ISO 16637:2016

Radiological protection — Monitoring and internal dosimetry for staff members exposed to medical radionuclides as unsealed sources

ISO 16637:2016 specifies the minimum requirements for the design of professional programmes to monitor workers exposed to the risk of internal contamination via inhalation by the use of radionuclides as unsealed sources in nuclear medicine imaging and therapy departments. It establishes principles for the development of compatible goals and requirements for monitoring programmes and, when adequate, dose assessment. It presents procedures and assumptions for the risk analysis, for the monitoring programmes, and for the standardized interpretation of monitoring data. ISO 16637:2016 addresses the following items: a) purposes of monitoring and monitoring programmes; b) description of the different categories of monitoring programmes; c) quantitative criteria for conducting monitoring programmes; d) suitable methods for monitoring and criteria for their selection; e) information that has to be collected for the design of a monitoring programme; f) general requirements for monitoring programmes (e.g. detection limits, tolerated uncertainties); g) frequencies of measurements; h) procedures for dose assessment based on reference levels for routine and special monitoring programmes; i) assumptions for the selection of dose-critical parameter values; j) criteria for determining the significance of individual monitoring results; k) interpretation of workplace monitoring results; l) uncertainties arising from dose assessments and interpretation of bioassays data; m) reporting/documentation; n) quality assurance. ISO 16637:2016 does not address the following: - monitoring and internal dosimetry for the workers exposed to laboratory use of radionuclides such as radioimmunoassay techniques; - monitoring and internal dosimetry for the workers involved in the operation, maintenance, and servicing of PET cyclotrons; - detailed descriptions of measuring methods and techniques; - dosimetry for litigation cases; - modelling for the improvement of internal dosimetry; - the potential influence of medical treatment of the internal contamination; - the investigation of the causes or implications of an exposure; - dosimetry for ingestion exposures and for contaminated wounds.

Radioprotection — Surveillance et dosimétrie interne des travailleurs exposés lors des utilisations médicales des radioéléments en sources non scellées

L'ISO 16637:2016 décrit les exigences minimales permettant d'établir des programmes de surveillance professionnelle des travailleurs exposés à un risque de contamination interne par inhalation lors de l'utilisation, à des fins diagnostiques ou thérapeutiques, de radionucléides en sources non scellées dans les services de médecine nucléaire. Elle établit des principes pour l'élaboration d'objectifs et d'exigences compatibles avec les programmes de surveillance et, le cas échéant, l'estimation de la dose. Elle présente les procédures et les hypothèses considérées pour l'analyse du risque, pour la mise en place des programmes de surveillance et pour l'interprétation normalisée des données de surveillance. L'ISO 16637:2016 traite des points suivants: a) objectifs de la surveillance et des programmes de surveillance; b) description des différentes catégories de programmes de surveillance; c) critères quantitatifs pour la conduite des programmes de surveillance; d) méthodes valables pour la surveillance et leurs critères de sélection; e) informations à collecter pour l'élaboration d'un programme de surveillance; f) exigences générales pour les programmes de surveillance (par exemple? limites de détection, incertitudes tolérées); g) fréquence des mesurages; h) procédures d'estimation dosimétrique fondées sur des niveaux de référence pour les programmes de surveillance de routine et post-incidentelle; i) hypothèses pour le choix des paramètres influençant l'estimation dosimétrique; j) critères pour déterminer si les résultats de la surveillance individuelle sont significatifs; k) interprétation des résultats de la surveillance aux postes de travail; l) incertitudes liées aux estimations de la dose et à l'interprétation des données de mesurage in vivo et d'analyse in vitro; m) compte-rendu/documentation; n) assurance de la qualité. L'ISO 16637:2016 ne traite pas des points suivants: - surveillance et dosimétrie interne pour les travailleurs exposés lors des utilisations en laboratoire de radionucléides, par exemple lors des dosages radio-immunologiques; - surveillance et dosimétrie interne pour les travailleurs impliqués dans l'exploitation, la maintenance et l'entretien des cyclotrons TEP; - descriptions détaillées des méthodes et techniques de mesurage; - dosimétrie dans les cas litigieux; - modélisation pour l'amélioration de la dosimétrie interne; - influence potentielle d'un traitement médical de la contamination interne; - investigation des causes ou des conséquences d'une exposition; - dosimétrie pour les expositions par ingestion et par plaies contaminées.

General Information

• Status: Published
• Publication Date: 17-Feb-2016
• ICS: 13.280 - Radiation protection
• Technical Committee: ISO/TC 85/SC 2 - Radiological protection
• Drafting Committee: ISO/TC 85/SC 2/WG 13 - Monitoring and dosimetry for internal exposure
• Current Stage: 9093 - International Standard confirmed

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 16637
First edition
2016-02-15
Radiological protection — Monitoring
and internal dosimetry for staff
members exposed to medical
radionuclides as unsealed sources
Radioprotection — Surveillance et dosimétrie interne des travailleurs
exposés lors des utilisations médicales des radioéléments en sources
non scellées
Reference number
ISO 16637:2016(E)
©
ISO 2016

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ISO 16637:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2016 – All rights reserved

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ISO 16637:2016(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 5
5 Purpose and need for monitoring programmes in nuclear medical diagnosis and therapy 6
5.1 General . 6
5.2 Assessment of the level of likely exposures . 6
5.3 Monitoring programmes . 7
5.3.1 General. 7
5.3.2 Confirmatory monitoring programmes . 7
5.3.3 Routine monitoring programmes. 8
5.3.4 Triage monitoring programmes . 8
5.3.5 Task-related monitoring programmes . 8
5.3.6 Special monitoring programmes . 8
5.3.7 Implementation of a monitoring programme. 9
6 Common radionuclides .10
7 Reference levels .10
8 Routine monitoring programmes .11
8.1 General aspects .11
8.2 Individual monitoring .12
8.3 Methods and monitoring intervals .12
9 Triage monitoring programmes .13
10 Special Monitoring programmes .13
10.1 General aspects .13
10.2 Workplace monitoring . .14
10.3 Individual monitoring .14
11 Confirmatory monitoring programmes .15
11.1 General aspects .15
11.2 Workplace monitoring . .15
11.3 Individual monitoring .15
12 Measurement techniques and performance criteria .15
12.1 General .15
12.2 Measurements performed in a laboratory specialised for radiobioassay .16
12.2.1 In vitro.16
12.2.2 In vivo .16
12.2.3 Quality assurance and quality control for bioassay laboratories .16
12.3 Measurements performed in nuclear medicine service .17
13 Procedure for the assessment of exposures .17
13.1 Interpretation of individual monitoring data for dose assessment .17
13.1.1 General.17
13.1.2 Dose assessment based on routine monitoring .17
13.1.3 Dose assessment based on special monitoring .17
13.2 Software tools .22
13.3 Uncertainties .22
13.4 Quality assurance of the assessment process .22
14 Reporting and documentation .23
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ISO 16637:2016(E)

14.1 Reporting results for in vitro measurements .23
14.2 Reporting results for in vivo measurements .23
14.3 Documentation of the dose assessment .24
Annex A (informative) IAEA Safety Guide RS-G-1.2 “decision factor” .25
Bibliography .27
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ISO 16637:2016(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 85, Nuclear energy, nuclear technologies, and
radiological protection, Subcommittee SC 2, Radiological protection.
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ISO 16637:2016(E)

Introduction
In the course of employment, individuals might work with radioactive materials that, under certain
circumstances, could be taken into the body. Protecting workers against risks of incorporated
radionuclides requires the monitoring of potential intakes and/or the quantification of actual intakes
and exposures. The doses resulting from internal radiation exposure arising from contamination
by radioactive substances cannot be measured directly. The selection of measures and programmes
for this purpose requires decisions concerning methods, techniques, frequencies, etc. for activity
measurements and dose assessment. The criteria permitting the evaluation of the necessity of such a
monitoring programme or for the selection of methods and frequencies of monitoring usually depend
upon the legislation, the purpose of the radiation protection programme, the probabilities of potential
radionuclide intakes, and the characteristics of the materials handled.
For these reasons, ISO standards establishing requirements for monitoring programmes (ISO 20553),
laboratory requirements (ISO 28218), and dose assessment (ISO 27048) have been developed. These can
be applied in a straightforward manner to many workplaces where internal contamination may occur.
In order to apply these standards to staff involved in diagnostic or therapeutic uses of radionuclides
in medicine, the short effective half-life of radionuclides commonly used for these purposes and the
distance between nuclear medicine department and in vivo counting facilities or radio-analytical
laboratories shall be taken into account. Consequently, guidance on the application of the three
International Standards cited above to nuclear medicine staff was requested by a number of countries.
This International Standard establishes criteria to determine whether intake monitoring is required
for staff exposed to medical radionuclides as unsealed sources. It also establishes requirements on the
design of such monitoring programmes, associated dose assessments, and laboratory requirements.
Recommendations of international expert bodies and international experience with the practical
application of these recommendations in radiological protection programmes have been considered in
the development of this International Standard. Its application facilitates the exchange of information
between authorities, supervisory institutions, and employers. This International Standard is not a
substitute for legal requirements.
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INTERNATIONAL STANDARD ISO 16637:2016(E)
Radiological protection — Monitoring and internal
dosimetry for staff members exposed to medical
radionuclides as unsealed sources
1 Scope
This International Standard specifies the minimum requirements for the design of professional
programmes to monitor workers exposed to the risk of internal contamination via inhalation by
the use of radionuclides as unsealed sources in nuclear medicine imaging and therapy departments.
It establishes principles for the development of compatible goals and requirements for monitoring
programmes and, when adequate, dose assessment. It presents procedures and assumptions for the risk
analysis, for the monitoring programmes, and for the standardized interpretation of monitoring data.
This International Standard addresses the following items:
a) purposes of monitoring and monitoring programmes;
b) description of the different categories of monitoring programmes;
c) quantitative criteria for conducting monitoring programmes;
d) suitable methods for monitoring and criteria for their selection;
e) information that has to be collected for the design of a monitoring programme;
f) general requirements for monitoring programmes (e.g. detection limits, tolerated uncertainties);
g) frequencies of measurements;
h) procedures for dose assessment based on reference levels for routine and special monitoring
programmes;
i) assumptions for the selection of dose-critical parameter values;
j) criteria for determining the significance of individual monitoring results;
k) interpretation of workplace monitoring results;
l) uncertainties arising from dose assessments and interpretation of bioassays data;
m) reporting/documentation;
n) quality assurance.
This International Standard does not address the following:
— monitoring and internal dosimetry for the workers exposed to laboratory use of radionuclides such
as radioimmunoassay techniques;
— monitoring and internal dosimetry for the workers involved in the operation, maintenance, and
servicing of PET cyclotrons;
— detailed descriptions of measuring methods and techniques;
— dosimetry for litigation cases;
— modelling for the improvement of internal dosimetry;
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ISO 16637:2016(E)

— the potential influence of medical treatment of the internal contamination;
— the investigation of the causes or implications of an exposure;
— dosimetry for ingestion exposures and for contaminated wounds.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 20553, Radiation protection — Monitoring of workers occupationally exposed to a risk of internal
contamination with radioactive material
ISO 27048:2011, Radiation protection — Dose assessment for the monitoring of workers for internal
radiation exposure
ISO 28218, Radiation protection — Performance criteria for radiobioassay
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99, ISO 20553,
ISO 28218 and ISO 27048 and the following apply.
3.1
absorption
movement of material to blood regardless of mechanism, generally applied to dissociation of particles
and uptake into blood of soluble substances and material dissociated from particles
3.2
absorption type F
as defined by ICRP, deposited materials that have high (fast) rates of absorption (3.1) into body fluids
from the respiratory tract
3.3
absorption type M
as defined by ICRP, deposited materials that have intermediate (moderate) rates of absorption (3.1) into
body fluids from the respiratory tract
3.4
activity
number of spontaneous nuclear transformations per unit time
Note 1 to entry: The activity is stated in becquerel (Bq), i.e. the number of transformations per second.
3.5
activity median aerodynamic diameter
AMAD
value of aerodynamic diameter such that 50 % of the airborne activity (3.4) in a specified aerosol is
associated with particles smaller than the AMAD, and 50 % of the activity is associated with particles
larger than the AMAD
Note 1 to entry: The aerodynamic diameter of an airborne particle is the diameter that a sphere of unit density
would need to have in order to have the same terminal velocity when settling in air as the particle of interest.
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ISO 16637:2016(E)

3.6
contamination
activity (3.4) of radionuclides present on surfaces, or within solids, liquids or gases (including the
human body), where the presence of such radioactive material is unintended or undesirable
3.7
decision threshold
fixed value of the measurand by which, when exceeded by the result of an actual measurement of a
measurand quantifying a physical effect, it is decided that the physical effect is present
3.8
detection limit
smallest true value of the measurand which is detectable by the measuring method
3.9
annual dose
committed effective dose (3.11) resulting from all intakes (3.14) occurring during a calendar year
Note 1 to entry: The term “annual dose” is not used to represent the dose received in a year from all preceding
intakes.
3.10
committed equivalent dose
sum of the products of the total doses absorbed by an organ or a tissue from radiation types, integrated
over the commitment period following the intake (3.14) of a radionuclide, and the appropriate radiation
weighting factors
3.11
committed effective dose
sum of the products of the committed organ or tissue equivalent doses and the appropriate tissue
weighting factors
Note 1 to entry: In the context of this International Standard, the commitment period [integration time following
the intake (3.14)] is taken to be 50 years.
3.12
excretion function
function describing the fraction of an intake (3.14) excreted per day after a given time has elapsed since
the intake occurred
3.13
event = incident
any unintended occurrence, including operating error, equipment failure or other mishap, the
consequences or potential consequences of which are not negligible from the point of view of protection
or safety
3.14
intake
activity (3.4) of a radionuclide taken into the body in a given time period or as a result of a given event
3.15
in vitro analyses
indirect measurements
analyses including measurements of radioactivity present in biological samples taken from an
individual
Note 1 to entry: These include urine, faeces, and nasal samples; in special monitoring programmes (3.21), samples
of other materials, such as blood and hair, may be taken.
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ISO 16637:2016(E)

3.16
in vivo measurements
direct measurements
measurement of radioactivity present in the human body, carried out using detectors to measure the
radiation emitted
Note 1 to entry: Normally, the measurement devices are whole-body or partial-body (e.g. lung, thyroid) counters.
3.17
monitoring
measurements made for the purpose of assessment or control of exposure to radioactive material and
the interpretation of the results
Note 1 to entry: This International Standard distinguishes five different categories of monitoring programmes,
namely, routine monitoring programme (3.18), task-related monitoring programme (3.19), triage monitoring
programme (3.20), special monitoring programme (3.21), and confirmatory monitoring programme (3.22).
Note 2 to entry: This International Standard distinguishes two different types of monitoring, namely, individual
monitoring (3.23) and workplace monitoring (3.24).
3.18
routine monitoring programme
monitoring programme associated with continuing operations and intended to demonstrate that
working conditions, including the levels of individual dose, remain satisfactory, and to meet regulatory
requirements
3.19
task-related monitoring programme
monitoring programme related to a specific operation, to provide information on a specific operation of
limited duration, or following major modifications applied to the installations or operating procedures,
or to confirm that the routine monitoring programme (3.18) is suitable
3.20
triage monitoring programme
monitoring programme consist of frequent measurements performed in the nuclear medicine centres
that does not enable one to calculate a dose but to verify that a given threshold of potential intake (3.14)
is not surpassed
3.21
special monitoring programme
monitoring programme performed to quantify significant exposures following actual or suspected
abnormal events
3.22
confirmatory monitoring programme
monitoring programme carried out to confirm assumptions about working conditions, for example,
that significant intakes (3.14) have not occurred
3.23
individual monitoring
monitoring by means of equipment worn by individual workers, by measurement of the quantities
of radioactive materials in or on the bodies of individual workers, or by measurement of radioactive
material excreted by individual workers
3.24
workplace monitoring
monitoring using measurements made in the working environment
3.25
monitoring interval
period between two consecutive times of measurement
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ISO 16637:2016(E)

3.26
quality assurance
planned and systematic actions necessary to provide adequate confidence that a process, measurement,
or service satisfy given requirements for quality such as those specified in a licence
3.27
quality control
part of quality assurance (3.26) intended to verify that systems and components correspond to
predetermined requirements
3.28
quality management
all activities of the overall management function that determine the quality policy, objectives, and
responsibilities and that implement them by means such as quality planning, quality control (3.27),
quality assurance (3.26), and quality improvement within the quality system
3.29
reference level
investigation level (3.30) or recording level (3.29)
3.30
recording level
level of dose, exposure, or intake (3.14) specified by the employer or the regulatory authority, at or
above which values of dose received by workers are to be entered in their individual records
3.31
investigation level
level of dose, exposure, or intake (3.14) at or above which investigation has to be made in order to reduce
the uncertainty associated with the dose assessment
3.32
retention function
function describing the fraction of an intake (3.14) present in the body or in a tissue, organ, or region of
the body after a given time has elapsed since the intake occurred
3.33
scattering factor
geometric standard deviation of the lognormal distribution of bioassay measurements
3.34
time of measurement
time at which the measurement begins
4 Symbols and abbreviated terms
A Value of the activity detection limit (in becquerel) for routine measurements
DL
AMAD Activity median aerodynamic diameter
3 -1
B Breathing rate of worker (m ·h )
-3
C Airborne concentration of radionuclide (Bq·m )
m
DL Detection limit
E(50) Committed effective dose accumulated for an integration period of 50 years following an unit intake (Sv)
e(50) Dose coefficient i.e. committed effective dose accumulated for an integration period of 50 years follow-
-1
ing a unit intake (Sv·Bq )
m(t) Predicted value of the measured quantity at time, t, for unit intake (excretion or retention function at
time t for unit intake)
I Intake (Bq)
IAEA International Atomic Energy Agency
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ISO 16637:2016(E)

ICRP International Commission on Radiological Protection
ΔT Duration of the monitoring interval between two measurements in a routine monitoring programme
(in days)
T Time spent by the worker in the radioactive atmosphere (h)
work
5 Purpose and need for monitoring programmes in nuclear medical diagnosis
and therapy
5.1 General
The purpose of monitoring, in general, is to verify and document that the worker is protected adequately
against risks from radionuclide intakes and the protection complies with legal requirements. Therefore,
it forms part of the overall radiation protection programme, which should start with an assessment to
identify work situations in which there is a risk of radionuclide intake by workers, and to quantify the
annual likely intake of radioactive material and the resulting committed effective dose. Decisions about
the need for monitoring and the design of the monitoring programme should be made in the light of
such a risk assessment.
5.2 Assessment of the level of likely exposures
It is necessary to assess the likely magnitude of exposures without taking into account personal
protective measures. If available, this assessment can be done on the basis of results of earlier
monitoring programmes (individual or workplace monitoring) and/or on measurements performed at
the workplace to characterize the radiological conditions.
In nuclear medicine, workers can be contaminated by inhalation of volatile compounds (mainly
radioiodine) or aerosols. As a result, individual monitoring for internal contamination may be necessary
[1]
for those workers who regularly work with large activities of volatile radioactive materials.
In order to assess the level of likely exposures, quantification of airborne contamination should be
performed in departments where I-131 is used in large amount, i.e. for therapy or where aerosols are
used for pulmonary inhalation examination.
To assess the risk of I-131 inhalation, air sampling should be performed in areas where there is a
potential for airborne radioactivity. These areas may include the following:
— hot laboratory;
— radioiodine treatment rooms and adjacent areas;
— facility radioactive waste and effluent storage areas.
For a specific radionuclide, the likely committed
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 16637
ISO/TC 85/SC 2 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2014-01-15 2014-04-15
Radiological protection — Monitoring and internal
dosimetry for staff exposed to medical radionuclides as
unsealed sources
Radioprotection — Surveillance et dosimétrie interne des travailleurs exposés lors des utilisations
médicales des radioéléments en sources non scellées
ICS: 13.280
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 16637:2013(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2013

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ISO/DIS 16637:2013(E)

Copyright notice
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ISO/DIS 16637
Contents Page
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 6
5 Purpose and need for monitoring programmes in nuclear medical diagnosis and therapy . 6
5.1 General . 6
5.2 Assessment of the level of likely exposures . 7
5.3 Monitoring programmes . 9
5.3.1 General . 9
5.3.2 Confirmatory monitoring programmes . 10
5.3.3 Triage monitoring programmes . 10
5.3.4 Routine monitoring programmes . 10
5.3.5 Special monitoring programmes . 10
5.3.6 Task-related monitoring programmes . 10
6 General aspects . 11
7 Reference levels . 13
8 Routine Monitoring programmes . 14
8.1 General aspects . 14
8.2 Individual monitoring . 14
8.3 Methods and time intervals . 15
8.4 Derived recording level . 16
9 Triage monitoring programmes . 16
10 Special Monitoring programmes . 17
10.1 General aspect . 17
10.2 Workplace monitoring . 17
10.3 Individual monitoring . 17
11 Confirmatory monitoring programmes . 18
11.1 General aspect . 18
11.2 Workplace monitoring . 18
11.3 Individual monitoring . 19
12 Measurement techniques and performance criteria . 19
12.1 General . 19
12.2 In vitro . 19
12.3 In vivo . 20
12.4 Quality assurance and quality control for bioassay laboratories . 20
13 Procedure for the assessment of exposures . 21
13.1 Interpretation of workplace monitoring data for dose assessment . 21
13.2 Interpretation of individual monitoring data for dose assessment . 21
13.2.1 General . 21
13.2.2 Dose assessment based on routine monitoring . 21
13.2.3 Dose assessment based on special monitoring . 21
13.3 Software tools . 26
13.4 Uncertainties . 26
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ISO/DIS 16637
13.5 Quality assurance of the assessment process . 27
14 Reporting and Documentation . 27
14.1 Reporting results for in vitro measurements . 27
14.2 Reporting results for in vivo measurements . 27
14.3 Documentation of the dose assessment . 28
Annex A Example of d estimation (informative) . 29
j
Bibliography . 30


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ISO/DIS 16637
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
ISO 16637 was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies, and
radiological protection, Subcommittee SC 2, Radiological protection.
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ISO/DIS 16637
Introduction
In the course of employment, individuals might work with radioactive materials that, under certain
circumstances, could be taken into the body. Protecting workers against risks of incorporated radionuclides
requires the monitoring of potential intakes and/or the quantification of actual intakes and exposures. The
doses resulting from internal radiation exposure arising from contamination by radioactive substances cannot
be measured directly. The selection of measures and programmes for this purpose requires decisions
concerning methods, techniques, frequencies etc. for measurements and dose assessment. The criteria
permitting the evaluation of the necessity of such a monitoring programme or for the selection of methods and
frequencies of monitoring usually depend upon the legislation, the purpose of the radiation protection
programme, the probabilities of potential radionuclide intakes, and the characteristics of the materials handled.
For these reasons, three ISO standards for the monitoring programmes (20553:2006), for the laboratory
requirements (28218:2010), and for the dose assessment (27048:2011) have been developed and can be
applied in a straightforward manner to many workplaces where internal contamination may occur. However,
their application for the staff involved in the diagnostic or therapeutic use of radionuclides in medicine requires
account to be taken of special aspects resulting from the short effective half-times of the nuclides in use and
from the distances between department of nuclear medicine and whole body and thyroid counting facilities or
laboratories undertaking spectrometry on urine samples. Consequently, guidance for the practical application
of the three standards cited above to the nuclear medicine staff was requested by a number of countries.
This International Standard offers guidance for the decision whether a monitoring is required for staff exposed
to medical radionuclides as unsealed sources and how it should be designed, for the dose assessment and
for the laboratories requirements. Recommendations of international expert bodies and international
experience with the practical application of these recommendations in radiological protection programmes
have been considered in the development of this International Standard. Its application facilitates the
exchanges of information between authorities, supervisory institutions and employers. The International
Standard is not a substitute for legal requirements.

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DRAFT INTERNATIONAL STANDARD ISO/DIS 16637

Radiological protection — Monitoring and internal dosimetry for
staff exposed to medical radionuclides as unsealed sources
1 Scope
This International Standard specifies the minimum requirements for the design of professional programmes to
monitor workers exposed to the risk of internal exposure by the use of radionuclides as unsealed sources in
nuclear medicine departments and establishes principles for the development of compatible goals and
requirements for monitoring programmes and, when adequate, dose assessment. It presents procedures and
assumptions for the risk analysis, for the monitoring programmes and for the standardised interpretation of
monitoring data.
This International Standard addresses the following items:
a) purposes of monitoring and of monitoring programmes;
b) description of the different categories of monitoring programmes;
c) quantitative criteria for conducting monitoring programmes;
d) suitable methods for monitoring and criteria for their selection;
e) information that has to be collected for the design of a monitoring programme;
f) general requirements for monitoring programmes (e.g. detection limits, tolerated uncertainties);
g) frequencies of measurements;
h) procedures for dose assessment based on reference levels for routine and special monitoring
programmes;
i) assumptions for the selection of dose-critical parameter values;
j) criteria for determining the significance of monitoring results;
k) interpretation of workplace monitoring results;
l) uncertainties arising from dose assessments and interpretation of bioassays data;
m) reporting/documentation;
n) quality assurance.
This International Standard does not address
 monitoring and internal dosimetry for the workers exposed to laboratory use of radionuclides such as
radioimmunoassay techniques;
 monitoring and internal dosimetry for the workers involved in the operation, maintenance and servicing of
PET cyclotrons;
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ISO/DIS 16637
 detailed descriptions of measuring methods and techniques;
 dosimetry for litigation cases;
 modelling for the improvement of internal dosimetry;
 the potential influence of medical treatment of the internal contamination;
 the investigation of the causes or implications of an exposure;
 dosimetry for ingestion exposures.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms
(VIM)
ISO 20553:2006, Radiation protection — Monitoring of workers occupationally exposed to a risk of internal
contamination with radioactive material
ISO 28218:2010, Radiation protection — Performance criteria for radiobioassay
ISO 27048:2011, Radiation protection — Dose assessment for the monitoring of workers for internal radiation
exposure
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99, ISO 20553,
ISO 28218 and ISO 27048 and the following apply.
3.1
absorption
absorption characterised by its rate in the deposited material and which, depending on the material, is
denoted as being of type F, M or S
3.2
absorption type F
deposited materials that have high (fast) rates of absorption into body fluids from the respiratory tract
3.3
absorption type M
deposited materials that have intermediate (moderate) rates of absorption into body fluids from the respiratory
tract
3.4
absorption type S
deposited materials that have low (slow) rates of absorption into body fluids from the respiratory tract
3.5
activity
number of spontaneous nuclear transformations per unit time
Note 1 to entry: The activity is stated in becquerel (Bq), i.e. the number of transformations per second.
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ISO/DIS 16637
3.6
activity median aerodynamic diameter
AMAD
value of aerodynamic diameter such that 50 % of the airborne activity in a specified aerosol is associated with
particles smaller than the AMAD, and 50 % of the activity is associated with particles larger than the AMAD
Note 1 to entry: The aerodynamic diameter of an airborne particle is the diameter that a sphere of unit density would need
to have in order to have the same terminal velocity when settling in air as the particle of interest.
3.7
contamination
activity of radionuclides present on surfaces, or within solids, liquids or gases (including the human body),
where the presence of such radioactive material is unintended or undesirable
3.8
critical value
maximum value for the result of a single measurement in a monitoring programme where it is safe to assume
that the corresponding extrapolated annual dose does not exceed a predefined dose level
3.9
decision threshold
fixed value of the measurand by which, when exceeded by the result of an actual measurement of a
measurand quantifying a physical effect, it is decided that the physical effect is present
3.10
detection limit
smallest true value of the measurand which is detectable by the measuring method
3.11
annual dose
committed effective dose resulting from all intakes occurring during a calendar year
Note 1 to entry: The term “annual dose” is not used to represent the dose received in a year from all preceding intakes.
3.12
committed effective dose
sum of the products of the committed organ or tissue equivalent doses and the appropriate tissue weighting
factors. In the context of this International Standard, the commitment period (integration time following the
intake) is taken to be 50 years
3.13
effective dose
sum of the products of the committed organ or tissue equivalent doses and the appropriate tissue weighting
factors
3.14
excretion function
fraction of an intake excreted per day after a given time has elapsed since the intake occurred
3.15
event = incident
any unintended occurrence, including operating error, equipment failure or other mishap, the consequences or
potential consequences of which are not negligible from the point of view of protection or safety
3.16
intake
activity of a radionuclide taken into the body in a given time period or as a result of a given event
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ISO/DIS 16637
3.17
in vitro analyses
indirect measurements
analyses including measurements of radioactivity present in biological samples taken from an individual
Note 1 to entry: These include urine, faeces and nasal samples; in special monitoring programmes, samples of other
materials such as blood and hair may be taken.
3.18
in vivo measurement
direct measurements
measurement of radioactivity present in the human body carried out using detectors to measure the radiation
emitted
Note 1 to entry: Normally, the measurement devices are whole-body or partial-body (e.g. lung, thyroid) counters.
3.19
monitoring
measurements made for the purpose of assessment or control of exposure to radioactive material and the
interpretation of the results
Note 1 to entry: This International Standard distinguishes five different categories of monitoring programmes, namely
routine monitoring programme (3.20), task-related monitoring programme (3.21), triage monitoring programme
(3.22), special monitoring programme (3.23), and confirmatory monitoring programme (3.24).
Note 2 to entry: This International Standard distinguishes two different types of monitoring, namely individual monitoring
(3.25) and workplace monitoring (3.26), which feature in each category.
3.20
routine monitoring programme
monitoring programme associated with continuing operations and intended to demonstrate that working
conditions, including the levels of individual dose, remain satisfactory, and to meet regulatory requirements
3.21
task-related monitoring programme
monitoring programme related to a specific operation, to provide information on a specific operation of limited
duration, or following major modifications applied to the installations or operating procedures, or to confirm
that the routine monitoring programme is suitable
3.22
triage monitoring programme
monitoring programme consist of frequent measurements performed in the nuclear medicine centres that does
not enable one to calculate a dose but to verify that a given threshold of potential intake is not surpassed
3.23
special monitoring programme
monitoring programme performed to quantify significant exposures following actual or suspected abnormal
events
3.24
confirmatory monitoring programme
monitoring programme carried out to confirm assumptions about working conditions, for example that
significant intakes have not occurred
3.25
individual monitoring
monitoring by means of equipment worn by individual workers, by measurement of the quantities of
radioactive materials in or on the bodies of individual workers, or by measurement of radioactive material
excreted by individual workers
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ISO/DIS 16637
3.26
workplace monitoring
monitoring using measurements made in the working environment
3.27
monitoring interval
period between two consecutive times of measurement
3.28
quality assurance
planned and systematic actions necessary to provide adequate confidence that a process, measurement or
service satisfy given requirements for quality such as those specified in a licence
3.29
quality control
part of quality assurance intended to verify that systems and components correspond to predetermined
requirements
3.30
quality management
all activities of the overall management function that determine the quality policy, objectives and
responsibilities, and that implement them by means such as quality planning, quality control, quality assurance
and quality improvement within the quality system
3.31
reference level
investigation level or recording level
3.32
recording level
level of dose, specified by the employer or the regulatory authority, at or above which values of dose received
by workers are to be entered in their individual records
3.33
investigation level
level of dose, exposure or intake at or above which investigation has to be made in order to reduce the
uncertainty associated with the dose assessment
3.34
retention function
function describing the fraction of an intake present in the body or in a tissue, organ or region of the body after
a given time has elapsed since the intake occurred
3.35
scattering factor
geometric standard deviation of the lognormal distribution of bioassay measurements
3.36
time of measurement
in vitro analysis time at which the biological sample (e.g. urine, faeces) was taken from the individual
concerned
3.37
time of measurement
in vivo analysis time at which the measurement begins
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ISO/DIS 16637
4 Symbols and abbreviated terms
A Mathematical symbol for the detection limit, used in equations
DL
Aj Cumulative activity of the radionuclide j present in the workplace over the course of a year (Bq)
AMAD Activity median aerodynamic diameter
3 -1
B Breathing rate of worker (m .h )
-3
Cm Airborne concentration of radionuclide (Bq.m )
dj Decision factor for radionuclide j (mSv)
D Decision factor for all radionuclides in the workplace (mSv)
DL Detection limit
DRL Derived recording level
E(50) Committed effective dose (Sv)
-1
e(50) Effective dose coefficient following a unit intake (Sv.Bq )
-1
e (50) Effective dose coefficient following a unit intake for radionuclide j (Sv.Bq )
j
E(t) Value of the excretion function at time, t, (in days) after a unit intake
f Physical form safety factor based on the physical and chemical properties of the material being
fS
handled
f Handling safety factor based on the experience of the operation being performed and the form of the
hS
material
f Protection safety factor based on the use of permanent laboratory protective equipment
pS
I Intake (Bq)
R(t) Value of the retention function at time, t, (in days) after a unit intake
T Time interval between two measurements in a routine monitoring programme (in days)
T Time spends by the worker in the radioactive atmosphere (h)
work
5 Purpose and need for monitoring programmes in nuclear medical diagnosis and
therapy
5.1 General
The purpose of monitoring, in general, is to verify and document that the worker is protected adequately
against risks from radionuclide intakes and the protection complies with legal requirements. Therefore, it forms
part of the overall radiation protection programme, which should starts with an assessment to identify work
situations in which there is a risk of radionuclide intake by workers, and to quantify the annual likely intake of
radioactive material and the resulting committed effective dose. Decisions about the need for monitoring and
the design of the monitoring programme should be made in the light of such a risk assessment.
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ISO/DIS 16637
5.2 Assessment of the level of likely exposures
It is necessary to assess the likely magnitude of exposures without taking into account personal protective
measures. If available, this assessment can be done on the basis of results of earlier monitoring programmes
(individual or workplace monitoring) and/or on measurements perform at the workplace to characterize the
radiological conditions.
In nuclear medicine, workers can be contaminated by inhalation of volatile compounds (mainly radioiodine), or
aerosols. As a result, individual monitoring for internal contamination may be necessary for those workers who
[1]
regularly work with large activities of volatile radioactive materials .
In order to assess the level of likely exposures, quantification of airborne contamination should be performed
in departments where I-131 is used in large amount i.e. for therapy or where aerosols are used for pulmonary
inhalation examination.
To assess the risk of I-131 inhalation, aerosol sampling shall be performed in areas where there is a potential
for airborne radioactivity. These areas include:
 hot laboratory;
 radioiodine treatment rooms and adjacent areas;
 radioactive waste collection areas and waste water treatment plant.
For a specific radionuclide j, the likely committed effective dose due to airborne radioactivity for a worker can
be calculated by the following Equation:
I  e 50
j j
E 50 (1)
j
0,00
where
E (50) is the commited effective dose (mSv);
j
I is the intake (Bq) and;
j
-1
e (50) is the dose coefficient (Sv Bq ) for inhalation of the radionuclide;
j
0,001 is a conversion factor from Sv to mSv.
[2] [3]
Values for e(50) shall be taken from ICRP 68 or from ICRP 53 and following addenda for
radiopharmaceuticals used as aerosols.
The likely intake can be calculated by the following Equation:
I  BT C (2)
WORK m
where
3 -1
B is the worker ventilation rate (1,2 m .h );
T is the time spent by the worker in the radioactive atmosphere (h) and;
work
-3
C is the airborne concentration of the radionuclide (Bq.m ).
m
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ISO/DIS 16637
If no other reliable information is available or may be obtained from a limited monitoring on a sample of
worker, the likely annual dose can be estimated according to the criteria suggested by IAEA Safety Guide RS-
[4]
G-
...

NORME ISO
INTERNATIONALE 16637
Première édition
2016-02-15
Radioprotection — Surveillance et
dosimétrie interne des travailleurs
exposés lors des utilisations médicales
des radioéléments en sources non
scellées
Radiological protection — Monitoring and internal dosimetry for
staff members exposed to medical radionuclides as unsealed sources
Numéro de référence
ISO 16637:2016(F)
©
ISO 2016

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ISO 16637:2016(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2016, Publié en Suisse
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
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CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
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ISO 16637:2016(F)

Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 2
3 Termes et définitions . 2
4 Symboles et abréviations . 6
5 Objectif et nécessité des programmes de surveillance en médecine nucléaire
diagnostique et thérapeutique . 6
5.1 Généralités . 6
5.2 Évaluation du niveau des expositions potentielles . 6
5.3 Programmes de surveillance . . 7
5.3.1 Généralités . 7
5.3.2 Programmes de surveillance de contrôle . 8
5.3.3 Programmes de surveillance de routine . 8
5.3.4 Programmes de surveillance de triage . 9
5.3.5 Programmes de surveillance de chantier . 9
5.3.6 Programmes de surveillance spéciale . 9
5.3.7 Mise en œuvre d’un programme de surveillance . 9
6 Radionucléides courants.10
7 Niveaux de référence .11
8 Programmes de surveillance de routine .12
8.1 Aspects généraux .12
8.2 Surveillance individuelle .13
8.3 Méthodes et intervalles de surveillance .13
9 Programmes de surveillance de triage .14
10 Programmes de surveillance spéciale.15
10.1 Aspects généraux .15
10.2 Surveillance aux postes de travail .15
10.3 Surveillance individuelle .15
11 Programmes de surveillance de contrôle .16
11.1 Aspects généraux .16
11.2 Surveillance aux postes de travail .16
11.3 Surveillance individuelle .17
12 Techniques de mesure et critères de performance .17
12.1 Généralités .17
12.2 Mesurages réalisés dans un laboratoire spécialisé d’anthroporadiométrie ou
de radiotoxicologie .18
12.2.1 In vitro.18
12.2.2 In vivo .18
12.2.3 Assurance qualité et contrôle qualité pour les laboratoires
d’anthroporadiométrie et de radiotoxicologie .18
12.3 Mesurages réalisés dans un service de médecine nucléaire .18
13 Procédure d’évaluation des expositions .19
13.1 Interprétation dosimétrique des données de la surveillance individuelle .19
13.1.1 Généralités .19
13.1.2 Estimation dosimétrique lors d’une surveillance de routine .19
13.1.3 Estimation dosimétrique lors d’une surveillance spéciale . .19
13.2 Outils logiciels .24
13.3 Incertitudes .24
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ISO 16637:2016(F)

13.4 Assurance de la qualité du processus d’estimation .24
14 Compte-rendu et documentation .25
14.1 Compte-rendu des résultats de mesurages in vitro .25
14.2 Compte-rendu des résultats de mesurages in vivo .25
14.3 Documentation de l’estimation dosimétrique .26
Annexe A (informative) «Facteur de décision» du Guide de Sûreté RS-G-1.2 de l’AIEA .27
Bibliographie .29
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ISO 16637:2016(F)

Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www.
iso.org/directives).
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion
de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC) voir le lien suivant: www.iso.org/iso/fr/foreword.html.
Le comité chargé de l’élaboration du présent document est l’ISO/TC 85, Énergie nucléaire, technologies
nucléaires, et radioprotection, sous-comité SC 2, Radioprotection.
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ISO 16637:2016(F)

Introduction
Dans le cadre de leurs activités professionnelles, les travailleurs peuvent être exposés à des produits
radioactifs qui, selon certaines circonstances, peuvent être incorporés. La protection des travailleurs
contre les risques d’incorporation des radionucléides exige une surveillance des incorporations
potentielles et/ou la quantification des incorporations et des expositions. Les doses résultant de
l’exposition aux rayonnements ionisants provenant d’une contamination interne par des substances
radioactives ne peuvent pas être mesurées directement. Le choix des examens et des programmes
de radioprotection dans ce domaine demande de prendre des décisions concernant les méthodes, les
techniques utilisées, la fréquence des mesurages d’activité, etc. et les estimations dosimétriques. Les
critères permettant d’évaluer la nécessité d’un programme de surveillance et de choisir des méthodes
et une fréquence de surveillance dépendent en général de la législation, de l’objectif du programme de
radioprotection, de l’exposition potentielle aux rayonnements ionisants et des caractéristiques des
matériaux manipulés.
Dans ce contexte, des normes ISO fixant les exigences relatives aux programmes de surveillance
(ISO 20553), les exigences relatives aux laboratoires (ISO 28218) et à l’estimation de la dose interne
(ISO 27048) ont été élaborées. Ces normes peuvent s’appliquer directement à de nombreux postes de
travail où une contamination interne est susceptible de survenir. Afin de les appliquer au personnel
impliqué dans les utilisations diagnostiques ou thérapeutiques des radionucléides en médecine, la
courte période effective des radionucléides couramment utilisés à ces fins et l’éloignement entre d’une
part les services de médecine nucléaire et d’autre part les installations de comptage in vivo ou les
laboratoires de radiotoxicologie, doivent être pris en compte. En conséquence, de nombreux pays ont
demandé à disposer de directives sur l’application des trois Normes internationales mentionnées ci-
dessus au personnel des services de médecine nucléaire.
La présente Norme internationale définit des critères permettant de déterminer si une surveillance
de l’incorporation est requise pour le personnel exposé aux radionucléides médicaux en sources
non scellées. Elle fixe également les exigences relatives à la conception des programmes de cette
surveillance, aux estimations de dose associées et aux exigences relatives aux laboratoires. Les
recommandations des instances internationales et les expériences internationales pour l’application
pratique de ces recommandations dans les programmes de radioprotection ont été prises en compte
dans le développement de la présente Norme internationale. Son application facilite les échanges des
données entre les autorités, les instituts de contrôle et les employeurs. La présente Norme internationale
ne dispense pas les utilisateurs de respecter les exigences légales.
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NORME INTERNATIONALE ISO 16637:2016(F)
Radioprotection — Surveillance et dosimétrie interne des
travailleurs exposés lors des utilisations médicales des
radioéléments en sources non scellées
1 Domaine d’application
La présente Norme internationale décrit les exigences minimales permettant d’établir des programmes
de surveillance professionnelle des travailleurs exposés à un risque de contamination interne par
inhalation lors de l’utilisation, à des fins diagnostiques ou thérapeutiques, de radionucléides en sources
non scellées dans les services de médecine nucléaire. Elle établit des principes pour l’élaboration
d’objectifs et d’exigences compatibles avec les programmes de surveillance et, le cas échéant,
l’estimation de la dose. Elle présente les procédures et les hypothèses considérées pour l’analyse du
risque, pour la mise en place des programmes de surveillance et pour l’interprétation normalisée des
données de surveillance.
La présente Norme internationale traite des points suivants:
a) objectifs de la surveillance et des programmes de surveillance;
b) description des différentes catégories de programmes de surveillance;
c) critères quantitatifs pour la conduite des programmes de surveillance;
d) méthodes valables pour la surveillance et leurs critères de sélection;
e) informations à collecter pour l’élaboration d’un programme de surveillance;
f) exigences générales pour les programmes de surveillance (par exemple? limites de détection,
incertitudes tolérées);
g) fréquence des mesurages;
h) procédures d’estimation dosimétrique fondées sur des niveaux de référence pour les programmes
de surveillance de routine et post-incidentelle;
i) hypothèses pour le choix des paramètres influençant l’estimation dosimétrique;
j) critères pour déterminer si les résultats de la surveillance individuelle sont significatifs;
k) interprétation des résultats de la surveillance aux postes de travail;
l) incertitudes liées aux estimations de la dose et à l’interprétation des données de mesurage in vivo
et d’analyse in vitro;
m) compte-rendu/documentation;
n) assurance de la qualité.
La présente Norme internationale ne traite pas des points suivants:
— surveillance et dosimétrie interne pour les travailleurs exposés lors des utilisations en laboratoire
de radionucléides, par exemple lors des dosages radio-immunologiques;
— surveillance et dosimétrie interne pour les travailleurs impliqués dans l’exploitation, la maintenance
et l’entretien des cyclotrons TEP;
— descriptions détaillées des méthodes et techniques de mesurage;
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ISO 16637:2016(F)

— dosimétrie dans les cas litigieux;
— modélisation pour l’amélioration de la dosimétrie interne;
— influence potentielle d’un traitement médical de la contamination interne;
— investigation des causes ou des conséquences d’une exposition;
— dosimétrie pour les expositions par ingestion et par plaies contaminées.
2 Références normatives
Les documents suivants, dans leur intégralité ou non, sont des références normatives indispensables à
l’application du présent document. Pour les références datées, seule l’édition citée s’applique. Pour les
références non datées, la dernière édition du document de référence s’applique (y compris les éventuels
amendements).
ISO 20553, Radioprotection — Surveillance professionnelle des travailleurs exposés à un risque de
contamination interne par des matériaux radioactifs
ISO 27048:2011, Radioprotection — Estimation de la dose interne dans le cadre de la surveillance des
travailleurs en cas d’exposition aux rayonnements
ISO 28218, Radioprotection — Critères de performance pour l’analyse radiotoxicologique
Guide ISO/IEC 99, Vocabulaire international de métrologie — Concepts fondamentaux et généraux et
termes associés (VIM)
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions donnés dans le Guide ISO/IEC 99,
l’ISO 20553, l’ISO 28218 et l’ISO 27048 ainsi que les suivants s’appliquent.
3.1
absorption
transfert de composés dans le sang, quel qu’en soit le mécanisme, qui s’applique généralement à la
dissociation des particules et à l’incorporation dans le sang des substances solubles et des composés
dissociés des particules
3.2
absorption de type F
telle que définie par la CIPR, absorption (3.1) des composés déposés présentant un taux de transfert
rapide (en anglais, fast) de l’appareil respiratoire vers les fluides corporels
3.3
absorption de type M
telle que définie par la CIPR, absorption (3.1) des composés déposés présentant un taux de transfert
intermédiaire (en anglais, moderate) de l’appareil respiratoire vers les fluides corporels
3.4
activité
nombre de désintégrations nucléaires par unité de temps
Note 1 à l’article: L’activité est exprimée en becquerels (Bq), soit en nombre de désintégrations par seconde.
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3.5
diamètre aérodynamique médian en activité
DAMA
valeur du diamètre aérodynamique telle que 50 % de l’activité dans l’air d’un aérosol défini sont associés
à des particules plus petites que le DAMA, et que 50 % de l’activité (3.4) sont associés à des particules
plus grosses que le DAMA
Note 1 à l’article: Le diamètre aérodynamique d’une particule dans l’air est le diamètre correspondant à une
sphère de densité unitaire qui devrait posséder la même vélocité dans l’air que la particule étudiée.
3.6
contamination
activité (3.4) des radionucléides présents sur les surfaces, dans les solides, dans les liquides ou dans les
gaz (y compris le corps humain), dont la présence est inattendue ou indésirable
3.7
seuil de décision
valeur invariable du mesurande qui, lorsqu’elle est dépassée par la valeur du résultat d’un mesurage
réel du mesurande quantifiant un effet physique, permet de décider que l’effet physique est présent
3.8
limite de détection
plus petite valeur vraie du mesurande qu’il est possible de détecter par la méthode de mesurage
3.9
dose annuelle
dose efficace engagée (3.11) résultant de toutes les incorporations (3.14) survenues durant une année
calendaire
Note 1 à l’article: Le terme «dose annuelle» n’est pas utilisé pour représenter la dose reçue en une année résultant
de l’ensemble des incorporations antérieures.
3.10
dose équivalente engagée
somme des produits des doses totales absorbées par un organe ou un tissu, provenant des différents
types de rayonnements et intégrée sur la période d’engagement succédant à l’incorporation (3.14) d’un
radionucléide, par les facteurs de pondération tissulaire appropriés
3.11
dose efficace engagée
somme des produits des doses équivalentes reçues par un organe ou un tissu et des facteurs de
pondération tissulaire appropriés
Note 1 à l’article: Dans le cadre de la présente Norme internationale, la période d’engagement [temps d’intégration
après l’incorporation (3.14)] retenue est de 50 ans.
3.12
fonction d’excrétion
fonction décrivant la fraction d’une incorporation (3.14) excrétée par jour après un temps donné après
incorporation
3.13
événement = incident
toute circonstance inattendue, incluant une erreur de manipulation, un défaut d’équipement ou autre
incident, qui entraînerait des conséquences réelles ou potentielles qui peuvent être non négligeables du
point de vue de la radioprotection ou de la sûreté
3.14
incorporation
activité (3.4) d’un radionucléide ayant pénétré dans le corps à un moment donné ou résultant d’un
événement donné
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3.15
examens in vitro
mesurages indirects
examens, y compris le mesurage de la radioactivité, effectués sur des échantillons biologiques issus
d’une personne
Note 1 à l’article: Ils comprennent des échantillons d’urine, de fèces et de mucus nasal; dans le cadre des
programmes de surveillance spéciale (3.21), d’autres échantillons peuvent être prélevés, comme par exemple le
sang et les cheveux.
3.16
mesurages in vivo
mesurages directs
mesurages de la radioactivité retenue dans un corps humain, effectué en utilisant des détecteurs pour
mesurer les rayonnements émis
Note 1 à l’article: Normalement, les dispositifs mesurent l’activité dans tout le corps ou une partie du corps (par
exemple poumons, thyroïde).
3.17
surveillance
campagnes de mesurages ayant pour objet l’évaluation ou le contrôle de l’exposition à des composés
radioactifs et l’interprétation des résultats
Note 1 à l’article: La présente Norme internationale distingue cinq catégories différentes de programmes de
surveillance, à savoir programmes de surveillance de routine (3.18), programmes de surveillance de chantier
(3.19), programmes de surveillance de triage (3.20), programmes de surveillance spéciale (3.21) et programmes de
surveillance de contrôle (3.22).
Note 2 à l’article: La présente Norme internationale distingue deux types différents de surveillance, à savoir la
surveillance individuelle (3.23) et la surveillance aux postes de travail (3.24).
3.18
programme de surveillance de routine
programme de surveillance associé à des opérations continues et visant à démontrer que les conditions
de travail, y compris les niveaux de doses individuelles, restent satisfaisantes et en accord avec les
exigences réglementaires
3.19
programme de surveillance particulière (de chantiers)
programme de surveillance s’appliquant à une opération spécifique et permettant d’obtenir des
données soit sur une opération spécifique d’une durée limitée, soit à la suite de modifications majeures
appliquées aux installations ou aux procédures, ou mis en place pour confirmer que le programme de
surveillance de routine (3.18) est adéquat
3.20
programme de surveillance de triage
programme de surveillance consistant à réaliser des mesurages fréquents dans les services de
médecine nucléaire qui ne permettent pas d’évaluer une dose reçue, mais simplement de vérifier qu’un
seuil donné d’incorporation (3.14) potentielle n’a pas été franchi
3.21
programme de surveillance spéciale
programme de surveillance mis en place pour quantifier des expositions significatives suite à des
événements anormaux réels ou suspectés
3.22
programme de surveillance de contrôle
programme de surveillance mis en place pour confirmer des hypothèses sur les conditions de travail,
par exemple que des incorporations (3.14) significatives ne se sont pas produites
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3.23
surveillance individuelle
surveillance effectuée par le port d’un appareil individuel de mesurage ou par le mesurage des quantités
de composés radioactifs retenues sur ou dans le corps de chaque travailleur ou par le mesurage des
composés radioactifs excrétés par chaque travailleur
3.24
surveillance aux postes de travail
surveillance effectuée à partir des mesurages effectués dans l’environnement de travail
3.25
intervalle de surveillance
période entre deux dates successives de mesurage
3.26
assurance de la qualité
toutes les actions planifiées et systématiques nécessaires pour attester qu’un processus, un mesurage
ou un service satisfait aux exigences de qualité, par exemple, celles spécifiées dans une autorisation
3.27
contrôle de la qualité
partie de l’assurance de la qualité (3.26) destinée à vérifier que les systèmes et les composants
correspondent à des exigences qualité prédéterminées
3.28
management de la qualité
toutes les activités de la fonction globale de management qui déterminent la politique, les objectifs et
les responsabilités, et les mettent en application à l’aide de la planification de la qualité, du contrôle de
la qualité (3.27), de l’assurance de la qualité (3.26) et de l’amélioration de la qualité dans le cadre du
système qualité
3.29
niveau de référence
niveau d’investigation (3.30) ou niveau d’enregistrement (3.29)
3.30
niveau d’enregistrement
niveau de dose, d’exposition, ou d’incorporation (3.14), spécifié par l’employeur ou par l’organisme de
réglementation, à partir duquel les valeurs de dose reçues par les travailleurs doivent être consignées
dans leur dossier individuel
3.31
niveau d’investigation
niveau de dose, d’exposition ou d’incorporation (3.14) à partir duquel une investigation doit être menée
afin de réduire l’incertitude associée à l’estimation de la dose
3.32
fonction de rétention
fonction décrivant la fraction de l’incorporation (3.14) retenue dans l’organisme ou dans un tissu, un
organe cible ou une région corporelle, après un temps donné suivant l’incorporation
3.33
facteur de dispersion
écart-type géométrique de la distribution log-normale des mesurages sur des échantillons biologiques
3.34
date de la mesure
date de début de l’examen
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ISO 16637:2016(F)

4 Symboles et abréviations
A Valeur de la limite de détection de l’activité (en becquerels) pour des mesurages de routine
DL
DAMA Diamètre aérodynamique médian en activité
3 −1
B Débit respiratoire d’un trav
...