x 103
Re-188 1 x 102 1 x 105 Th-230 1 x 100 1 x 104
Os-185 1 x 101 1 x 106 Th-231 1 x 103 1 x 107
Os-191 1 x 102 1 x 107 Th-nat 1 x 100 1 x 103
Os-191m 1 x 103 1 x 107 (incl.Th-232)
Os-193 1 x 102 1 x 106 Th-234* 1 x 103 1 x 105
Ir-190 1 x 101 1 x 106 Pa-230 1 x 101 1 x 106
Ir-192 1 x 101 1 x 104 Pa-231 1 x 100 1 x 103
Ir-194 1 x 102 1 x 105 Pa-233 1 x 102 1 x 107
Pt-191 1 x 102 1 x 106 U-230* 1 x 101 1 x 105
Pt-193m 1 x 103 1 x 107 U-231 1 x 102 1 x 107
Pt-197 1 x 103 1 x 106 U-232* 1 x 100 1 x 103
Pt-197m 1 x 102 1 x 106 U-233 1 x 101 1 x 104
Au-198 1 x 102 1 x 106 U-234 1 x 101 1 x 104
Au-199 1 x 102 1 x 106 U-235* 1 x 101 1 x 104
Hg-197 1 x 102 1 x 107 U-236 1 x 101 1 x 104
Hg197m 1 x 102 1 x 106 U-237 1 x 102 1 x 106
Hg-203 1 x 102 1 x 105 U-238* 1 x 101 1 x 104
Tl-200 1 x 101 1 x 106 U-nat 1 x 100 1 x 103
Tl-201 1 x 102 1 x 106 U-239 1 x 102 1 x 106
Tl-202 1 x 102 1 x 106 U-240 1 x 103 1 x 107
Tl-204 1 x 104 1 x 104 U-240* 1 x 101 1 x 106
Pb-203 1 x 102 1 x 106 Np-237* 1 x 100 1 x 103
Pb-210* 1 x 101 1 x 104 Np-239 1 x 102 1 x 107
Pb-212* 1 x 101 1 x 105 Np-240 1 x 101 1 x 106
Bi-206 1 x 101 1 x 105 Pu-234 1 x 102 1 x 107
Bi-207 1 x 101 1 x 106 Pu-235 1 x 102 1 x 107
Bi-210 1 x 103 1 x 106 Pu-236 1 x 101 1 x 104
Bi-212* 1 x 101 1 x 105 Pu-237 1 x 103 1 x 107
Po-203 1 x 101 1 x 106 Pu-238 1 x 100 1 x 104
Po-205 1 x 101 1 x 106 Pu-239 1 x 100 1 x 104
Po-207 1 x 101 1 x 106 Pu-240 1 x 100 1 x 103
Po-210 1 x 101 1 x 104 Pu-241 1 x 102 1 x 105
At-211 1 x 103 1 x 107 Pu-242 1 x 100 1 x 104
Table 1 (cont.)

Activity Activity
Nuclide concentration Activity Nuclide concentration Activity
(Bq/g) (Bq) (Bq/g) (Bq)

Pu-243 1 x 103 1 x 107 Cf-246 1 x 103 1 x 106

Pu-244 1 x 100 1 x 104 Cf-248 1 x 101 1 x 104
Am-241 1 x 100 1 x 104 Cf-249 1 x 100 1 x 103
Am-242 1 x 103 1 x 106 Cf-250 1 x 101 1 x 104
Am-242m* 1 x 100 1 x 104 Cf-251 1 x 100 1 x 103
Am-243* 1 x 100 1 x 103 Cf-252 1 x 101 1 x 104
Cm-242 1 x 102 1 x 105 Cf-253 1 x 102 1 x 105
Cm-243 1 x 100 1 x 104 Cf-254 1 x 100 1 x 103
Cm-244 1 x 101 1 x 104 Es-253 1 x 102 1 x 105
Cm-245 1 x 100 1 x 103 Es-254 1 x 101 1 x 104
Cm-246 1 x 100 1 x 103 Es-254m 1 x 102 1 x 106
Cm-247 1 x 100 1 x 104 Fm-254 1 x 104 1 x 107
Cm-248 1 x 100 1 x 103 Fm-255 1 x 103 1 x 106
Bk-249 1 x 103 1 x 106

* Parent nuclides and their progeny included in secular equilibrium are listed in the
following:

Sr-90 Y-90

Zr-93 Nb-93m

Zr-97 Nb-97

Ru-106 Rh-106

Cs-137 Ba-137m

Ba-140 La-140

Ce-134 La-134

Ce-144 Pr-144

Pb-210 Bi-210, Po-210

Pb-212 Bi-212, Tl-208 (0.36), Po-212 (0.64)

Bi-212 Tl-208 (0.36), Po-212 (0.64)

Rn-220 Po-216

Rn-222 Po-218, Pb-214, Bi-214, Po-214

Ra-223 Rn-219, Po-215, Pb-211, Bi-211, Tl-207

Ra-224 Rn-220, Po-216, Pb-212, Bi-212, Tl-208(0.36), Po-212(0.64)

Ra-226 Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210

Ra-228 Ac-228
Th-226 Ra-222, Rn-218, Po-214

Th-228 Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)

Th-229 Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209

Th-nat Ra-228, Ac-228, Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212,

Tl-208 (0.36), Po-212 (0.64)

Th-234 Pa-234m

U-230 Th-226, Ra-222, Rn-218, Po-214

U-232 Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36),

Po-212 (0.64)

U-235 Th-231

U-238 Th-234, Pa-234m

U-nat Th-234, Pa-234m, U-234, Th-230, Ra-226, Rn-222, Po-218, Pb-214, Bi-214,

Po-214, Pb-210, Bi-210, Po-210

U-240 Np-240m

Np-237 Pa-233

Am-242m Am-242

Am-243 Np-239
 ANNEX II

Table 1

RADIONUCLIDE CONTAMINATION LEVELS IN FOOD ITEMS

Limits of radionuclide
Radionuclide Target Organ concentration level
per Kg of Food
(Bq/Kg)
Strontium-90 Bone surface (infant) 20

Cesium-134 Whole body (adult) 50

Cesium-137 Whole body (adult) 100

Plutonium-239 Bone surface (infant) 2

Exception:

Milk powder shall be treated as being diluted 7 times with water when made ready for use,
therefore, the limits of concentration as given above shall be multiplied by a factor of seven (07).

Formula for addition

This Annex shall be applicable to any of the above single radionuclide present in the food. When
two or more radionuclides are found to be present, the formula applicable in such cases shall be worked
according to the following sum(s):

Actual level of Actual level of

radionuclide A radionuclide B
S =  +  + ---------etc. ≤ 1
Limit for Limit for
radionuclide A radionuclide B
 ANNEX III
DOSE LIMITS FOR EXPOSURES INCURRED FROM PRACTICES

Table 1
ANNUAL DOSE LIMITS FOR RADIATION WORKERS
(Aged 18 years and above)

Organ or Tissue Dose Quantity Dose Limits

(mSv)
Whole body Effective dose 20*

Lens of the eye Equivalent dose 150

Extremities (hands and feet) or Skin (average dose Equivalent dose 500
over 1 cm2 of the most highly irradiated area).

* In special circumstances, an effective dose of up to 50 mSv in a single year provided that the
average dose over five consecutive years does not exceed 20 mSv/year.

Table 2

ANNUAL DOSE LIMITS FOR APPRENTICES/STUDENTS

(16 to 18 years of age)

Organ or Tissue Dose Quantity Dose Limits

(mSv)
Whole body Effective dose 6

Lens of the eye Equivalent dose 50

Extremities (hands and feet) or skin (average dose Equivalent dose 150
over 1 cm2 of the most highly irradiated area).

Table 3

ANNUAL DOSE LIMITS FOR PUBLIC

Organ or Tissue Dose Quantity Dose Limits

(mSv)
Whole body Effective dose 1*

Lens of the eye Equivalent dose 15

Skin Equivalent dose 50

* In special circumstances, an effective dose of up to 5 mSv in a single year provided that the
average dose over five consecutive years does not exceed 1 mSv/year.
 Table 4

DOSE LIMITS FOR COMFORTERS/VISITORS OF PATIENTS

Organ/Tissue Dose Quantity Dose Limits

(mSv)
Whole body (Adult) Effective dose 5

Whole body (Children) Effective dose <1

ANNEX IV
MEDICAL EXPOSURE: DESIGN AND OPERATIONAL
REQUIREMENTS
DESIGN OF NUCLEAR MEDICINE, RADIOLOGY AND RADIOTHERAPY
FACILITIES

(1) The licensee shall ensure, in the design of radiology and radiotherapy facilities,
that the treatment room is designed such that the dose level in the controlled and uncontrolled
areas is within the limits as specified by the Authority. The provisions for safety systems or
devices shall be inherent to the equipment or the room so as to reduce the occurrence of
accidental radiation exposure.

(2) Nuclear medicine: The licensee shall ensure that:

(a) in the design of the facility the following factors have been taken into
consideration:

(i) the classification of areas;

(ii) the type of work to be done; and
(iii) the radionuclides intended to be used and their activities;

(b) a safety assessment is performed in order to determine the special needs

concerning ventilation, plumbing, materials used in walls, floor and benches;
(c) the floors of controlled areas are finished in an impermeable material, which is
washable and resistant to chemical changes;
(d) source storage area is provided;
(e) area for temporary storage of radioactive waste is provided; and
(f) a separate room is provided for patients undergoing radionuclide therapy.

(3) Diagnostic and interventional radiology: The licensee shall ensure that:

(a) due consideration has been given to the:

 (i) classification of areas;
(ii) type of work to be done; and
(iii) X-ray system intended to be used;

(b) the X-ray room is large enough to provide adequate shielding to the staff and to
the persons in adjacent rooms;
(c) the design of the room is such that the X-ray beam cannot be directed at any
unshielded area or towards the doors;
(d) the doors and electric switches are placed at an easily accessible point;
(e) sufficient shielding with lead or equivalent material on walls, ceilings, doors and
floors is incorporated in the design;
(f) the ducts are designed in such a way that significant radiation cannot escape; and
(g) the dark room, film storage and processing room, change room, waiting rooms
and washrooms are located outside the X-ray exposure room.

(4) External beam radiotherapy: The licensee shall ensure that the:

(a) facility includes examination rooms, simulator room, treatment planning room,
mould room, treatment room and waiting areas.
(b) simulator room, treatment planning room and treatment room are designed in
accordance with the design specification of the equipment.
(c) examination room is constructed in close proximity to the treatment room and the
treatment planning room is located near the simulator room.
(d) power, air-conditioning and emergency system requirements are considered at the
design stage.

(5) Low dose-rate brachytherapy: The licensee shall make sure that:

(a) a source storage and preparation room, operating room, treatment planning room
and patient room are incorporated in the design;
(b) these rooms are placed in close proximity so as to reduce distances over which the
patient and source have to be transported; and
(c) the facility design incorporates features to avoid elevator transport of patients
containing radioactive sources.

(6) High dose-rate brachytherapy: The licensee shall make sure that:

(a) an operating room or outpatient surgery room, a radiographic imaging system

room, treatment planning area and treatment room are incorporated in the design.
(b) all these rooms are constructed in close proximity to each other.
 (7) The licensee shall ensure that the common space for all these modalities like
office space for physicians and physicists, laboratories, dark room, patient registration and
admission areas and file rooms are given due consideration while designing the facilities.

DESIGN OF SOURCES AND EQUIPMENTS

(8) The requirements for the safety of sources specified in regulation no. 20 of these
regulations shall apply to sources used in medical exposure where relevant and, in particular,
equipment used in medical exposure shall be so designed that:

(a) failure of equipment or components can be promptly detected so that any

unplanned exposure of patients can be avoided or minimised; and
(b) the risk of delivering unplanned exposure to patients by human error is
minimised.

(9) The licensee, in co-operation with suppliers where relevant or appropriate, shall:
(a) ensure that radiation generators, sources and accessories are designed and
manufactured so as to facilitate the keeping of medical exposures as low as
reasonably achievable consistent with obtaining adequate diagnostic information
or therapeutic results;
(b) ensure that equipment containing sources for medical exposure conforms with
applicable standards;
(c) ensure that performance specifications and operating and maintenance
instructions, including radiation safety aspects, are provided in a major world
language understandable to the users as well as in the local language;
(d) identify and take all reasonable measures to prevent failures and human errors that
could result in unplanned medical exposures, including the establishment of
adequate procedures for calibration, quality assurance and operation of diagnostic
and therapeutic equipment as well as the selection, training and periodic retraining
of suitably qualified personnel;
(e) ensure that any radiation emitting equipment is provided with radiation beam
control mechanisms, including safety interlocks and clear and fail-safe ‘on-off’
indicators;
(f) ensure that devices are provided to limit the exposure to the area being examined
or treated and keep exposure rates outside this area, due to radiation leakage or
scattering, as low as reasonably achievable;
(g) ensure that, when appropriate, monitoring equipment is installed or is available to
give warning of an unusual situation or trend in the use of radiation emitting
equipment for diagnostic or therapeutic applications.

OPERATIONAL ASPECTS

(10) Diagnostic exposure: The licensee shall make sure that:

(a) the medical practitioners who prescribe or conduct radiological diagnostic
examinations:
 (i) ensure that the appropriate equipment is used;
(ii) ensure that the exposure of patients is the minimum necessary to achieve
the required diagnostic objective, taking into account norms of acceptable
image quality established by appropriate professional bodies and relevant
guidance levels for medical exposure;
(iii) take into account relevant information from previous examinations in
order to avoid unnecessary additional examinations;
(iv) avoid radiological examinations causing exposure of the abdomen or
pelvis of women who are pregnant or likely to be pregnant unless there are
strong clinical reasons for such examinations;
(v) plan any diagnostic examination of the abdomen or pelvis of women of
reproductive capacity so as to deliver the minimum dose to any embryo or
foetus that might be present;
(vi) ensure that portable and mobile radiological equipment is used only for
examinations where it is impractical or not medically acceptable to
transfer patients to a stationary radiological installation and only after
proper attention has been given to the radiation protection measures
required in its use; and
(vii) ensure that, whenever feasible, shielding of radiosensitive organs such as
the gonads, lens of the eye, breast and thyroid is provided as appropriate.

(b) the medical practitioner, the technologist or other imaging staff select the
following parameters, as relevant, such that their combination produce the
minimum patient exposure consistent with acceptable image quality and the
clinical purpose of the examination, paying particular attention to this selection
for paediatric radiology and interventional radiology:

(i) the area to be examined, the number and size of views per examination
(e.g. number of films or computed tomography slices) or the time per
examination (e.g. fluoroscopic time);
(ii) the type of image receptor (e.g. high versus low speed screens);
(iii) the use of antiscatter grids;
(iv) proper collimation of the primary X ray beam to minimize the volume of
patient tissue being irradiated and to improve image quality;
(v) appropriate values of operational parameters (e.g. tube generating
potential, current and time or their product);
(vi) appropriate image storage techniques in dynamic imaging (e.g. number of
images per second); and
(vii) adequate image processing factors (e.g. developer temperature and image
reconstruction algorithms).

(11) Nuclear medicine: The licensee shall make sure that:

(a) the medical practitioners who prescribe or conduct diagnostic/therapeutic
applications of radionuclides:
 (i) ensure that the exposure of patients is the minimum required to achieve
the intended diagnostic objective taking into account relevant guidance
levels for medical exposure;
(ii) take into account relevant information from previous examinations in
order to avoid unnecessary additional examinations;
(iii) avoid administration of radionuclides for diagnostic procedures to women
pregnant or likely to be pregnant unless there are strong clinical
indications;
(iv) for mothers in lactation, recommend discontinuation of nursing until the
radiopharmaceutical is no longer secreted in an amount estimated to give
an unacceptable effective dose to the nursling; and
(v) ensure that administration of radionuclides to children for diagnostic
procedures is carried out only if there is a strong clinical indication, and
the activity of the radionuclides administered is reduced according to body
weight, body surface area or other appropriate criteria.

(b) the medical practitioner, the technologist or other imaging staff, as appropriate,
endeavour to achieve the minimum patient exposure consistent with acceptable
image quality by:

(i) appropriate selection of the best available radiopharmaceutical and its

activity, noting the special requirements for children and for patients with
impairment of organ function;
(ii) use of methods for blocking the uptake in organs not under study and for
accelerated excretion when applicable; and
(iii) appropriate image acquisition and processing.

(12) Therapeutic exposure: The licensee shall make sure that the medical practitioners
who prescribe or conduct radiotherapy procedures with radiation sources or with radionuclides or
radiation apparatus/generators:

(a) ensure that the prescribed absorbed dose is delivered to the planning target
volume or organ;
(b) ensure that exposure of normal tissue during radiotherapy is kept as low as
reasonably achievable consistent with delivering the required dose to the planning
target volume, and organ shielding is used when feasible and appropriate;
(c) avoid radiotherapeutic procedures causing exposure of the abdomen or pelvis of
women who are pregnant or likely to be pregnant unless there are strong clinical
indications;
(d) avoid administration of radionuclides for therapeutic procedures to women who
are pregnant or likely to be pregnant or who are nursing, unless there are strong
clinical indications;
(e) plan any therapeutic procedure for pregnant women so as to deliver the minimum
dose to any embryo or foetus; and
(f) inform the patient of possible risks.
 ANNEX V
GUIDANCE LEVELS OF DOSE, DOSE RATE AND ACTIVITY FOR
MEDICAL EXPOSURE

TABLE 1

GUIDANCE LEVELS OF DOSE FOR DIAGNOSTIC RADIOGRAPHY

FOR A TYPICAL ADULT PATIENT

Examination Entrance surface dose

per radiographa
(mGy)

AP 10
Lumbar spine LAT 30
LSJ 40

Abdomen, intravenous urography AP 10

and cholecystography

Pelvis AP 10
Hip joint AP 10
Chest PA 0.4
LAT 1.5
Thoracic spine AP 7

LAT 20
Dental Periapical 7
AP 5
PA 5
Skull LAT 3

Notes: PA: posterior- anterior projection; LAT: lateral projection; LSJ: lumbo -sacral -
joint projection; AP: anterior- posterior projection.
a
In air with backscatter. These values are for conventional film -screen combination in the
relative speed of 200. For high speed film -screen combinations (400- 600), the values should be
reduced by a factor of 2 to 3.
 TABLE 2
DOSE GUIDANCE LEVELS FOR COMPUTED TOMOGRAPHY
FOR A TYPICAL ADULT PATIENT

Multiple scan average dosea

Examination (mGy)

Head 50
Lumbar spine 35
Abdomen 25

a
Derived from measurements on the axis of rotation in water equivalent phantoms, 15 cm in
length and 16 cm (head) and 30 cm (lumbar spine and abdomen) in diameter.

TABLE 3

DOSE GUIDANCE LEVELS FOR MAMMOGRAPHY FOR A

TYPICAL ADULT PATIENT

Average glandular dose per cranio-caudal projectiona

1 mGy (without grid)
3 mGy (with grid)
a
Determined in a 4.5 cm compressed breast consisting of 50% glandular and 50% adipose
tissue, for film -screen systems and dedicated Mo-target Mo-filter mammography units.

TABLE 4

DOSE RATE GUIDANCE LEVELS FOR FLUOROSCOPY

FOR A TYPICAL ADULT PATIENT

Entrance surface dose ratea

Mode of operation (mGy/min)

Normal 25
High levelb 100
a
In air with backscatter.
b
For fluoroscopes that have an optional `high level' operational mode, such as those frequently
used in interventional radiology.
 TABLE 5

GUIDANCE LEVELS OF ACTIVITY FOR PROCEDURES

IN NUCLEAR MEDICINE FOR A TYPICAL ADULT PATIENT

Maximum usual
a
Test Radio- Chemical form activity per testb
nuclide (MBq)
Bone
99
Bone imaging Tcm Phosphonate and 600
Phosphate compounds
99
Bone imaging by single Tcm Phosphonate and 800
photon emission Phosphate compounds
computerized tomography
(SPECT)
99
Bone marrow imaging Tcm Labelled colloid 400

Brain
99
Brain imaging (static) Tcm TcO-4 500
99
Tcm Diethylenetriaminepenta- 500
acetic acid (DTPA),
gluconate and glucoheptonate
99
Brain imaging (SPECT) Tcm TcO-4 800
99
Tcm DTPA, gluconate and 800
Glucoheptonate
99
Tcm Exametazime 500
133
Cerebral blood flow Xe In isotonic sodium 400
chloride solution
99
Tcm Hexamethyl propylene 500
amine oxime (HM-PAO)
111
Cisternography In DTPA 40

Lacrimal
99
Lacrimal drainage Tcm TcO14 4
99
Tcm Labelled colloid 4

Thyroid
99
Thyroid imaging Tcm TcO-4 200
123
I I- 20
131
Thyroid metastases I I- 400
(after ablation)
201
Parathyroid imaging Tl Tl+ , chloride 80

Lung
81
Lung ventilation imaging Krm Gas 6000
99
Tcm DTPA –aerosol 80
133
Lung ventilation study Xe Gas 400
127
Xe Gas 200
81
Lung perfusion imaging Krm Aqueous solution 6000
 Maximum usual
Test Radio- Chemical forma activity per testb
nuclide (MBq)
99
Tcm Human albumin 100
(macroaggregates or
microspheres)
99
Lung perfusion imaging Tcm Human albumin 160
(with venography) (macroaggregates or
microspheres)
133
Lung perfusion studies Xe Isotonic solution 200
127
Xe Isotonic chloride solution 200
99
Lung imaging (SPECT) Tc Macroaggregated albumin 200
(MAA)

Liver and spleen

99
Liver and spleen imaging Tcm Labelled colloid 80
99
Functional biliary system Tcm Iminodiacetates and 150
Imaging equivalent agents
99
Spleen imaging Tcm Labelled denaturated 100
red blood cells
99
Liver imaging (SPECT) Tcm Labelled colloid 200

Cardiovascular
99
First pass blood flow Tcm TcO-4 800
99
Studies Tcm DTPA 800
99
Tcm Macroaggregated globulin 3 400
99
Blood pool imaging Tcm Human albumin complex 40
99
Cardiac and vascular Tcm Human albumin complex 800
imaging/probe studies
99
Myocardial imaging/probe Tcm Labelled normal red blood 800
studies Cells
99
Myocardial imaging Tcm Phosphonate and 600
Phosphate compounds
99
Myocardial imaging Tcm Isonitriles 300
201
(SPECT) Tl Tl+ Chloride 100
99
Tcm Phosphonate and 800
Phosphate compounds
99
Tcm Isonitriles 600

Stomach,
gastrointestinal tract
99
Stomach/salivary gland Tcm TcO-4 40
imaging
99
Meckel's diverticulum Tcm TcO-4 400
Imaging
99
Gastrointestinal bleeding Tcm Labelled colloid 400
99
Tcm Labelled normal red blood 400
Cells
99
Oesophageal transit and Tcm Labelled colloid 40
99
reflux Tcm Non –absorbable compounds 40
99
Gastric emptying Tcm Non –absorbable compounds 12
 Maximum usual
Test Radio- Chemical forma activity per testb
nuclide (MBq)
111
In Non- absorbable compounds 12
113
Inm Non- absorbable compounds 12

Kidney, urinary system

and adrenals
99
Renal imaging Tcm Dimercaptosuccinic acid 160
99
Renal imaging/renography Tcm DTPA, glirconate and 350
Glucoheptonate
99
Tcm Macroaggregated globulin 3 100
123
I O-iodohippurate 20
75
Adernal imaging Se Selenorcholesterol 8

Miscellaneous
67
Tumour or abscess Ga Citrate 300
201
Imaging Tl Chloride 100
99
Tumour imaging Tcm Dimercaptosuccinic acid 400
Neuroectodermal tumour 123I Meta -iodo –benzyl 400
imaging Guanidine
131
I Meta-iodo-benzyl guanidine 20
99
Lymph node imaging Tcm Labelled colloid 80
99
Abscess imaging Tcm Exametazime labelled white 400
Cells
111
In Labelled white cells 20
111
Thrombus imaging In Labelled platelets 20
a
In some countries some of the compounds are considered obsolete.
b
In some countries the typical values are lower than those indicated in the table.

TABLE 6

GUIDANCE LEVEL FOR MAXIMUM ACTIVITY

FOR PATIENTS IN THERAPY ON DISCHARGE FROM HOSPITAL

Radionuclide Activity
(MBq)
Iodine-131 1100a
a
In some countries a level of 400 MBq is used as an example of good practice.
 ANNEX VI

MEDICAL TESTS FOR HEALTH SURVEILLANCE

(1) General tests:

(a) Blood CP (Haemoglobin, ESR, TLC, DLC, RBC & WBC with
Morphology)
(b) Urine (Routine) examination
(c) Chest X-Ray, if needed.

(2) If the working conditions are such that the doses are expected to be higher as in
industrial radiography, in addition to above following tests may be required:

Blood tests Urine examination

(a) Clotting profile (a) Routine examination
(b) Platelet counts (b) Renal Function
(c) HLA Typing Tests
(d) Serum Electrolytes (Sodium,
Potassium etc)
(e) Serum Proteins
(f) Serum Urea/Creatinine

(3) If the nature of work is such that the possibility of exposure through ingestion or
inhalation can be expected to occur like a nuclear medicine department, etc. in addition to blood
& urine examinations, following tests are recommended:

(a) Fecal examaination (Routine & bioassay for radionuclides)

(b) Bioassay of urine for radionuclides
(c) Examinations of other body fluids like sweat, saliva, etc. for radionuclide
detection
(d) Thyroid function tests
(e) Thyroid scan

(4) Psychiatric examination is required in case of reactor operators/supervisors

(5) In addition to above, if any test results indicate some kind of abnormality, the
following tests can be conducted:

(a) bone scanning,

(b) serum electrophoresis,
(c) blood cytogenic analysis & radionuclide detection tests on blood or urine or
(d) any other special test as desired by the treating physician. 

Sd/
JAWAD A. HASHIMI,
Corporate member,
Pakistan Nuclear Regulatory Authority.
1130 THE GAZETTE OF PAKISTAN, EXTRA.. DECEMBER 23, 2010 [PART II]

Annexure-VII

QUALIFICATION & TRAINING CRITERIA FOR RPO/HEALTH PROFESSIONAL/

MEDICAL PROFESSIONAL OF RADIATION FACILITIES AND PRACTICES

≠
Training
Serial
Type of Facility Qualification Period
No.
(months)
1. M.S. in Medical Physics or
2. M.B.,B.S. plus following qualification in order of
preference:
a) F.C.P.S./F.R.C.R.(Radiotherapy) or equivalent
recognized by P.M.D.C. or
Radiotherapy/ Nuclear 03
01. b) Diplomate American Board (Radiotherapy)
Medicine
recognized by P.M.D.C. or
c) D.M.R.T./M.C.P.S.(Radiotherapy) recognized by
P.M.D.C. with 03 years practical experience in
radiotherapy after post graduation
M.Sc. with Physics or Chemistry or *M.B.,B.S. 06
1. M.S. in Medical Physics/Health Physics or
2. M.B., B.S. plus following qualification in order of
preference:
a) F.C.P.S./F.R.C.R. or equivalent recognized by
Radiology (Interventional P.M.D.C. or
Diagnostic, CT, Angio- 03
b) Diplomate American Board (Radiology) recognized
graphy, Fluoroscopy &
by P.M.D.C. or
Mammography)
02. c) D.M.R.D./M.C.P.S. (Radiology) recognized by
P.M.D.C. with 03 years practical experience in
Radiology after post graduation
M.Sc. with Physics or Chemistry or *M.B., B.S. 06
*M.B.,B.S. or Certified Radiographer (Medical) 03
Conventional Diagnostic F. Sc. with Physics or Chemistry or equivalent (For small
Radiology (X-ray) independent conventional diagnostic set-ups operating with 06
one X-ray machine)
Irradiator (Sterilization/
03. M.Sc. with Physics or Chemistry 03
Food processing)
Irradiator B.Sc. with Physics or Chemistry 03
04
(Blood/Research) F. Sc with Physics or Chemistry or equivalent 06
F. Sc. with Physics or Chemistry or equivalent and Level-
05. Industrial Radiography 06
II radiography certification
M.Sc. with Physics or Chemistry 03
06. Nuclear Gauges
B.Sc. with Physics or Chemistry 06
1131 THE GAZETTE OF PAKISTAN, EXTRA.. DECEMBER 23, 2010 [PART II]

M.Sc. with Physics or Chemistry 03

07. Oil Well Logging
B.Sc. with Physics or Chemistry 06

Academic Research and M.Sc. with Physics or Chemistry 03

08.
Development B.Sc. with Physics or Chemistry 06
09. Gas Mantle Manufacturing F. Sc. with Physics or Chemistry or equivalent 03
Importers (involved in
10. installation, testing and F. Sc with Physics or Chemistry or equivalent 03
maintenance)
Scanning Machines
F. Sc with Physics or Chemistry or equivalent 03
(Baggage Scanners)
11. Scanning Machines
(Industrial or Cargo F. Sc with Physics or Chemistry or equivalent 06
Scanners)
Radioimmunoassay (RIA)
12. F. Sc with Physics or Chemistry or equivalent 03
Labs

* Registered Medical Practitioner (RMP)

≠ On the job training in relevant radiation protection requirements

ABDUL MANNAN
Secretary

Pak 904 amended vide SRO 836 (I)/2004 dated 5th October 2004