Chapter 10
Dose Limits for Exposure to
Ionizing Radiation
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Dose Limits 2
• Exposure of the general public, patients,
and radiation workers to ionizing radiation
must be limited in order to minimize the
risk of harmful biologic effects.
• Occupational and non-occupational
effective dose (EfD) limits and equivalent
dose (EqD) limits for tissues and organs
such as the lens of the eye, skin, hands,
and feet have been developed for
radiation safety purposes.
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Dose Limits (Cont.) 3
• An EfD limiting system has been
incorporated into Title 10 of the Code of
Federal Regulations, Part 20, a document
prepared and distributed by the U.S.
Office of the Federal Register. The rules
and regulations of the Nuclear Regulatory
Commission (NRC) and fundamental
radiation protection standards governing
occupational radiation exposure are
included in this document.
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Basis of EfD Limiting System 4
• Concept of radiation exposure and of the
associated risk of radiation-induced malignancy is
the basis of the EfD system
• Resource for revised recommendations
• National Council on Radiation Protection and
Measurements (NCRP) Report No. 116
• International Commission on Radiological Protection
(ICRP) Report No. 60
• Future radiation protection standards are expected
to continue to be based on risk.
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Basis of EfD Limiting System
(Cont.) 5
• Reasons medical imaging professionals
must be familiar with previous, existing,
and new guidelines for radiation safety
• They share the responsibility for patient safety
from radiation exposure.
• They are subject to radiation exposure in the
performance of their duties.
• Radiographers may obtain the required
knowledge by becoming familiar with the
functions of the various advisory groups
and regulatory agencies.
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Radiation Protection
Standards Organizations 6
• There are four major
organizations
responsible for
evaluating the
relationship between
radiation EqD and
induced biologic effects.
These organizations are
also concerned with
formulating risk
estimates of somatic
and genetic effects of
irradiation.
International Commission on
Radiological Protection 7
• International authority on the safe use of
ionizing radiation.
• Composed of a main commission, a
chairman and four standing committees.
• Provides recommendations for
• Occupational dose limits
• Public dose limits
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Objectives of the NCRP 8
United Nations Scientific Committee on the
Effects of Atomic Radiation (UNSCEAR) 9
• Formulates radiation protection guidelines
• evaluates human and environmental ionizing
radiation exposures from a variety of sources,
including
• Radioactive materials
• Radiation-producing machines
• Radiation accidents
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National Academy of Sciences/National
Research Council Committee on the
Biological Effects of Ionizing Radiation 10
(NAS/NRC-BEIR)
• Reviews studies of biologic effects of ionizing
radiation and risk assessment.
• Such groups include
• Early radiation workers
• Atomic bomb victims of Hiroshima and
Nagasaki
• Evacuees from the Chernobyl nuclear
power station disaster
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U.S. Regulatory Agencies 11
After radiation
protection standards
have been
determined,
responsible agencies
must enforce them for
the protection of the
general public,
patients, and
occupationally
exposed personnel.
Radiation Safety Program 12
• Facilities providing imaging services must
have an effective and detailed radiation
safety program to ensure adequate safety
of patients and radiation workers.
• Implementation of an effective program
• Begins with administration of the facility
• Must provide resources necessary for creating
and maintaining program
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Radiation Safety Committee
(RSC) 13
• NRC mandates that an RSC be
established for the facility
• Functions of the RSC
• Provides guidance for the program
• Facilitates ongoing operation of the program
• Selects a qualified person to serve as a
radiation safety officer (RSO)
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RSO 14
• An RSO should
• Oversee the program’s daily operation
• Provide for formal review of the program each year
• RSO is normally a
• Medical physicist
• Health physicist
• Radiologist
• Other individual qualified through adequate training
and experience
• RSO has been designated by a health care
facility and approved by the NRC and the state.
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Responsibilities of the RSO 15
• Specifically responsible for developing an
appropriate radiation safety program for
the facility that follows internationally
accepted guidelines for radiation
protection
• Must ensure that the facility’s operational
radiation practices are such that all
people, especially those who are or could
be pregnant, are adequately protected
from unnecessary exposure
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Responsibilities of the RSO
(Cont.) 16
• To fulfill their responsibility, management
of the facility must grant the RSO the
authority necessary to implement and
enforce the policies of the radiation safety
program.
• RSO must also
• Review and maintain radiation-monitoring
records for all personnel
• Be available to provide counseling for
individuals
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Required Training and Experience
for an RSO 17
• Necessary training and experience for an RSO
are described in sections 10 CFR 35.50 and 10
CFR 35.900 of the Code of Federal Regulations.
• There are three training pathways for an RSO.
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18
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Authority of the RSO 19
• 10 CFR 35.24 requires that the licensee
provide the RSO
• Sufficient authority
• Organizational freedom
• Management prerogative to perform certain
duties
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20
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Authority of the RSO (Cont.) 21
• Licensee must establish, in writing, the
authority, duties, and responsibilities of the
RSO.
• Responsible for day-to-day supervision of the
facility’s radiation safety program
• Must have independent authority to stop
operations that are considered unsafe
• Must be given adequate time and resources
and have a sufficient commitment from
management to ensure that radioactive
materials are used in a safe manner
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Authority of the RSO (Cont.) 22
• NRC requires the name of the RSO on the facility’s
radioactive materials license to ensure that license
management has always identified a responsible,
qualified person who can directly interact with the
NRC during inspections and also concerning any
inquiries about the facility’s safety program.
• Usually the RSO is a full-time employee of the
licensed facility.
• Training for an RSO is covered in 10 CFR 35
• See Appendix H in textbook for a list of
requirements.
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Radiation Control for Health
and Safety Act of 1968 23
• Act passed by U.S. Congress in 1968
• Public Law 90-602
• Purpose of law
• To protect the public from the hazards of
unnecessary radiation exposure resulting from
electronic products and diagnostic `x-ray
equipment
• Act permitted the establishment of the
Center for Devices and Radiological
Health (CDRH)
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Radiation Control for Health
and Safety Act of 1968 (Cont.) 24
• CDRH falls under the jurisdiction of the
Food and Drug Administration (FDA).
• CDRH is responsible for conducting an
ongoing electronic product radiation
control program.
• Law 90-602 does not regulate the
diagnostic x-ray user. It is strictly an
equipment performance standard.
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Code of Standards for
Diagnostic X-ray Equipment 25
• Went into effect on
August 1, 1974
• Applies to complete
systems and major
components
manufactured after
that date
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As Low as Reasonably
Achievable (ALARA) Concept 26
• Principle put forth in 1954 by the NCRP
• Radiation exposure should be kept “as low
as reasonably achievable” with consideration
for economic and societal factors
• Described by NCRP as “the continuation of
good radiation protection programs and
practices which traditionally have been
effective in keeping the average and
individual exposures for monitored workers
well below the limit”
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ALARA Concept (Cont.) 27
• Also known as optimization
• Medical imaging personnel and
radiologists share the responsibility to
keep occupational and non-occupational
dose limits ALARA.
• EfDs and EqDs should be well below
maximal allowable levels.
• Goal can usually be achieved through the
employment of proper safety procedures
performed by qualified personnel.
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Model for the ALARA Concept
28
• An extremely
conservative model with
respect to the
relationship between
ionizing radiation and
potential risk
• Relationship is assumed
to be completely linear
and without any Figure 10-2. Dose–response curve. Hypothetical
threshold linear (straight-line) nonthreshold curve for
radiation dose–response relationship. The straight-
• In the interest of safety, line curve passing through the origin in this graph
indicates both that the response to radiation (in
risk of injury should be terms of biologic effects) is directly proportional to
overestimated rather the dose of radiation and that no known level of
than underestimated radiation dose exists below which absolutely no
chance of sustaining biologic damage is evident.
FDA White Paper 29
• FDA supports the premise that “each patient should
get the right imaging examination, at the right time,
with the right radiation dose.”
• FDA announced “the launch of a cooperative
Initiative to Reduce Unnecessary Exposure from
Medical Imaging.”
• Working in conjunction with their partners, the FDA
intends to take specific action.
• By coordinating these efforts, the FDA will be able to
“optimize patient exposure to radiation from certain
types of medical examinations, and thereby reduce
risks while maximizing the benefits of these studies.”
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Consumer–Patient Radiation
Health and Safety Act of 1981 30
• Title IX of Public Law 97-35 (see Appendix I in textbook)
• Provides federal legislation requiring the establishment
of minimal standards for the accreditation of education
programs for people who perform radiologic procedures
and certification of such people
• Purpose of federal act is to ensure that standard
medical and dental radiologic procedures adhere to
rigorous safety precautions and standards.
• Individual states are encouraged to enact similar
statutes and administer certification and accreditation
programs based on the standards therein.
• Because no legal penalty exists for noncompliance,
many states, unfortunately, have not responded with
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Categories of Radiation-
Induced Responses 31
• Many categories encompass the
radiation-induced responses of serious
concern in radiation protection programs.
• Tissue responses
• Stochastic (probabilistic) effects
Tissue Reactions 32
• Biologic somatic effects of ionizing radiation that can
be directly related to the dose received
• Exhibit a threshold dose below which the response
does not normally occur and above which the
severity of the biologic damage increases as the
dose increases
• These effects typically occur only after large doses of
radiation. However, they could also result from long-
term individual low doses of radiation sustained over
several years.
• Effects can be either early or late tissue reactions.
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Early and Late Tissue Reactions 33
Stochastic Effects 34
• Non-threshold, randomly occurring biologic somatic
changes
• Their chances of occurrence increase with each
radiation exposure.
• Examples
• Cancer
• Genetic alterations
• May be demonstrated with the use of both the linear and the
linear-quadratic dose–response curves
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Current Radiation
Protection Philosophy 35
• Both genetic and somatic responses to
ionizing radiation were considered in
developing the present EfD limiting
recommendations.
• Current philosophy is based on the
assumption that a linear non-threshold
relationship exists between radiation dose
and biologic response.
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EfD Limiting System 36
• Method for controlling risk of biologic
damage to radiation workers and the
general public
• Concerns the upper boundary dose of
ionizing radiation that results in a
negligible risk of bodily injury or
hereditary damage
• Limits may be expressed for whole-body
exposure, partial-body exposure, and
exposure of individual organs.
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EfD Limiting System (Cont.) 37
• The sum of external and internal whole-body
exposure is considered for limits.
• Upper limits are designed to minimize the risk to
humans in terms of early and late tissue reactions
and stochastic effects, and they do not include
natural background and medical radiation.
• Upper boundary radiation exposure limits for
occupationally exposed persons are associated with
risks that are similar to those encountered by
employees in other industries such as manufacturing,
trade, or government, which are generally considered
to be reasonably safe.
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EfD Limiting System (Cont.) 38
Revised Concepts of
Radiation Exposure and Risk 39
• Responsible for recent changes in NCRP
recommendations for limits on exposure to
ionizing radiation
• Many conflicting views exist on assessing the
risk of cancer induction from low-level
radiation exposure.
• Adoption of the EfD limiting system is a direct
consequence of this conservatism.
• Benefit obtained from any diagnostic imaging
procedure must always be weighed against
the risk that is taken.
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Occupational Risk 40
• May be equated with occupational risk in
other industries that are generally
considered reasonably safe.
• That risk is generally estimated to be a
2.5% chance of fatal accident over an
entire career.
• The lifetime fatal risk in hazardous
occupations such as logging and deep
sea fishing is many times greater.
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Vulnerability of the Embryo–
Fetus to Radiation Exposure 41
• Embryo–fetus in utero is particularly sensitive
to radiation exposure.
• Epidemiologic studies of atomic bomb survivors
exposed in utero provided conclusive evidence
of a dose-dependent increase in the incidence
of severe intellectual disability for fetal doses
greater than approximately 0.4 Sv.
• Greatest risk for radiation-induced intellectual
disability occurred when the embryo–fetus was
exposed 8 to15 weeks after conception.
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Basis for the EfD Limiting
System 42
• Concept underlying radiation protection
• Any organ in the human body is vulnerable to
damage from exposure to ionizing radiation.
• Some organs are more sensitive to radiation than
others.
• Every organ is at some risk because of the assumed
random nature of somatic or hereditary radiation-
induced effects.
• EfD limiting system includes, for the determination
of EqD for tissues and organs, all radiation-
vulnerable human organs that can contribute to
potential risk, rather than only those human organs
considered critical.
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Tissue Weighting Factor (WT) 43
• EfD limiting system is an attempt to equate the
various risks of cancer and hereditary effects to the
tissues or organs that were exposed to radiation.
• Because various tissues and organs do not have the
same degree of sensitivity to these effects, the
system employed must compensate for the
differences in risk from one organ to another.
Therefore, a tissue weighting factor (WT) is used.
• WT “indicates the ratio of the risk of stochastic
effects attributable to irradiation of a given organ or
tissue (T) to the total risk when the whole body is
uniformly irradiated.”
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WT (Cont.) 44
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Current NCRP Recommendations 45
• Published reports reflect the current
position and recommendations of the
NCRP on radiation protection standards.
• Annual occupational EfD limit
• An annual occupational EfD limit of 50 mSv
(not including medical and natural background
exposure) has been established for the whole
body, with an added recommendation that the
lifetime EfD in mSv should not exceed 10
times the occupationally exposed person’s age
in years.
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Current NCRP Recommendations 46
(Cont.)
• Cumulative EfD (CumEfD) limit
• A radiation worker’s lifetime EfD must be
limited to his or her age in years times 10
mSv.
• EfD limits do not include radiation exposure
from natural background radiation or medical
procedures.
• EfD limits include the possibility of both
internal and external exposure.
• Medical imaging personnel hardly ever receive
EqDs that are close to the annual EfD limit.
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Current NCRP Recommendations 47
(Cont.)
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Current NCRP Recommendations 48
(Cont.)
• ICRP for downward revision of the annual EfD limit
• In 1991 ICRP recommended the reduction of the annual EfD
limit for occupationally exposed people from 50 to 20 mSv.
• NCRP is still considering the possibility of reducing exposure
standards.
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49
Current NCRP Recommendations
(Cont.)
• Limits for nonoccupationally exposed
individuals
• Limit has been set for individual members of
the general public not occupationally exposed.
• NCRP-recommended annual EfD limit is 1 mSv
for continuous or frequent exposures from
artificial sources other than medical irradiation
and natural background and a limit of 5 mSv
annually for infrequent exposures.
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50
Current NCRP Recommendations
(Cont.)
• Limits for pregnant female radiation workers
• NCRP recommends a monthly EqD limit not exceeding 0.5
mSv per month to the embryo–fetus and a limit during the
entire pregnancy not to exceed 5.0 mSv after declaration of
the pregnancy.
• The monthly limit is more stringent.
• Occurrence of tissue reactions, such as small head size and
intellectual disability, is expected to be statistically
negligible if the EqD remains at or below the recommended
limit.
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51
Current NCRP Recommendations
(Cont.)
• Limits for education and training purposes
• The limit for any education and training of individuals
under the age of 18 years is an EfD of 1 mSv annually
(the same as the general public)
• Limits for tissues and organs exposed selectively or
together with other organs
• 150 mSv to the crystalline lens of the eye
• 500 mSv for localized areas of the skin, the hands, and
the feet
• Negligible Individual Dose
• To provide a low-exposure cutoff level so that regulatory
agencies may consider a level of effective dose as being
of negligible risk, an annual negligible individual dose
(NID) of 0.01 mSv/year per source or practice has been
set.
Action Limits 52
• Personnel dosimeter readings should be well
below 1/10th of the maximum EfD limits.
• Health care facilities may establish action limits.
• Limits are set at levels far below the actual limits.
• Limits are meant to trigger an investigation that
should uncover the reason for any abnormal
exposure.
• The RSO must be an active participant in an
ongoing program that is designed to prevent
personnel from receiving anywhere near the
maximum allowed exposures.
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Radiation Hormesis 53
• Concept that there exists a beneficial aspect or result
to groups of individuals from continuing exposure to
small amounts of radiation.
• Advantageous genetic mutations caused by radiation
exposure may have occurred, resembling those that
allow lower animals today to demonstrate radiation
hormesis. Therefore, to assume risk from very small
amounts of radiation exposure (two or three times
normal background levels) may be incorrect.
• Until the radiation hormesis theory is proven, the
medical radiation industry will continue to follow the
principle of ALARA for radiation protection purposes.
Occupational and
Nonoccupational Dose Limits 54
• EfD limits for radiation workers and the
population as a whole
• EfD limits have been established as guidelines.
• The annual upper boundary limits are designed to limit
the stochastic (probabilistic) effects of radiation.
• The annual upper boundary limits take into account the
EqD in all radiation-sensitive organs found in the body.
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Occupational and Nonoccupational
Dose Limits (Cont.) 55
• Special limits for selected areas
• Because the WT factors used for calculating
EfD are so small for some organs, an organ
that is associated with a low WT factor may
receive an unreasonably large dose, whereas
the EfD remains within the allowable total
limit.
• To prevent tissue reactions, special limits are
set for the crystalline lens of the eye and
localized areas of the skin, hands, and feet.
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Occupational and Nonoccupational
Dose Limits (Cont.) 56
**IMPORTANT
**
The End 57
• Review questions at the end of the
chapter
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