ISO 16638-1:2015

Radiological protection — Monitoring and internal dosimetry for specific materials — Part 1: Inhalation of uranium compounds

ISO 16638-1:2015 specifies the minimum requirements for the design of professional programmes to monitor workers exposed to uranium compounds. It establishes principles for the development of compatible goals and requirements for monitoring programmes and dose assessment for workers occupationally exposed to internal contamination. It establishes procedures and assumptions for risk analysis, monitoring programmes and the standardised interpretation of monitoring data in order to achieve acceptable levels of reliability for uranium and its compounds. It sets limits for the applicability of the procedures in respect to dose levels above which more sophisticated methods have to be applied. Uranium is both radiologically and chemically toxic. Hence, the scientific bases of current occupational exposure standards are reviewed in addition to radiation exposure limits. This International Standard addresses those circumstances when exposure could be constrained by either radiological or chemical toxicity concerns. ISO 16638-1:2015 addresses, for uranium and its compounds, 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 monitoring results; k) interpretation of workplace monitoring results; l) uncertainties arising from dose assessment and interpretation of bioassays data; m) reporting/documentation; n) quality assurance; o) record keeping requirements. It is not applicable to the following items: a) monitoring of exposure due to uranium progeny, including radon; b) detailed descriptions of measuring methods and techniques for uranium; c) dosimetry for litigation cases; d) modelling for the improvement of internal dosimetry; e) potential influence of counter-measures (e.g. administration of chelating agents); f) investigation of the causes or implications of an exposure; g) dosimetry for ingestion exposures and for contaminated wounds.

Radioprotection — Contrôle et dosimétrie interne des éléments spécifiques — Partie 1: Inhalation de composés d'uranium

L'ISO 16638-1:2015 décrit les exigences minimales permettant d'établir des programmes de surveillance professionnelle des travailleurs exposés aux composés de l'uranium. Elle établit les principes pour la mise en ?uvre des objectifs et des exigences des programmes de surveillance et de l'estimation dosimétrique des travailleurs exposés, dans cadre de leur travail, à une contamination interne. Elle établit des procédures et des hypothèses relatives à l'analyse des risques, aux programmes de surveillance et à l'interprétation normalisée des résultats de cette surveillance, afin d'atteindre des niveaux acceptables de fiabilité pour l'uranium et ses composés. Elle fixe des limites pour l'applicabilité des procédures concernant les niveaux de dose au-delà desquels des méthodes plus sophistiquées doivent être appliquées. L'uranium présente une toxicité à la fois radiologique et chimique. De ce fait, pour une exposition professionnelle, les bases scientifiques des conditions actuelles d'exposition au risque chimique sont revues au vu des limites d'exposition aux rayonnements ionisants. L'ISO 16638-1:2015 traite des circonstances dans lesquelles l'exposition peut être assujettie aux problèmes liés à la toxicité radiologique ou chimique. L'ISO 16638-1:2015 aborde, pour l'uranium et ses composés, les points suivants: a) les objectifs de la surveillance et les programmes de surveillance; b) la description des différentes catégories de programmes de surveillance; c) les critères quantitatifs pour la conduite des programmes de surveillance; d) les méthodes valables pour la surveillance et leurs critères de sélection; e) les informations à collecter pour l'élaboration d'un programme de surveillance; f) les exigences générales pour les programmes de surveillance (par exemple limites de détection, incertitudes tolérées); g) les fréquences des mesurages; h) les procédures d'estimation dosimétrique basées sur les niveaux de référence utilisés pour les programmes de surveillance de routine et spéciale; i) les hypothèses concernant la sélection des valeurs des paramètres critiques de dose; j) les critères pour la détermination de l'importance des résultats de la surveillance; k) l'interprétation des résultats de la surveillance aux postes de travail; l) les incertitudes liées à l'estimation dosimétrique et l'interprétation des résultats sur échantillons biologiques; m) la transmission et la documentation; n) l'assurance de la qualité; o) les exigences en matière de conservation des enregistrements. Le domaine d'application de la présente Norme internationale n'inclut pas les éléments suivants: a) la surveillance de l'exposition aux descendants de l'uranium, y compris le radon; b) les descriptions détaillées des méthodes et des techniques de mesurage concernant l'uranium; c) la dosimétrie des cas litigieux; d) la modélisation pour l'amélioration de la dosimétrie interne; e) l'influence potentielle de l'action des agents décorporants (par exemple, administration d'agents complexants); f) l'investigation des causes et des conséquences d'une exposition; g) la dosimétrie pour les expositions par ingestion et par blessures contaminées.

General Information

• Status: Published
• Publication Date: 08-Dec-2015
• ICS: 17.240 - Radiation measurements
• 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 16638-1
First edition
2015-12-15
Radiological protection —
Monitoring and internal dosimetry
for specific materials —
Part 1:
Inhalation of uranium compounds
Radioprotection — Contrôle et dosimétrie interne des éléments
spécifiques —
Partie 1: Inhalation de composés d’uranium
Reference number
ISO 16638-1:2015(E)
©
ISO 2015

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ISO 16638-1:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2015 – All rights reserved

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ISO 16638-1:2015(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 6
4.1 Symbols . 6
4.2 Abbreviated terms . 7
5 Purpose and need for monitoring programmes . 7
6 General aspects .10
6.1 Radiological aspects .10
6.2 Chemical toxicity .11
7 Reference levels for uranium .12
7.1 Radiological aspects .12
7.2 Chemical toxicity .15
7.2.1 General.15
7.2.2 Exposure limits .15
7.3 Application of reference levels .16
8 Routine monitoring programmes .16
8.1 General .16
8.2 Workplace monitoring . .16
8.3 Individual monitoring .17
8.3.1 General.17
8.3.2 Dosimetric and radiation .17
8.3.3 Chemical hazard .18
8.4 Methods and monitoring intervals .18
8.4.1 General.18
8.4.2 Time intervals for toxicological risk.18
8.4.3 Time intervals for radiotoxicological risk .18
8.4.4 Principles and assumptions .19
9 Special monitoring programmes .20
9.1 Workplace monitoring . .20
9.2 Individual monitoring .20
9.2.1 Recommended monitoring for toxicological risk .20
9.2.2 Recommended monitoring and period for radiotoxicological risk .20
10 Task-related monitoring programmes .21
10.1 Workplace monitoring . .21
10.2 Individual monitoring .21
11 Performance criteria for laboratories .22
11.1 General .22
11.2 Critical values .22
11.3 Reference values .23
11.4 Performance criteria for workplace monitoring .23
12 Quality assurance and quality control for bioassay laboratories .24
13 Procedure for the assessment of exposures .24
13.1 General .24
13.2 Assessment of workplace monitoring data .25
13.3 Assessment of individual monitoring data .25
13.4 Properties of a software tool .25
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ISO 16638-1:2015(E)

13.5 Uncertainties .26
13.6 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 .28
14.3 Documentation of the dose assessment .28
Annex A (informative) Nuclear data of U-238 and U-235 decay .30
Annex B (informative) Default classification of uranium compounds .31
Annex C (informative) Measurement techniques for uranium .32
Annex D (informative) Committed effective dose per unit intake for uranium compounds .36
Annex E (informative) Estimation of uncertainties for internal dose assessments .37
Bibliography .41
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ISO 16638-1:2015(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 16638-1:2015(E)

Introduction
In the course of employment, individuals may work with radioactive materials that, under certain
circumstances, could be taken into the body. Protecting workers against the risks of incorporated
radionuclides requires monitoring potential intakes and/or quantifying actual intakes and exposures.
The doses resulting from internal radiation exposure arising from contamination by radioactive
substances cannot be measured directly. Decisions have to be made regarding which methods,
techniques, frequencies, etc., to select in order to measure and assess these doses. The criteria for
determining the design of a monitoring programme, i.e. its requirements, methods and schedule, usually
depends on legislation, the purpose of the overall radiation protection programme, the probabilities of
potential radionuclide intakes and the characteristics of the materials handled.
For these reasons, three International Standards addressing monitoring programmes (ISO 20553:2006),
laboratory requirements (ISO 28218:2010) and dose assessments (ISO 27048:2011) have been
developed and can be applied in a straightforward manner to many radionuclides. However, for a
number of specific materials, the practical application of these International Standards is complex and
further guidance may be required, e.g. for accreditation purposes.
This International Standard has been developed to address the specific issue of monitoring and internal
dosimetry for inhalation of uranium compounds, which reflects
— the growing interest in nuclear energy production and the associated increase in uranium mining
and fuel production,
— the large variation of isotopic compositions of the uranium compounds that may be encountered in
the workplace, and
— the importance of taking into account both the chemical and the radiological risks arising from
exposures to uranium.
It contributes to harmonizing the practices in the monitoring of occupationally exposed persons while
remaining complementary to ISO 20553:2006, ISO 28218:2010 and ISO 27048:2011.
This International Standard describes the need for a monitoring and internal dosimetry programme
for the different compounds of uranium and offers guidance on its design. Its development has taken
into account recommendations from international expert bodies and persons with international
experience of the practical application of its recommendations in radiological protection programmes.
Its application facilitates the exchanges of information between authorities, supervisory institutions
and employers.
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INTERNATIONAL STANDARD ISO 16638-1:2015(E)
Radiological protection — Monitoring and internal
dosimetry for specific materials —
Part 1:
Inhalation of uranium compounds
1 Scope
This International Standard specifies the minimum requirements for the design of professional
programmes to monitor workers exposed to uranium compounds. It establishes principles for the
development of compatible goals and requirements for monitoring programmes and dose assessment for
workers occupationally exposed to internal contamination. It establishes procedures and assumptions
for risk analysis, monitoring programmes and the standardised interpretation of monitoring data in
order to achieve acceptable levels of reliability for uranium and its compounds. It sets limits for the
applicability of the procedures in respect to dose levels above which more sophisticated methods have
to be applied.
Uranium is both radiologically and chemically toxic. Hence, the scientific bases of current occupational
exposure standards are reviewed in addition to radiation exposure limits. This International Standard
addresses those circumstances when exposure could be constrained by either radiological or chemical
toxicity concerns.
This International Standard addresses, for uranium and its compounds, 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 monitoring results;
k) interpretation of workplace monitoring results;
l) uncertainties arising from dose assessment and interpretation of bioassays data;
m) reporting/documentation;
n) quality assurance;
o) record keeping requirements.
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ISO 16638-1:2015(E)

It is not applicable to the following items:
a) monitoring of exposure due to uranium progeny, including radon;
b) detailed descriptions of measuring methods and techniques for uranium;
c) dosimetry for litigation cases;
d) modelling for the improvement of internal dosimetry;
e) potential influence of counter-measures (e.g. administration of chelating agents);
f) investigation of the causes or implications of an exposure;
g) 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/IEC Guide 98-3, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in
measurement (GUM:1995)
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General
principles and definitions
ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method
for the determination of repeatability and reproducibility of a standard measurement method
ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate
measures of the precision of a standard measurement method
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
ISO 15189:2012, Medical laboratories — Requirements for quality and competence
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99, ISO 5725-1,
ISO 5725-2, ISO 5725-3 and the following apply.
3.1
absorption
movement of material into blood regardless of mechanism, which generally applies to the dissociation
of particles and the uptake into blood of soluble substances and material dissociated from particles
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ISO 16638-1:2015(E)

3.2
absorption Type F
deposited materials that have high (fast) rates of absorption into body fluids from the respiratory tract
[SOURCE: ICRP 66]
3.3
absorption Type M
deposited materials that have intermediate (moderate) rates of absorption into body fluids from the
respiratory tract
[SOURCE: ICRP 66]
3.4
absorption Type S
deposited materials that have low (slow) rates of absorption into body fluids from the respiratory tract
[SOURCE: ICRP 66]
3.5
activity
number of spontaneous nuclear disintegrations per unit time
Note 1 to entry: The activity is stated in becquerels (Bq), i.e. the number of disintegrations per second.
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
clearance
net effect of the biological processes by which radionuclides are removed from the body or from a
tissue, organ or region of the body
Note 1 to entry: The clearance rate is the rate at which this occurs.
3.8
contamination
radioactive substances on surfaces or within solids, liquids or gases (including the human body), where
its presence is unintended or undesirable, or the process giving rise to its presence in such places
3.9
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
3.10
decision threshold
fixed or a posteriori 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
3.11
detection limit
smallest true value of the measurand that is detectable by the measuring method
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ISO 16638-1:2015(E)

3.12
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.
3.13
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 integration time is 50 years following any intake.
3.14
equivalent dose
product of the absorbed dose and the radiation weighting factor for the specific radiation at this point
3.15
committed equivalent dose
time integral of the equivalent dose rate in a particular tissue or organ following intake of radioactive
material into the body of a reference person
Note 1 to entry: In the context of this International Standard, the integration time is 50 years following any intake.
3.16
excretion function
function describing the fraction of an intake excreted per day after a given time has elapsed since the
intake occurred
3.17
event
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
3.18
intake
act or process of taking radionuclides into the body by inhalation or ingestion or through the
skin
3.19
intake
activity of a radionuclide taken into the body in a given time period or as a result of a given
event
3.20
in vitro analyses
indirect measurements
analyses that include 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.
3.21
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.
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ISO 16638-1:2015(E)

3.22
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 four different categories of monitoring programmes,
namely confirmatory monitoring programme (3.23), routine monitoring programme (3.24), special monitoring
programme (3.25) and task-related monitoring programme (3.26), as well as two different types of monitoring,
namely individual monitoring (3.27) and workplace monitoring (3.28), which feature in each category.
3.23
confirmatory monitoring programme
monitoring programme carried out to confirm assumptions about working conditions
EXAMPLE Monitoring programme carried out to confirm that significant intakes have not occurred.
3.24
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 meet regulatory requirements
3.25
special monitoring programme
monitoring programme performed to quantify significant exposures following actual or suspected
abnormal events
3.26
task-related monitoring programme
monitoring programme related to a specific operation, or providing information on a specific operation
of limited duration, or following major modifications applied to the installations or operating
procedures, or confirming that the routine monitoring programme is suitable
3.27
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
3.28
workplace monitoring
monitoring using measurements made in the working environment
3.29
monitoring interval
period between two consecutive times of measurement
3.30
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
3.31
quality control
part of quality assurance intended to verify that systems and components correspond to
predetermined requirements
3.32
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
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ISO 16638-1:2015(E)

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
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
3.35
reference level
value of measured quantities above which some specified action or decision should be taken
3.36
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
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 16638-1
ISO/TC 85/SC 2 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2014-03-17 2014-06-17
Radiological protection - Monitoring and internal
dosimetry for specific materials —
Part 1:
Uranium
Radioprotection - Contrôle et dosimétrie interne des éléments spécifiques —
Partie 1: Uranium
ICS: 17.240
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 16638-1:2014(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 2014

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ISO/DIS 16638-1:2014(E)

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved

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ISO/DIS 16638-1
Contents Page
Foreword . iv
Introduction . v
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 . 7
6 General aspects . 10
7 Reference levels for uranium . 11
8 Routine monitoring programmes . 16
9 Special monitoring programmes . 19
10 Task-related monitoring programmes . 21
11 Performance criteria for laboratories . 22
12 Quality assurance and quality control for bioassay laboratories . 24
13 Procedure for the assessment of exposures . 25
14 Reporting and documentation . 27
Annex A (informative) Nuclear data of U-238 and U-235 decay . 30
Annex B (informative) Default classification of uranium compounds . 31
Annex C (informative) Measurements techniques for uranium . 32
Annex D (informative) Committed effective dose par unit intake for uranium compounds . 36
Annex E (informative) Estimation of uncertainties for internal dose assessments. 37
Bibliography . 41

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ISO/DIS 16638-1
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.
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.
ISO 16638-1 was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies, and
radiological protection, Subcommittee SC 2, Radiological protection.
This second/third/. edition cancels and replaces the first/second/. edition (), [clause(s) / subclause(s) /
table(s) / figure(s) / annex(es)] of which [has / have] been technically revised.
ISO 16638 consists of the following parts, under the general title Radiological protection — Monitoring and
internal dosimetry for specific materials:
 Part 1: Uranium
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ISO/DIS 16638-1
Introduction
In the course of employment, individuals may 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 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 addressing laboratory requirements (28218:2010), monitoring
programmes (20553:2006) and dose assessments (27048:2011) have been developed and can be applied in
a straightforward manner to many radionuclides. However, for a number of specific materials, their practical
application is complex and further guidance may be required, e.g for accreditation purposes. Such guidance
was requested by a number of countries during the consultation phase for these standards.
Monitoring and internal dosimetry for uranium and its compounds are addressed in this standard because of:
 the growing interest in nuclear energy production and the associated increase in uranium mining and fuel
production;
 the large variation of isotopic compositions of the compounds that may be encountered in the workplace;
and,
 the importance of taking into account both the chemical and the radiological risks arising from exposures
to uranium.
An ISO standard that addresses the specific issue of monitoring and internal dosimetry for uranium will
contribute to harmonising monitoring of occupationally exposed persons while remaining complementary to
the three earlier standards.
This International Standard offers guidance on the need for a monitoring and internal dosimetry programme
for the different compounds of uranium and how it should be designed. 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 16638-1

Radiological protection — Monitoring and internal dosimetry for
specific materials — Part 1: Uranium
1 Scope
This International Standard specifies the minimum requirements for the design of professional programmes to
monitor workers exposed to the different compounds of uranium and establishes principles for the
development of compatible goals and requirements for monitoring programmes and the dose assessment for
workers occupationally exposed to the risk of internal contamination. It presents procedures and assumptions
for the risk analysis, for the monitoring programmes and for the standardised interpretation of monitoring data,
in order to achieve acceptable levels of reliability for uranium and its compounds. Limits are set for the
applicability of the procedures in respect of the dose levels above which more sophisticated methods have to
be applied.
Uranium is both radiologically and chemically toxic. Hence the bases of current occupational exposure
standards are reviewed in addition to radiation exposure limits. This standard addresses those circumstances
when exposure could be constrained by either radiological or chemical toxicity concerns.
This International Standard addresses, for uranium and its compounds 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.
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ISO/DIS 16638-1
It is not applicable to the following:
a) the monitoring of exposure uranium progeny including radon;
b) detailed descriptions of measuring methods and techniques for uranium;
c) dosimetry for litigation cases;
d) modelling for the improvement of internal dosimetry;
e) the potential influence of counter-measures (e.g. administration of chelating agents);
f) the investigation of the causes or implications of an exposure;
g) 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/IEC Guide 98-3, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in
measurement (GUM:1995)
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms
(VIM)
ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General
principles and definitions
ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method
for the determination of repeatability and reproducibility of a standard measurement method
ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate
measures of the precision of a standard measurement method
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 5725-1,
ISO 5725-2, ISO 5725-3, and in Publications of ICRP and ICRU [6,7,8,9,10,11,12,13,14,15,16,17,18,19 and
20] and the following apply.
3.1
absorption
transfer of material from lungs to body fluids, characterised by its rate.
Note 1 to entry: In the absence of absorption rate values for specific radionuclide compounds, default values of type F,
M and S can be applied.
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ISO/DIS 16638-1
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 disintegrations per unit time
Note 1 to entry: The activity is stated in becquerels (Bq), i.e. the number of disintegrations per second.
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
clearance
net effect of the biological processes by which radionuclides are removed from the body or from a tissue,
organ or region of the body
Note 1 to entry: The clearance rate is the rate at which this occurs.
3.8
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
3.9
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
3.10
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
3.11
detection limit
smallest true value of the measurand which is detectable by the measuring method
3.12
annual dose
committed effective dose resulting from all intakes occurring during a calendar year
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ISO/DIS 16638-1
Note 1 to entry: The term “annual dose” is not used to represent the dose received in a year from all preceding
intakes.
3.13
committed effective dose = effective dose
sum of the products of the committed organ or tissue equivalent doses and the appropriate tissue weighting
factors where the integration time, in the context of this International Standard, is 50 years following any intake
3.14
equivalent dose
product of the absorbed dose and the quality factor for the specific radiation at this point
3.15
excretion function
fraction of an intake excreted per day after a given time has elapsed since the intake occurred
3.16
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
3.17
intake
activity of a radionuclide taken into the body in a given time period or as a result of a given event
3.18
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.
3.19
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.
3.20
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 four different categories of monitoring programmes, namely
confirmatory monitoring programme (3.21), routine monitoring programme (3.22), special monitoring programme
(3.23), and task-related monitoring programme (3.24), as well as two different types of monitoring, namely individual
monitoring (3.25) and workplace monitoring (3.26), which feature in each category.
3.21
confirmatory monitoring programme
monitoring programme carried out to confirm assumptions about working conditions
EXAMPLE Monitoring programme carried out to confirm that significant intakes have not occurred.
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ISO/DIS 16638-1
3.22
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
3.23
special monitoring programme
monitoring programme performed to quantify significant exposures following actual or suspected abnormal
events
3.24
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
3.25
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
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
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
3.32
reference level
investigation level or recording level


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ISO/DIS 16638-1
3.33
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
3.34
scattering factor
geometric standard deviation of the lognormal distribution of bioassay measurements
3.35
time of sampling
in vitro analysis time at which the biological sample (e.g. urine, faeces) was provided by the individual
concerned, that is the end time of the collection period.
3.36
time of measurement
in vivo analysis time at which the measurement begins
4 Symbols and abbreviated terms
4.1 Symbols
D committed effective dose due to annual intake (Sv) such that lower doses may be discounted for the
v
purpose of the monitoring programme (maximum value: 0,1 mSv)
E(50) committed effective dose within 50 years
e(50) dose coefficient: committed effective dose per unit intake
f gastro-intestinal uptake factor
1
I intake
m(t ) predicted value of the measured quantity at time, t, for unit intake (excretion or retention function at
i
time, t , for unit intake)
i
m (t ) predicted value of the quantity measured after a period of t days of a chronic unit intake per day
c i
(excretion or retention function at time, t , for chronic unit intake per day)
i
M measurement value at time, t
i i
M critical value
c
T duration of the monitoring interval (in days)
T/2 mid-time of the monitoring interval (in days)
E(t) Value of the excretion function at time t (day) after a unit intake;
R(t) Value of the retention function at time t (day) after a unit intake

A Detection limit
DL
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ISO/DIS 16638-1
4.2 Abbreviated terms
CRM Certified Reference Material (ISO 28218)
DAC Derived Air Concentration
DRL Derived Recording Level
DIL Derived Investigation Level
DU Uranium compound depleted in U-235 isotope by mass compared to natural uranium
HEU Uranium compound with high (92.8% by mass) enrichment in U-235 isotope
ICRP International Commission on Radiological Protection
IARC International Agency for Research on Cancer
LEU Uranium compound with low (3.5% by mass) enrichment in U-235 isotope
LOAEL Lowest Observed Adverse Effect Level
MRL Minimal Risk Level
NOAEL No Observed Adverse Effect Level
NU uranium compound with natural isotopic composition
PAS Personal Air Sampler
RPE Respiratory Protective Equipment
SAS Static Air Sampler
TRS Transfer Reference Standard (ISO 28218)
WHO World Health Organization
5 Purpose and need for monitoring programmes
234 235 238
Uranium compounds are considered as the mixture of major isotopes. U, U and U, but in certain cases,
233 232
U and U are also included. This standard retains four different isotopic compositions representing natural
(NU), depleted (DU) and low (LEU) and high (HEU) enriched uranium forms (see Table 1), representing the
typical uranium isotopic compositions encountered in the nuclear industry. Specific isotopic composition
should be used as far as they are available.
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ISO/DIS 16638-1
Table 1 — Typical Isotopic compositions by mass and total uranium alpha activities of Natural
Uranium (NU); Depleted Uranium (DU), Low Enriched Uranium (LEU) and High Enriched Uranium
(HEU)
U-238 U-235 U-234
Total
Alpha activity
Isotopic Total Isotopic Total Isotopic Total
alpha
ratio
composition alpha composition alpha composition alpha
activity
U-234/U-238
by mass activity by mass activity by mass activity
Bq/g
% % % % % %
NU 99,2745 48,26 0,72 2,25 0,0055 49,49 2,56E+04 1,03
DU 99,8000 83,39 0,2 1,07 0,0010 15,53 1,49E+04 0,186
LEU 96,471 14,78 3,5 3,45 0,02884 81,78 8,12E+04 5,53
HEU 6,06 0,039 92,8 3,89 0,79 95,64 1,91E+06 2452

In industry, uranium can be present in a variety of chemical forms, often in association with other
radionuclides. Usually, there is insufficient high quality data from inhalation by workers to derive the
absorption parameters for uranium and hence describe the biokinetics of the material which form the bases for
assessing radiological constraints or optimising monitoring procedures. However, the absorption data can be
obtained from animal studies designed specifically to calculate the material specific absorption parameters in
a range of industrial materials. For the purpose of recommending material-specific dose coefficients and
predicting the biokinetics of uranium in man, the absorption parameter values obtained from the animal
studies are combined with human deposition and particle transport data obtained from the ICRP Human
Respiratory Tract Model, and the ICRP systemic model for uranium [9]; deposition and particle transport
parameters are assumed by ICRP to be independent of the chemical form inhaled.
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 starts with an assessment to identify work situations in
which there is a risk of internal contamination of workers, and to quantify the likely intake of radioactive
material and the resulting committed effective dose received. Decisions about the need for monitoring and the
design of the monitoring programme should be made in the light of such a risk assessment.
Routine monitoring is performed to quantify normal exposures, i.e. where there is no evidence to indicate that
acute intakes have occurred, but where chronic exposures cannot be ruled out. The basis for routine
monitoring programmes is the assumption that working conditions and thus risks of intake remain reasonably
constant. The design of such a programme of regular measurements strongly depends on the level of the
annual dose the quantification of which is to be ensured. This level should be well below legally relevant limits;
its definition should take into account uncertainties, for example in activity measurement and dose
assessment. If this level is too high, intakes representing considerable fractions of dose limits could be
overlooked, whilst a low value may cause the expenditure of unnecessary efforts at low exposures.
Special monitoring is performed to quantify significant exposures following actual or suspected abnormal
events. Therefore in comparison to routine monitoring the time of intake is usually much better known and
additional information may be available, which helps to reduce the uncertainty of assessment. The purposes
of dose assessment in such cases include: to assist in decisions about countermeasures (e.g. decorporation
therapy), compliance with legal regulations and aiding decisions for the improvement of conditions at the
workplace. In most cases, special monitoring is performed individually. In cases where there is reason to
suspect that exposure limits could be exceeded, it may be appropriate to extend the measurements in order to
derive individual retention and excretion functions and biokinetic model parameters.
Confirmatory monitoring may be required to check the assumptions underlying the procedures previously
selected. It may consist of workplace or individual monitoring, e.g. as occasional measurements to investigate
the potential accumulation of activity in the body.
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ISO/DIS 16638-1
Task-related monitoring applies to a specific operation. The purpose and the dose criteria for carrying out
task-related monitoring are identical to those for routine monitoring.
Individual monitoring gives information needed to assess the exposure of a single worker by measuring
individual body activities, excretion rates or activity inhaled (using personal air samplers, see 8.1).
Workplace monitoring, which includes collective monitoring, provid
...

NORME ISO
INTERNATIONALE 16638-1
Première édition
2015-12-15
Radioprotection — Contrôle et
dosimétrie interne des éléments
spécifiques —
Partie 1:
Inhalation de composés d’uranium
Radiological protection — Monitoring and internal dosimetry for
specific materials —
Part 1: Inhalation of uranium compounds
Numéro de référence
ISO 16638-1:2015(F)
©
ISO 2015

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ISO 16638-1:2015(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2015, 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 16638-1:2015(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 termes abrégés . 7
4.1 Symboles . 7
4.2 Termes abrégés . 7
5  Objectif et nécessité des programmes de surveillance. 8
6  Aspects généraux .11
6.1 Aspects radiologiques .11
6.2 Toxicité chimique .12
7  Niveaux de référence pour l’uranium .13
7.1 Aspects radiologiques .13
7.2 Toxicité chimique .16
7.2.1 Généralités .16
7.2.2 Limites d’exposition .17
7.3 Application des niveaux de référence .18
8  Programmes de surveillance de routine .18
8.1 Généralités .18
8.2 Surveillance aux postes de travail .18
8.3 Surveillance individuelle .19
8.3.1 Généralités .19
8.3.2 Risque radiotoxicologique .19
8.3.3 Risque chimique .20
8.4 Méthodes et intervalles de surveillance .20
8.4.1 Généralités .20
8.4.2 Intervalles de surveillance pour le risque toxicologique .20
8.4.3 Intervalles de surveillance pour le risque radiotoxicologique .20
8.4.4 Principes et hypothèses .21
9  Programmes de surveillance spéciale.22
9.1 Surveillance aux postes de travail .22
9.2 Surveillance individuelle .22
9.2.1 Surveillance recommandée pour le risque toxicologique .22
9.2.2 Surveillance et période recommandées pour le risque radiotoxicologique .23
10  Programmes de surveillance de chantier .24
10.1 Surveillance aux postes de travail .24
10.2 Surveillance individuelle .24
11  Critères de performance pour les laboratoires de biologie médicale .24
11.1 Généralités .24
11.2 Valeurs critiques .24
11.3 Valeurs de référence .25
11.4 Critères de performance concernant la surveillance aux postes de travail .26
12  Assurance et contrôle de la qualité dans les laboratoires d’analyses médicales .26
13  Procédure d’évaluation des expositions .27
13.1 Généralités .27
13.2 Évaluation des données de la surveillance aux postes de travail .28
13.3 Évaluation des données de la surveillance individuelle .28
13.4 Propriétés d’un outil logiciel .28
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ISO 16638-1:2015(F)

13.5 Incertitudes .29
13.6 Assurance de la qualité du processus d’estimation .30
14  Transmission des résultats et documentation .30
14.1 Transmission des résultats relatifs aux analyses in vitro .30
14.2 Transmission des résultats relatifs aux examens in vivo .31
14.3 Documentation de l’estimation dosimétrique .31
Annexe A (informative) Données nucléaires des isotopes U-238 et U-235 .33
Annexe B (informative) Classification par défaut des composés de l’uranium .34
Annexe C (informative) Techniques de mesure de l’uranium .36
Annexe D (informative) Dose efficace engagée par unité d’incorporation pour les composés
de l’uranium .41
Annexe E (informative) Estimation des incertitudes relatives aux estimations
dosimétriques internes .42
Bibliographie .46
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ISO 16638-1:2015(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 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 16638-1:2015(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 réelles. Les doses, résultant
de l’exposition au rayonnement interne due à la contamination par des substances radioactives, ne
peuvent pas être mesurées directement. Des décisions doivent être prises concernant les méthodes, les
techniques, les fréquences, etc. à déterminer pour mesurer et estimer ces doses. Les critères permettant
d’élaborer un programme de surveillance, c’est-à-dire ses exigences, les méthodes employées et le
calendrier appliqué, dépendent en général de la législation, de l’objectif du programme global de
radioprotection, de l’exposition potentielle aux rayonnements ionisants et des caractéristiques
nucléaires des produits manipulés.
Ainsi, trois Normes internationales traitant des programmes de surveillance (ISO 20553:2006), des
exigences de laboratoires (ISO 28218:2010) et des estimations dosimétriques (ISO 27048:2011) ont été
élaborées afin de pouvoir être directement appliquées à de nombreux radionucléides. Toutefois, pour
un certain nombre de matériaux spécifiques, l’application pratique de ces Normes internationales est
complexe et des informations supplémentaires peuvent s’avérer nécessaires, par exemple à des fins
d’accréditation.
La présente Norme internationale a été élaborée pour traiter du domaine spécifique du contrôle et de la
dosimétrie interne associés à l’inhalation de composés d’uranium, qui reflète:
— l’intérêt croissant pour la production d’énergie nucléaire et l’augmentation accrue de l’extraction
d’uranium et de la production de combustibles;
— la grande variété des compositions isotopiques des composés de l’uranium susceptibles d’être
rencontrés sur le lieu de travail; et
— l’importance de la prise en compte des risques chimiques et radiologiques liés aux expositions à
l’uranium.
Elle contribue à l’harmonisation des pratiques de contrôle des personnes exposées dans le cadre de leur
travail, tout en restant complémentaire de l’ISO 20553:2006, de l’ISO 28218:2010 et de l’ISO 27048:2011.
La présente Norme internationale explicite la nécessité d’un programme de surveillance et de
dosimétrie interne pour les différents composés de l’uranium et fournit des lignes directrices pour sa
conception. Son développement a pris en compte les recommandations des instances internationales et
des personnes ayant une expérience internationale dans l’application pratique de ces recommandations
dans les programmes de radioprotection. Son application facilite les échanges de données entre les
autorités, les instituts de contrôle et les employeurs.
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NORME INTERNATIONALE ISO 16638-1:2015(F)
Radioprotection — Contrôle et dosimétrie interne des
éléments spécifiques —
Partie 1:
Inhalation de composés d’uranium
1 Domaine d’application
La présente Norme internationale décrit les exigences minimales permettant d’établir des programmes
de surveillance professionnelle des travailleurs exposés aux composés de l’uranium. Elle établit les
principes pour la mise en œuvre des objectifs et des exigences des programmes de surveillance et de
l’estimation dosimétrique des travailleurs exposés, dans cadre de leur travail, à une contamination
interne. Elle établit des procédures et des hypothèses relatives à l’analyse des risques, aux programmes
de surveillance et à l’interprétation normalisée des résultats de cette surveillance, afin d’atteindre des
niveaux acceptables de fiabilité pour l’uranium et ses composés. Elle fixe des limites pour l’applicabilité
des procédures concernant les niveaux de dose au-delà desquels des méthodes plus sophistiquées
doivent être appliquées.
L’uranium présente une toxicité à la fois radiologique et chimique. De ce fait, pour une exposition
professionnelle, les bases scientifiques des conditions actuelles d’exposition au risque chimique sont
revues au vu des limites d’exposition aux rayonnements ionisants. La présente Norme internationale
traite des circonstances dans lesquelles l’exposition peut être assujettie aux problèmes liés à la toxicité
radiologique ou chimique.
La présente Norme internationale aborde, pour l’uranium et ses composés, les points suivants:
a) les objectifs de la surveillance et les programmes de surveillance;
b) la description des différentes catégories de programmes de surveillance;
c) les critères quantitatifs pour la conduite des programmes de surveillance;
d) les méthodes valables pour la surveillance et leurs critères de sélection;
e) les informations à collecter pour l’élaboration d’un programme de surveillance;
f) les exigences générales pour les programmes de surveillance (par exemple limites de détection,
incertitudes tolérées);
g) les fréquences des mesurages;
h) les procédures d’estimation dosimétrique basées sur les niveaux de référence utilisés pour les
programmes de surveillance de routine et spéciale;
i) les hypothèses concernant la sélection des valeurs des paramètres critiques de dose;
j) les critères pour la détermination de l’importance des résultats de la surveillance;
k) l’interprétation des résultats de la surveillance aux postes de travail;
l) les incertitudes liées à l’estimation dosimétrique et l’interprétation des résultats sur échantillons
biologiques;
m) la transmission et la documentation;
n) l’assurance de la qualité;
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ISO 16638-1:2015(F)

o) les exigences en matière de conservation des enregistrements.
Le domaine d’application de la présente Norme internationale n’inclut pas les éléments suivants:
a) la surveillance de l’exposition aux descendants de l’uranium, y compris le radon;
b) les descriptions détaillées des méthodes et des techniques de mesurage concernant l’uranium;
c) la dosimétrie des cas litigieux;
d) la modélisation pour l’amélioration de la dosimétrie interne;
e) l’influence potentielle de l’action des agents décorporants (par exemple, administration d’agents
complexants);
f) l’investigation des causes et des conséquences d’une exposition;
g) la dosimétrie pour les expositions par ingestion et par blessures contaminées.
2 Références normatives
Les documents suivants, en tout ou partie, sont référencés de façon normative dans le présent document
et sont indispensables à son application. 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).
Guide ISO/IEC 98-3, Incertitude de mesure — Partie 3: Guide pour l’expression de l’incertitude de mesure
(GUM:1995)
Guide ISO/IEC 99, Vocabulaire international de métrologie — Concepts fondamentaux et généraux et
termes associés (VIM)
ISO 5725-1, Exactitude (justesse et fidélité) des résultats et méthodes de mesure — Partie 1: Principes
généraux et définitions
ISO 5725-2, Exactitude (justesse et fidélité) des résultats et méthodes de mesure — Partie 2: Méthode de
base pour la détermination de la répétabilité et de la reproductibilité d’une méthode de mesure normalisée
ISO 5725-3, Exactitude (justesse et fidélité) des résultats et méthodes de mesure — Partie 3: Mesures
intermédiaires de la fidélité d’une méthode de mesure normalisée
ISO 20553:2006, Radioprotection — Surveillance professionnelle des travailleurs exposés à un risque de
contamination interne par des matériaux radioactifs
ISO 28218:2010, Radioprotection — Critères de performance pour l’analyse radiotoxicologique
ISO 27048:2011, Radioprotection — Estimation de la dose interne dans le cadre de la surveillance des
travailleurs en cas d’exposition aux rayonnements
ISO 15189:2012, Laboratoires de biologie médicale — Exigences concernant la qualité et la compétence
3  Termes et définitions
Pour les besoins du présent document, les termes et définitions donnés dans le Guide ISO/IEC 99,
l’ISO 5725-1, l’ISO 5725-2, l’ISO 5725-3 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 de particules et à l’incorporation dans le sang de substances solubles et de composés
dissociés des particules
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ISO 16638-1:2015(F)

3.2
absorption de type F
absorption de composés qui ont un taux de transfert élevé (rapide) du site de dépôt de l’arbre
respiratoire vers les fluides du corps
[SOURCE: CIPR 66]
3.3
absorption de type M
absorption de composés qui ont un taux de transfert intermédiaire (modéré) du site de dépôt de l’arbre
respiratoire vers les fluides du corps
[SOURCE: CIPR 66]
3.4
absorption de type S
absorption de composés qui ont un taux de transfert faible (lent) du site de dépôt de l’arbre respiratoire
vers les fluides du corps
[SOURCE: CIPR 66]
3.5
activité
nombre de désintégrations nucléaires spontanées par unité de temps
Note 1 à l’article: L’activité est exprimée en becquerel (Bq), c’est-à-dire en nombre de désintégrations par seconde.
3.6
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 sont associés à des particules plus
grandes que le DAMA
Note 1 à l’article: Le diamètre aérodynamique d’une particule en suspension 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.
3.7
clairance
effet global des processus biologiques par lesquels les radionucléides sont éliminés du corps, d’un tissu,
d’un organe ou d’une région corporelle
Note 1 à l’article: Le taux de clairance représente la vitesse à laquelle ce phénomène se produit.
3.8
contamination
substances radioactives présentes sur les surfaces, dans les solides, dans les liquides ou dans les gaz (y
compris le corps humain), dont la présence est indésirable ou inattendue, ou processus aboutissant à
une telle présence
3.9
valeur critique
valeur maximale du résultat d’un seul mesurage d’un programme de surveillance pour lequel la dose
annuelle extrapolée correspondante n’excèdera pas, de manière certaine, un niveau de dose prédéfini
3.10
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
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ISO 16638-1:2015(F)

3.11
limite de détection
plus petite valeur vraie du mesurande qu’il est possible de détecter par la méthode de mesurage
3.12
dose annuelle
dose efficace engagée résultant de toutes les incorporations 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 à partir
de toutes les incorporations précédentes.
3.13
dose efficace engagée
somme des produits des doses équivalentes reçues par un organe ou un tissu par les facteurs de
pondération tissulaire appropriés
Note 1 à l’article: Dans le cadre de la présente Norme internationale, la durée d’intégration est de 50 ans après
incorporation.
3.14
dose équivalente
produit de la dose absorbée et du facteur de pondération pour le rayonnement particulier en ce point
3.15
dose équivalente engagée
intégrale par rapport au temps du débit de dose équivalente dans un tissu ou organe particulier après
incorporation de matières radioactives dans le corps d’une personne de référence
Note 1 à l’article: Dans le cadre de la présente Norme internationale, la durée d’intégration est de 50 ans après
incorporation.
3.16
fonction d’excrétion
fonction décrivant la fraction d’une incorporation qui est excrétée par jour après un temps donné après
incorporation
3.17
événement
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
3.18
incorporation
action ou processus de pénétration de radionucléides dans le corps par inhalation ou
ingestion ou à travers la peau
3.19
incorporation
activité d’un radionucléide ayant pénétré dans le corps à un moment donné ou résultant
d’un événement donné
3.20
analyses in vitro
mesurages indirects
analyses comprenant le mesurage de la radioactivité, effectuées sur des échantillons biologiques issus
d’une personne
Note 1 à l’article: Les échantillons biologiques correspondent à des échantillons urinaires, fécaux et de mucus
nasal. Dans le cadre des programmes de surveillance spéciale, d’autres échantillons peuvent être prélevés,
comme par exemple le sang et les cheveux.
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ISO 16638-1:2015(F)

3.21
examens in vivo
mesurages directs
mesurage de l’activité présente dans un corps humain, effectué en utilisant des détecteurs pour mesurer
les radiations émises
Note 1 à l’article: Normalement, les dispositifs mesurent l’activité de tout le corps ou d’une partie du corps (par
exemple poumons, thyroïde).
3.22
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 quatre catégories différentes de programmes de
surveillance, à savoir programme de surveillance de contrôle (3.23), programme de surveillance de routine (3.24),
programme de surveillance spéciale (3.25) et programme de surveillance de chantier (3.26), ainsi que deux types
différents de surveillance, à savoir surveillance individuelle (3.27) et surveillance aux postes de travail (3.28),
compris dans chaque catégorie.
3.23
programme de surveillance de contrôle
programme de surveillance mis en place pour confirmer des hypothèses sur les conditions de travail
EXEMPLE Programme de surveillance mis en place pour confirmer que des incorporations significatives ne
se sont pas produites.
3.24
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
3.25
programme de surveillance spéciale
programme de surveil
...