IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 3
Principles of radiation protection and
the international framework
Regulatory requirements
Objective
To become aware of the ICRP’s conceptual
framework and the International Basic Safety
Standards requirement (BSS) and related
Safety Guides in radiation protection in
medical field.
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Part 3. Principles of Radiation Protection
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Content
 Principles
of Radiation Protection
 International Basic Safety
Standards
 Regulatory Control
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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 3.
Module 3.1. Basic principles of radiation
protection
Do we need radiation protection
in nuclear medicine?
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What can Radiation Do?
Death
Cancer
Skin Burns
Cataract
Infertility
Genetic effects
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What can Radiation Do?
Deterministic effects
death, skin burns, cataract,
infertility
Stochastic effects
cancer, genetic effects
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EFFECT
Stochastic effects
Deterministic effects
cataract
infertility
erythema
epilation
DOSE
500 mSv cataract
150 mSv for sterility (temporary-males)
2500 mSv for ovarian
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Objectives of Radiation
Protection
 PREVENTION
of deterministic
effect
 LIMITING the probability of
stochastic effect
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The Need for Protection
Applies to all Dose Levels
It is generally assumed that even very
small doses of ionizing radiation can
potentially be harmful (linear no
threshold hypothesis)
 Therefore, persons must be protected
from ionizing radiation at all dose levels

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Who should be Protected in
Nuclear Medicine?
Patient
 Members of his/her family
 Worker
 General public

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How should the people be
protected?
 Optimize
protection
 Justify the exposure
 Dose limitations
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This is the system of
radiological protection as
defined by the ICRP
(International Commission on
Radiological Protection)
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What is the ICRP?
A non-governmental
professional organization
established in 1928 by the
International Congress of
Radiology
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What is the ICRP?





A group of recognized leaders in the field of
radiation protection
concerned with the protection of humans from
ionizing radiation
official relationships with WHO, IAEA, ICRU
convenes task groups of experts to address
particular issues
issues reports and recommendations
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Ionizing Radiation
We live with
1-3 mSv/y
Can kill
4000 mSv
Is there a safe point?
If not, how to deal with the problem?
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To protect the people taking into account the
main objectives of radiation protection the
system of protection should be based on:
A. Individual-related system – dose limit
(absolute maximum risk that society can accept),
optimization
B. Source-related system – limitation on source,
source related constraints – basic protection +
environmental + individual protection (by
shielding, protective clothing...)
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A.
B.
Main site of protection
Environment
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The ICRP Recommendations
ICRP publication 103 - 2007
 The recommended system of radiation
protection is based upon 3 principles:




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Benefit of a practice must offset the radiation
detriment (justification)
Exposures and likelihood of exposure should
be kept as low as reasonably achievable,
economic and social factors being taken into
account (optimization)
Dose limits should be set to ensure that no
individual faces an unacceptable risk in normal
circumstances
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ICRP 103
Weighs all existing data to arrive at
quantitative recommendations for risk,
detriment, dose and dose rate weighting
factors
 Considers exposure to humans only
 Considers exposure in three
categories: occupational, medical,
public

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IAEA BSS (2011) - glossary

Occupational Exposure:
“All exposures of workers incurred in
the course of their work, with the
exception of exposures excluded from
the Standards and exposures from
practices or sources exempted by
the Standards.”
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IAEA BSS (2011) - glossary

Medical Exposure:
“Exposure incurred by patients as part of
their own medical or dental diagnosis or
treatment; by persons, other than those
occupationally exposed, knowingly while
voluntarily helping in the support and
comfort of patients; and by volunteers in a
programme of biomedical research
involving their exposure.”
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IAEA BSS (2011) - glossary

Public Exposure:
“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.”
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Justification
No use of ionizing radiation is justified if
there is no benefit
 All applications must be justified
 This implies to even the smallest
exposures that are potentially harmful
and the risk must be offset by a benefit

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Risk/Benefit Analysis
Need to evaluate the benefits of
radiation - an easy task in the case of
nuclear medicine
 Radiation is the diagnostic and
therapeutic agent
 Assessment of the risks requires the
knowledge of the dose received by
persons

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Optimization
When radiation is to be used then the
exposure should be optimized to
minimize any possibility of detriment.
 Optimization is “doing the best you can
under the prevailing conditions”
 Need to be familiar with techniques and
options to optimize the application of
ionizing radiation - this is really the main
objective of the present course

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Optimization (contd..)
Must take into account the resources
available - this includes economic
circumstances
 Often a tricky question - where shall we
stop, how much shielding should we
really use?
 Governed by the optimization principle

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Optimization Principle
As Low As Reasonably Achievable
This means radiation exposure should be
limited as much as possible keeping in mind
the risk-benefit relation of radiation and its
applications. For example, it is unreasonable to
refuse an X-ray after a bone fracture because
statistically this may shorten your life
expectancy by one day. The benefits of the Xray with its diagnostic value by far outweigh the
risk associated with the radiation exposure.
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…very much in line with the
rest of real life

Both justification and optimization are
part of all strategies when handling
potentially harmful substances or
dealing with risks:
there must be a benefit
 the risk should be kept as low as possible


Same for household chemicals, drugs,
traffic, travel, sports, ….
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A comment on the
optimization principle (As Low
As Reasonably Achievable)

Issues which are often subject of
discussion:
 L … what is a low dose?
 R … what is reasonable?
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What is Low?



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It can be very costly to
consider every dose
level explicitly
Discussions are ongoing about dose levels
below ‘regulatory
concern’
A potential starting point
are doses from natural
background which are
inevitable and one can
assume organisms
have adapted to them
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Average annual
doses in mSv from
natural sources in
European countries
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What is Radon (222Rn)?



It is a radioactive
gas that exists
everywhere in the
atmosphere
It is a member of
the 238U series
It is formed by the
decay of 226Ra
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What is Radon (222Rn)?
Half-life 3.82 days
 It is an alpha emitter decaying to 218Po
 218Po is also an alpha emitter (T½ 3
min)
 Other important decay products are
214Po (a, T½ 0.164 msec) and 214Bi (b,
T½ 19.9 min)

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Why is Radon a Problem?
The hazard arises from the inhalation
of its decay products which are not
gaseous
 Most of the decay products become
attached to aerosols in the atmosphere
and are deposited in the conducting
airways and in the lung during
respiration.

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Other important contributions to
natural exposure: Potassium-40
 40K



constitutes 120 parts per million of stable
potassium which is an essential trace
element in every human body
40K has a half-life of 1.28 x 109 years,
decaying by beta emission (Emax 1.3 MeV)
An 80 kg adult male contains about 180 g of
potassium -> 18 mg of 40K
This gives an annual internal effective dose
of 170 µSv
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The cosmic rays
contribution to the
background radiation
varies markedly with
altitude.
Note, that at cruising
altitude in a Boeing 747
the dose rate is
approximately 5 µSv/h
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Example of Radiation Exposure
to Aircrew to Cosmic Radiation
Exposure of New Zealand aircrew
International Routes

1000 hours per year, with 90% of the time at an altitude of
12 km

6.5 mSv annual dose from cosmic radiation
Domestic Routes

1000 hours per year, with 70% of the time at an altitude of
11 km

3.5 mSv annual dose from cosmic radiation
Adapted from L Collins 2000
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Average Background Doses
UNSCEAR 2008 Report
WORLDWIDE AVERAGE DOSES
Source
Effective dose
Typical range
(mSv per year)
(mSv per year)
External exposure


Cosmic rays
Terrestrial gamma rays
0.4
0.5
0.3-1.0
0.3-0.6
1.2
0.3
0.2-10
0.2-0.8
2.4
1–10
Internal exposure


Inhalation
Ingestion
Total
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What is ‘Reasonable’?

Depends on ‘prevailing conditions’
including
economic
 cultural


Should be based on a risk/benefit
analysis of the practice
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Dose Limitation
No dose limitation for medical exposure
of the patient - it is always assumed that
the benefits for the patient outweigh the
risks
 Limits need to be applied for public and
occupational exposures

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Limits and Constraints


Dose limits are one of the three principles of
protection as introduced by ICRP and BSS.
Fixed dose limits are recommended by ICRP
and often enforced by a national legal process
(Radiation Protection Legislation).
Dose constraints are used in an optimization
process to guide planning. Constraints and
the importance thereof may be subject to
change to achieve the optimum solution to a
problem (Best practice guidelines).
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Optimization and Dose
Limitation
It is NOT the aim to get close to the limit
values - the aim is to get as low as
reasonably achievable
 Is part of risk management
 Keeps the risks of dealing with ionizing
radiation of the same order as other
risks

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IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 3.
Module 3.2. International Basic Safety
Standards
THE INTERNATIONAL ATOMIC ENERGY AGENCY
IAEA was established in 1957 and has the following
functions:
- Safeguards (verification of peaceful uses)
- Technology (fostering the transfer of)
- Safety
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To service
international
conventions
IAEA RADIATION SAFETY
FUNCTIONS
Article III.A.6 of its Statute
To establish
standards of
radiation safety
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To provide for the
application of these
standards
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BASIC SAFETY
STANDARDS
1996
The purpose of the Standards is to
establish basic requirements for
protection against the risk associated
with exposure to ionizing radiation
and for the safety of radiation sources
that may deliver such exposure.
The Standards lay down basic principles
and indicate the different aspects that
should be covered by an effective radiation
protection programme
2011
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The Standards are aimed to serve as a
practical guide for public authorities and
services, employers and workers, specialized
radiation protection bodies, enterprises and
safety and health committees.
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History
First Basic Safety Standards
Revised Basic Safety Standards
Revised and Joint with FAO, ILO, OECD/NEA, WHO
ICRP published revised recommendations
Consultants, Senior experts meetings, ad hoc
working groups, technical committees
6th draft circulated to all member states
7th Draft approved by IAEA Board of Governors
Publication of Interim Version S.S.115I
Formal approval by co-sponsoring organizations
Publication of S.S.115
Interim Revised BSS
Tentative New BSS Publication
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Part 3. Principles of Radiation Protection
1962
1967
1982
1991
1991, 1992, 1993
March 1994
Sept 1994
1994
1994-1996
1996
2011
2012/2013
49
BSS
Jointly sponsored by:
THE FOOD AND AGRICULTURE ORGANIZATION OF THE
UNITED NATIONS (FAO)
THE INTERNATIONAL ATOMIC ENERGY AGENCY (IAEA)
THE INTERNATIONAL LABOUR ORGANIZATION (ILO)
THE NUCLEAR ENERGY AGENCY OF THE OECD (NEA)
THE PAN AMERICAN HEALTH ORGANIZATION (PAHO)
AND
THE WORLD HEALTH ORGANIZATION (WHO)
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The IAEA’s International Standards are based
on

estimates on radiation health effects made by the United
Nations Scientific Committee on the Effects of Atomic
Radiation (UNSCEAR)
and

radiation protection recommendations of
the International Commission on Radiological Protection
(ICRP)
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THE SCIENTIFIC BASIS OF THE STANDARDS
Non-governmental
ICRP
Principles
Recommendations
Governmental
UNSCEAR
IAEA
Effects
Standards
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THE INTERNATIONAL GOVERNMENTAL
CONSENSUS ON THE HEALTH EFFECTS OF
RADIATION
UNSCEAR
The United Nations Scientific Committee on the Effects
of Atomic Radiation
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What is UNSCEAR?
UNSCEAR is a committee of the
UN General Assembly. It was
established in 1955
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How UNSCEAR Works?
MOLECULAR
BIOLOGY
JUDGMENT ON
PLAUSIBILITY
AND ESTIMATES
RADIOEPIDEMIOLOGY
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UNSCEAR
provides estimates of the health
effects of exposure to ionizing
radiation
Such as……
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Life-time risk of dying from radiation
induced cancer ≈ 5% per sievert
UNSCEAR has recently (2008) further assessed the
cancer risk from radiation exposures.
For a population of all ages and both genders, the lifetime risk of dying from radiation induced cancer after an
acute dose of 1000 mSv is about 9% for men and 13%
for women or 11% as a mean. Applying a DDREF of 2,
these data confirm the 10 years old ICRP estimate.
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ICRP
The International Commission of
Radiological Protection (ICRP) makes
recommendations relating to radiation
protection
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Recommendations of the ICRP
Prepared typically by a task group
which includes other experts
 Approved by the full commission
 Published in the journal “Annals of the
ICRP”
 Have no legal status themselves however, are typically the foundation
onto which national legislation is built

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Finally, on the
basis of
UNSCEAR
estimates and
ICRP
recommendations,
the IAEA
establishes
international
standards on
radiation and
nuclear safety
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Hierarchy of IAEA Documents
Safety
Fundamentals
Safety
Standards
Approved by
IAEA Board
of Governors
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Hierarchy of IAEA Documents
Supported by
Safety
Fundamentals
and Standards
Safety
Guides
Safety
Practices
TECDOCs
Technical
Reports
Proceedings
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Layout OF BSS (2011)
INTRODUCTION: Background, objective, scope, Structure
GENERAL-REQUIREMENTS FOR PROTECTION AND SAFETY
Definitions, Interpretation,
Application of the principles of Radiation protection
Responsibilities
Management requirements
Scope
PLANNED EXPOSURE SITUATIONS
Generic requirements
Public exposure
EMERGENCY EXPOSURE SITUATIONS
Occupational exposure
EXISTING EXPOSURE SITUATIONS
Medical exposure
SCHEDULES
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•
•
•
•
•
•
•
•
•
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Definitions
Interpretation
Resolution of conflicts
Entry into force
Application of the principles of
radiation protection
Responsibilities of the government
Responsibilities of the regulatory
body
Responsibilities for protection and
safety
Management requirements
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System of protection and
safety
The standards are based on the following safety principles
Principle 1: Responsibility for safety
Principle 2: Role of government
Principle 3: Leadership and management for safety
Principle 4: Justification of facilities and activities
Principle 5: Optimization of protection
Principle 6: Limitation of risks to individuals
Principle 7: Protection of present and future generations
Principle 8: Prevention of accidents
Principle 9: Emergency preparedness and response
Principle 10: Protective actions to reduce existing or unregulated radiation risks
The three general principles of radiation protection, which concern justification,
optimization of protection and application of dose limits, are expressed in Safety
Principles 4, 5, 6
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QUALIFIED EXPERTS
2.21. The government shall ensure that
requirements are established for:
 (b) the formal recognition of qualified experts;
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


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Specifies who are the responsible
organisations and individuals,
including the Regulatory Authority.
Defines the administrative
requirements, including licensing
and registration.
Uses the dose limitation system
introduced in ICRP report 60..
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OBJECTIVE (1.38)
” These Standards establish
requirements for the protection of
people and the environment from
harmful effects of ionizing radiation
and for the safety of radiation
sources”.
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SCOPE (1.45)
These Standards apply to human activities involving radiation exposure that
are:
(i) Carried out in a State which chooses to adopt these Standards or which
requests any of the Sponsoring Organizations to provide for the
application of these Standards;
(ii) Undertaken by States with the assistance of the Food and Agriculture
Organization of the United Nations, the International Atomic Energy
Agency, the International Labour Organization, the Pan American Health
Organization, the United Nations Environment Programme or the World
Health Organization, in the light of relevant national rules and regulations;
(iii) Carried out by the IAEA or involving the use of materials, services,
equipment, facilities and non-published information made available by the
IAEA or at its request or under its control or
supervision; or
(iv) Carried out under any bilateral or multilateral arrangement whereby the
parties request the IAEA to provide for the application of these Standards
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PRACTICE
Any human activity that introduces additional sources of
exposure or additional exposure pathways, 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
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PRACTICES
Very broad definition
(a) production of sources and use of radiation and radioactive
substances for medical, industrial, veterinary, agricultural,
education, training and research purposes
(b) nuclear fuel cycle
(c) exposure to natural sources specified by Regulatory Authority
as requiring control
(d) anything else specified by Regulatory Authority.
Nuclear medicine is a practice
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PRACTICE
Existing Annual Dose
Pre- existing
annual dose
expected additional
annual dose
attributable to the
source

CONTROL
Introduction, operation and
decommissioning of a practice
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Post-existing
annual
dose
Time
73
Safety measure
Any action that might be taken, condition that might be
applied or procedure that might be followed to fulfil the
basic requirements of Safety Requirements.
Protective action
An action for the purposes of avoiding or reducing
doses that might otherwise be received in an
emergency exposure situation or an existing exposure
situation.
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SITUATIONS REQUIRING
INTERVENTION
•emergency exposure situations requiring protective
actions
•chronic exposure situations requiring remedial
actions
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Remedial Action
The removal of a source or the reduction of its
magnitude (in terms of activity or amount) for the
purposes of preventing or reducing exposures that
might otherwise occur in an existing exposure situation
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INTERVENTION
Existing annual dose

CONTROL
Averted annual dose
by the intervention
Pre-intervention
existing annual dose
Time
Intervention
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Post-intervention
existing annual dose
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77
EXCLUSIONS
Exposures deemed to be unamenable to control
are excluded from the scope of these
Standards,
e.g. 40K in the body,
cosmic radiation at earth’s surface
and unmodified concentrations of
radionuclides in most raw materials.
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EXEMPTION CRITERIA
(a) Radiation risks arising from the practice or a source
within a practice are sufficiently low as not to warrant
regulatory control, with no appreciable likelihood of
situations that could lead to a failure to meet the general
criterion for exemption; or
(b) Regulatory control of the practice or the source would
yield no net benefit, in that no reasonable control
measures would achieve a worthwhile return in terms of
reduction of individual doses or of health risks.
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EXEMPTION
Practice or source may be exempted if
- effective dose < 10mSv in a year
or
- The determination by a regulatory body that a
source or practice need not be subject to some
or all aspects of regulatory control on the basis
that the exposure and the potential exposure
due to the source or practice are too small to
warrant the application of those aspects or that
this is the optimum option for protection
irrespective of the actual level of the doses or
risks.
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GENERIC REQUIREMENTS
3.10. The government or the regulatory body shall determine which
practices or sources within practices are to be exempted from some or
all of the requirements of these Standards, including the requirements
for notification, registration or licensing, using as the basis for this
determination the criteria for exemption specified in Schedule I or any
exemption levels specified by the regulatory body on the basis of these
criteria
• registration
authorization
• licensing
Each application for authorization requires assessment of the nature,
likelihood and magnitude of the expected exposures due to the source
and shall take all necessary measures for protection and safety.
The regulatory body shall approve which sources, including materials and
objects, within notified or authorized practices may be cleared from
further regulatory control.
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GENERIC REQUIREMENTS
FOR PLANNED EXPOSURE
SITUATIONS
Requirement 6: Graded approach
Requirement 7: Notification and authorization
Requirement 8: Exemption and Clearance
Requirement 9: Responsibilities of registrants and
licensees in planned exposures
Requirement 10: Justification of practices
Requirement 11: Optimization of protection and safety
Requirement 12: Dose limits
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Graded Approach
The application of the requirements of these
Standards in planned exposure situations shall be
commensurate with the characteristics of the
practice or the source within a practice, and with
the magnitude and likelihood of the exposures.
3.6. The application of the requirements of these
Standards shall conform to any requirements
specified by the regulatory body, in accordance
with a graded approach; however, not all the
requirements of these Standards are relevant for
every practice or source, nor for all the actions
specified in para. 3.5.
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Requirement 7
Notification
 Authorization (Registration/Licensing)

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Notification


BSS 3.7.” Any person or organization
intending to carry out any of the actions
specified in para. 3.5 shall submit a
notification to the regulatory body of such an
intention”.
“Notification is required for consumer
products only with respect to manufacture,
assembly, maintenance, import, distribution
and, in some cases, disposal.”
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Authorized Legal Persons:
Registrants and Licensees

BSS 3.13. “Registrants and licensees shall bear the
responsibility for setting up and implementing the
technical and organizational measures that are
necessary for protection and safety for the practices
and sources for which they are authorized”.

“Registrants and licensees may designate suitably
qualified persons to carry out tasks relating to these
responsibilities, but they shall retain the prime
responsibility for protection and safety.”
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Authorization: Registration or
Licensing
BSS 3.8. Any person or organization intending to carry out any of the actions specified
in para. 3.5 shall, unless notification alone is sufficient, apply to the regulatory body for
authorization17, which shall take the form of either registration18 or licensing.
3.9. Any person or organization applying for authorization:

(a) Shall submit to the regulatory body the relevant information necessary to
support the application;

(b) Shall refrain from carrying out any of the actions specified in para. 3.5 until the
registration or licence has been granted;

(c) Shall assess the nature, likelihood and magnitude of the expected exposures
due to the source and shall take all necessary measures for protection and safety;

(d) Shall, if there is a possibility for an exposure to be greater than a level as
specified by the regulatory body, have a safety assessment made and submitted to
the regulatory body as part of the application;

(e) Shall, as required by the regulatory body, have an appropriate prospective
assessment made for radiological environmental impacts, commensurate with the
radiation risks associated with the facility or activity.
This applies to nuclear medicine
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Part 3. Principles of Radiation Protection
87
Responsibilities
Main responsibilities:
registrants and licensees
employers
Subsidiary include:
suppliers
workers
health professionals
qualified experts
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Part 3. Principles of Radiation Protection
88
Responsibilities of registrants
and licensees in planned
exposure situations
BSS 3.13. Registrants and licensees shall bear the
responsibility for setting up and implementing the
technical and organizational measures that are
necessary for protection and safety for the practices
and sources for which they are authorized. Registrants
and licensees may designate suitably qualified persons
to carry out tasks relating to these responsibilities, but
they shall retain the prime responsibility for protection
and safety. Registrants and licensees shall document
the names and and responsibilities of persons
designated to ensure compliance with the requirements
of these Standards.
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Part 3. Principles of Radiation Protection
89
Responsibilities
Emergency Situations
 Occupational Exposure
 Medical Exposure
 Public Exposure
 Safety of Sources

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Part 3. Principles of Radiation Protection
90
Requirement 10:
Justification of practices


The government or the regulatory body shall
ensure that only justified practices are
authorized.
3.16. The government or the regulatory body,
as appropriate, shall ensure that provision19
is made for the justification of any type of
practice20 and for review of the justification,
as necessary, and shall ensure that only
justified practices are authorized
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Requirement 11:
Optimization of protection
and safety

The government or regulatory body
shall establish and enforce
requirements for the optimization of
protection and safety, and registrants
and licensees shall ensure that
protection and safety is optimized.
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92
Requirement 12: Dose limits

The government or the regulatory
body shall establish dose limits for
occupational exposure and public
exposure, and registrants and
licensees shall apply these limits.
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Part 3. Principles of Radiation Protection
93
DOSE LIMITATION

3.26 “The government or the regulatory
body shall establish and the regulatory
body shall enforce compliance with the
dose limits specified in Schedule III for
occupational exposures and public
exposures in planned exposure
situations.”
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Part 3. Principles of Radiation Protection
94
RADIATION PROTECTION
REQUIREMENTS FOR MEDICAL
EXPOSURES

Justification of medical exposures

positive net benefit
Optimization of Protection and Safety
 Constraints for medical exposures



of various types
guidance levels for medical exposure.
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Part 3. Principles of Radiation Protection
95
REQUIREMENTS FOR MEDICAL
EXPOSURES
Justification of Medical Exposures

3.154 “Medical exposures shall be
justified by weighing the expected diagnostic
or therapeutic benefits42 that they yield
against the radiation detriment that they might
cause, with account taken of the benefits and
the risks of available alternative techniques
that do not involve medical exposure”.
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96
REQUIREMENTS FOR MEDICAL
EXPOSURES
Optimization of Protection And
Safety
“Registrants and licensees and
radiological medical practitioners shall
ensure that protection and safety is
optimized for each medical exposure.”
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97
Quality assurance for medical
exposures
3.169. Registrants and licensees, in applying the
requirements of these Standards in respect of
management systems, shall establish a comprehensive
programme of quality assurance for medical exposures
with the active participation of medical physicists,
radiological medical practitioners, medical radiation
technologists and, for complex nuclear medicine
facilities, radiopharmacists and radiochemists, and in
conjunction with other health professionals as
appropriate. Principles established by the World Health
Organization, the Pan American Health Organization
and relevant professional bodies shall be taken into
account.
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98
REQUIREMENTS FOR MEDICAL
EXPOSURES
Dose Constraints
3.172. “Registrants and licensees shall
ensure that relevant dose constraints
(para. 3.148(a)(i)) are used in the
optimization of protection and safety in
any procedure in which an individual
acts as a carer or comforter”
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99
MANAGEMENT REQUIREMENTS
 Protection
and safety elements of
the management system
 Safety
culture
 Human
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Factors
Part 3. Principles of Radiation Protection
100
Protection and safety
elements of the management
system
2.47. The principal parties shall demonstrate
commitment to protection and safety at the highest
levels within the organizations for which they are
responsible.
2.49. The principal parties shall ensure that protection
and safety elements of the management system are
commensurate with the complexity of and the radiation
risks associated with the activity.
2.50. The principal parties shall be able to demonstrate
the effective fulfilment of the requirements for the
protection and safety in the management system.
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Management Requirements
SAFETY CULTURE
2.51. The principal parties shall promote and maintain a safety culture by:

(a) Promoting individual and collective commitment to protection and safety at all levels of
the organization;

(b) Ensuring a common understanding of the key aspects of safety culture within the
organization;

(c) Providing the means by which the organization supports individuals and teams in
carrying out their tasks safely and successfully, with account taken of the interactions
between individuals, technology and the organization;

(d) Encouraging the participation of workers and their representatives and other relevant
persons in the development and implementation of policies, rules and procedures dealing
with protection and safety;

(e) Ensuring accountability of the organization and of individuals at all levels for protection
and safety;

(f) Encouraging open communication with regard to protection and safety within the
organization and with relevant parties, as appropriate;

(g) Encouraging a questioning and learning attitude and discouraging complacency with
regard to protection and safety;

(h) Providing means by which the organization continually seeks to develop and strengthen
its safety culture.
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Management Requirements
HUMAN FACTORS
2.52. The principal parties and other parties having
specified responsibilities in relation to protection and
safety, as appropriate, shall take into account human
factors and shall support good performance and good
practices to prevent human and organizational failures
by:


Sound ergonomic principles
Appropriate equipment, safety systems and procedural
requirements
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Safety Assessments
A review of the aspects of design and operation of a
source which are relevant to the protection of persons
or the safety of the source, including the analysis of the
provisions for safety and protection established in the
design and operation of the source and the analysis of
risks associated with normal conditions and accident
situations.
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Requirement 13: Safety
assessment




BSS 3.31.: “Safety assessments shall be conducted at different
stages, including the stages of siting, design, manufacture,
construction, assembly, commissioning, operation,
maintenance and decommissioning (or closure) of facilities or
parts thereof, as appropriate, so as:
(a) To identify the ways in which exposures could be incurred,
account being taken of the effects of external events as well as
of events directly involving the sources and associated
equipment;
(b) To determine the expected magnitudes and likelihood of
exposures in normal operation and, to the extent reasonable
and practicable, make an assessment of potential exposures;
(c) To assess the adequacy of the provisions for protection and
safety.
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Requirement 14: Monitoring for
Verification of Compliance


“Registrants and licensees and employers shall
conduct monitoring to verify compliance with the
requirements for protection and safety”.
BSS 3.37. “The regulatory body shall establish
requirements that monitoring and measurements be
performed to verify compliance with the requirements
for protection and safety. The regulatory body shall
be responsible for the review and approval of
monitoring and measurement programmes of
registrants and licensees”.
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106
Records

BSS 2.40, (d): “Records are maintained
of the results of monitoring and
verification of compliance, as required
by the regulatory body, including
records of the tests and calibrations
carried out in accordance with these
Standards.”
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(Nuclear) Security
The prevention and detection of, and
response to, theft, sabotage,
unauthorized access, illegal transfer or
other malicious acts involving nuclear
material, other radioactive material or
their associated facilities
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Requirement 15: Prevention and
mitigation of accidents
1.
2.
3.
4.
Defense in Depth
Good Engineering Practice
Accident prevention
Emergency preparedness and
response
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109
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110
EXPOSURES
Similar definitions to ICRP



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Occupational Exposure
Public Exposure
Medical Exposure
Part 3. Principles of Radiation Protection
111
Requirement 21: Responsibilities of
employers, registrants and licensees
for the protection of workers
Employers, registrants and licensees shall be responsible for the
protection of workers against occupational exposure.
Employers, registrants and licensees shall ensure that protection
and safety is optimized and that the dose limits for occupational
exposure are not exceeded.
3.74. For workers who are engaged in activities in which they are or could
be subject to occupational exposure in planned exposure situations,
employers, registrants and licensees shall be responsible for:
 (a) Protection of workers against occupational exposure;
 (b) Compliance with other relevant requirements of these Standards.
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Occupational – Schedule III
Dose Limits:




An effective dose of 20mSv per year averaged over five
consecutive years
An effective dose of 50mSv in any single year
An equivalent dose to lens of eye of 20mSv in a year averages
over 5 consecutive years (100mSv in 5 years and of 50mSv in
any single year
An equivalent dose to extremities or skin of 500mSv in a year.
For apprentices (16-18 years of age):



An effective dose of 6mSv in a year
An effective dose to the lens of eye of 20 mSv in a year
An equivalent dose to extremities or skin of 150mSv in a year.
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Occupational
Female workers should notify pregnancy
Notification of an employer of a suspected pregnancy or of breast-feeding cannot be
a requirement on a female worker in these Standards. However, it is important that
all female workers understand the importance of making such notifications so that
their working conditions may be modified accordingly.
Working conditions shall be adapted to
ensure that the embryo and fetus are
afforded the same broad level of
protection as for members of the public.
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Occupational
CLASSIFICATION OF AREAS
Controlled areas - 3.88. Registrants and licensees shall designate
as a controlled area any area31 in which specific measures for
protection and safety are or could be required for:
(a) Controlling exposures or preventing the spread of contamination
in normal operation;
(b) Preventing or limiting the likelihood and magnitude of exposures
in anticipated operational occurrences and accident conditions.
Supervised areas - Registrants and licensees shall designate as a
supervised area any area not already designated as a controlled
area but for which occupational exposure conditions need to be
kept under review, even though specific measures for protection
and safety are not normally needed.
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115
Responsibilities of registrants and
licensees for Medical Exposure
Registrants and licensees shall ensure that no person
incurs a medical exposure unless there has been an
appropriate referral, responsibility has been assumed
for ensuring protection and safety, and the person
subject to exposure has been informed as appropriate
of the expected benefits and risks.
(d) For therapeutic uses of radiation, the requirements
of these Standards for calibration, dosimetry and quality
assurance, including the acceptance and
commissioning of medical radiological equipment, as
specified in paras 3.166, 3.167(c), 3.169 and 3.170, are
fulfilled by or under the supervision of a medical
physicist;;
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Medical Exposure
 Justification
– by weighing diagnostic or therapeutic benefit
against radiation detriment, taking into account
available alternative techniques.
 Optimization
– all other requirements
– plus safety oriented requirements
– minimum patient exposure consistent with
acceptable image quality and clinical purpose
 Guidance levels
– for diagnostic radiological procedures
– for diagnostic nuclear medicine procedures
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Medical Exposure


DOSE CONSTRAINTS DO NOT APPLY TO
PATIENTS, BUT ARE APPLICABLE
for individuals helping in care, support or
comfort of patients, and visitors
Release of patients after as per IAEA Safety
Report 63
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Medical Exposure
DOSE CONSTRAINTS APPLICABLE
 for volunteers subject to exposure as part of a
programme of biomedical research.
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119
Responsibilities for Public
Exposure

3.125. Registrants and licensees in cooperation with
suppliers and with providers of consumerproducts
shall apply the requirements of these Standards and
shall verify and demonstrate compliancewith them, as
specified by the regulatory body, in relation to any
public exposure delivered by a source for which they
have responsibility.
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Public Exposure - Schedule III
DOSE LIMITS
• An effective dose of 1mSv in a year
• In special circumstances, a higher value of effective
dose in a single year could apply, provided that the
average effective dose over five consecutive years
does not exceed 1mSv per year
• An equivalent dose to lens of the eye 15mSv in a
year
• An equivalent dose to skin of 50mSv in a year.
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Public
Radioactive Waste (RADWASS)



minimize
segregate and treat
control discharges.
Source Monitoring, Environmental
Monitoring
Consumer Products
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122
Emergency Exposures
 emergency plans
 intervention level
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123
IAEA Training Material on Radiation Protection in Nuclear Medicine
Part 3.
Module 3.3. Regulatory Control
Responsibilities of the regulatory
bodies
The government or regulatory body shall establish and enforce
requirements for the optimization of protection and safety, and
registrants and licensees shall ensure that protection
and safety is optimized. The prime responsibility for safety must rest
with the person or organization responsible for facilities and activities
that give rise to radiation risks.
Regulatory bodies have responsibility for Enforcement of regulatory
requirements
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125
Responsibilities of the
regulatory body
The regulatory body shall establish or adopt regulations and guides for
protection and safety and shall establish a system to ensure their
implementation.
2.30. The regulatory body shall establish a regulatory system for protection
and safety that includes [8]:
(a) Notification and authorization;
(b) Review and assessment of facilities and activities;
(c) Inspection of facilities and activities;
(d) Enforcement of regulatory requirements;
(e) The regulatory functions relevant to emergency exposure situations and
existing exposure situations;
(f) Provision of information to, and consultation with, parties affected by its
decisions and, as appropriate, the public and other interested parties.
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Part 3. Principles of Radiation Protection
126
National Infrastructure (not exhaustive)
LEGISLATION
REGULATIONS
REGULATORY BODY (INDEPENDENT)
- Notification and Authorization
- Inspection of facilities and activities
- Enforcement of regulatory requirements
GENERAL PROVISIONS / SERVICES
- Environmental Monitoring
- Intervention
- Personal Dosimetry
- Calibration
- Information Exchange
- Education andTraining
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Regulatory Authority
(main characteristics and functions)
ESTABLISHED BY THE GOVERNMENT
Given:
- Powers
- Resources
- Independence (effective)
To:
Nuclear Medicine
- Receive Notifications
- Carry out assessments
- Issue Authorizations/Licenses
- Inspect
- Enforce
Part 3. Principles of Radiation Protection
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Authorization
BSS 3.9: “Any person or organization applying for authorization:
(a) Shall submit to the regulatory body the relevant information
necessary to support the application;
(b) Shall refrain from carrying out any of the actions specified in
para. 3.5 until the registration or licence has been granted;
(c) Shall assess the nature, likelihood and magnitude of the
expected exposures due to the source and shall take all
necessary measures for protection and safety;
(d) Shall, if there is a possibility for an exposure to be greater
than a level as specified by the regulatory body, have a safety
assessment made and submitted to the regulatory body as part
of the application;
(e) Shall, as required by the regulatory body, have an
appropriate prospective assessment made for radiological
environmental impacts, commensurate with the radiation risks
associated with the facility or activity”.
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129
Authorization
The authorization should be renewed periodically.
Periods should be based on safety criteria and
established by the Regulatory Authority.
The Regulatory Authority may consider suspending
or revoking an authorization when the licensees are
in serious breach of the requirements of the BSS or
the national regulations and laws.
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Authorization
The following activities related to Nuclear Medicine
should be Authorized:
• import, distribution, sale or transfer of radioactive
substances
•installation and maintenance of nuclear medicine
equipment
• disposal of radioactive waste
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131
Application for Authorization
Type of Authorization
•
New
•
Amendment to existing authorization
•
Renewal of authorization
Purpose of Application
•
Constructions
•
Import/Purchase
•
Use/Begin operation
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Application for Authorization
General information:
• Name and address of organization
• Name and information about qualified experts
- RPO
- Medical Physicist
• Responsible representative of the legal person
• Proposed date of installation and/or commissioning
of facilities and equipment
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Application for Authorization
SOURCES:
• Radionuclides involved in the work
• Containment of the radionuclides
• Work pattern
• Work locations
• Radioactive waste
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134
Application for Authorization
FACILITIES AND EQUIPMENT
Facility specifications
Location
Layout
Ventilation, plumbing and surfaces
Equipment specifications
Imaging equipment
Activity meter
Safety equipment
Monitoring equipment
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135
Application for Authorization
RADIATION PROTECTION PROGRAMME
Organizational structure
Area classification
Individual and workplace monitoring
Local rules and supervision
Quality assurance
Transportation of radioactive material
Emergency procedures
Radioactive waste
Records
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Application for Authorization
MEDICAL EXPOSURE
• Responsibilities
• Justification
• Optimization
• Calibration
• Clinical dosimetry
• Quality assurance
• Dose constraints
• Investigation of accidental medical exposures
• Guidance levels
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137
Inspections
An inspection to assess the status of compliance with
regulatory requirements and safety of an authorized
operation should be based on direct observation of
work activities, interviews with workers, independent
measurements of radiation and contamination levels, and
review of records.
The review and inspection processes should be closely
coupled, with reviewers of the application and inspectors
and inspectors exchanging experiences.
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Part 3. Principles of Radiation Protection
138
Inspections
Adequate preparation before the inspection is essential.
The inspector should review the documents submitted
with the application, and the history of the facility.
Appropriate monitoring instruments to measure radiation
and contamination levels should be obtained as necessary.
An inspection plan as a guide for inspection of the
organization's safety programme should be prepared. The
plan should prioritize inspection of potential problem areas
in the facility.
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Inspections
Unannounced inspections
The advantage of an unannounced inspection is that it
provides the opportunity to see the facility operating
under its usual conditions.
The disadvantages are that the key personnel may not be
available, or part of the facility may not be operating.
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Inspections
The facility and operating programmes should be inspected
in detail to determine whether they conform to those
described in the application.
The inspector should verify that the staff present are as
described in the application.
The inspector should carefully review records.
The inspector should interview key members of the staff to elicit
information which helps the inspector assess the status of
protection and safety
Nuclear Medicine
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Inspections
The frequency of routine inspections for each facility should
be planned according to the hazards and risks associated with
the operation of that facility and its previous compliance history.
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142
Frequency of Regular Inspections
Category A
High safety risk; every 1 – 3 years
Category B
Medium safety risk; every 3 – 5 years
Category C
Low safety risk; every 5 – 10 years
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143
Inspections
1.
2.
3.
4.
5.
6.
7.
Nuclear Medicine
Identifying information
Verification of safety
Verification of worker protection
Verification of public protection
Emergency preparedness
Medical exposure
Records
Part 3. Principles of Radiation Protection
144
Inspections
Verification of safety:
•
•
•
•
•
•
•
•
Nuclear Medicine
Description of radioactive material in use
Description of measuring and handling equipment
Facility design
Safety control and equipment design
Warning systems
Safety operation-management
Safety operation-technical
Investigation and quality assurance
Part 3. Principles of Radiation Protection
145
Inspections
Verification of Occupational Protection
•
•
•
Nuclear Medicine
Classification of areas
Local rules and supervision
Monitoring
Part 3. Principles of Radiation Protection
146
Inspections
Medical exposure:
• Responsibilities
• Justification
• Optimization
• Calibration
• Clinical dosimetry
• Quality assurance
• Dose constraints
• Investigation of accidental medical exposures
• Guidance level
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147
Enforcement

Enforcement is

Action taken by the Regulatory Authority to
ensure that the responsible party corrects
non-compliance with regulatory
requirements
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Graded Enforcement Actions

Based on threat to health and safety
Operations likely not safe
Potential threat of health and safety
No immediate threat to health and safety
(usually regulatory infraction)
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Graded Enforcement Actions
No immediate threat to health and safety
(usually regulatory infraction)

Informal or formal instructions to correct the
infraction Operations may continue while
corrective measures are taken

Informal oral instruction should be followed in
writing
Examples might be a non-complying or deteriorated warning
sign for a controlled area, or the calibration of an instrument
not having been carried out by the due date.
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150
Graded Enforcement Actions
Potential threat of health and safety

Suspension of or restrictions on operations
until regulatory infraction or safety condition is
corrected
An example might be a requirement to replace badly cracked
and poor quality flooring material in a ward room used for
thyroid cancer patients treated with I-131.
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151
Graded Enforcement Actions
Operations likely not safe


Licensee shows a record of poor performance
or adverse safety conditions
Suspension of or restrictions on operations
An example might be the unauthorised use of lung ventilation
studies in a room without appropriate air pressure controls
used also for ultrasound scans of pregnant women.
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152
Questions?
Nuclear Medicine
Part 3. Principles of Radiation Protection
153
Discussion
Give examples of non-justified situations in:
• The practice of nuclear medicine
• Examination or treatment of a single patient
Nuclear Medicine
Part 3. Principles of Radiation Protection
154
Discussion
A nuclear medicine department which has treated
hyperthyroid patients on an outpatient basis for some
time proposes to extend its services to include
treatment of thyroid cancer patients. A two room area
is to be designated for therapy in-patients. What
information should be submitted to the Regulatory
Authority to allow this extension of the work of the
department to be authorised?
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Part 3. Principles of Radiation Protection
155
Discussion
A nuclear medicine department in a hospital had
taken delivery of a single dose vial of I-131 for
treatment of a thyroid cancer patient. A different
hospital had ordered a different activity amount of I131 from the same supplier (external to the country).
The wrong vial was delivered by courier to the first
hospital and the dose was administered to the
patient. The error was discovered when checks at
the second hospital showed the incorrect activity in
the vial received by them.
Appropriate investigation and enforcement
action?
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156
Where to Get More Information?

Further Readings:





IAEA Basic Safety Standards, Interim Edition (2011)
ICRP publication 103, 2007
RPOP website: www.rpop.iaea.org
WHO/IAEA. Manual on Radiation Protection in Hospital and
General Practices. Volume 1, Basic Requirements
IAEA. Practice-specific Model Regulations on Radiation
Safety in Nuclear Medicine
Nuclear Medicine
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157