EN ISO 16638-1:2017
(Main)Radiological protection - Monitoring and internal dosimetry for specific materials - Part 1: Inhalation of uranium compounds (ISO 16638-1:2015)
Radiological protection - Monitoring and internal dosimetry for specific materials - Part 1: Inhalation of uranium compounds (ISO 16638-1:2015)
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.
Strahlenschutz - Überwachung und interne Dosimetrie für bestimmte Stoffe - Teil 1: Inhalation von Uranverbindungen (ISO 16638-1:2015)
Diese Internationale Norm legt Mindestanforderungen an die Gestaltung professioneller Programme zur Überwachung von Beschäftigten, die Uranverbindungen ausgesetzt sind, fest. Sie legt Grundsätze für die Entwicklung kompatibler Ziele und Anforderungen für Überwachungsprogramme und Dosisbeurteilung für Beschäftigte fest, die beruflich einer internen Kontamination ausgesetzt sind. Sie legt Verfahren und Annahmen für Risikoanalysen, Überwachungsprogramme und die standardisierte Interpretation von Überwachungsdaten fest, um ein akzeptables Zuverlässigkeitsniveau für Uran und dessen Verbindungen zu erreichen. Sie legt Grenzen für die Anwendbarkeit der Verfahren in Bezug auf Dosiswerte fest, oberhalb derer anspruchsvollere Methoden angewendet werden müssen.
Uran ist sowohl radiologisch als auch chemisch toxisch. Daher werden zusätzlich zu den Strahlenexpositionsgrenzwerten die wissenschaftlichen Grundlagen der aktuellen Standards für die berufsbedingte Exposition überprüft. Diese Internationale Norm behandelt die Umstände, unter denen die Exposition entweder hinsichtlich der radiologischen oder der chemischen Toxizität beschränkt werden könnte.
Diese Internationale Norm behandelt die folgenden Punkte in Bezug auf Uran und dessen Verbindungen:
a) Zwecke von Überwachung und Überwachungsprogrammen;
b) Beschreibung der verschiedenen Kategorien von Überwachungsprogrammen;
c) quantitative Kriterien für die Durchführung von Überwachungsprogrammen;
d) geeignete Verfahren zur Überwachung und Kriterien für deren Auswahl;
e) Informationen, die für die Gestaltung eines Überwachungsprogramms zu sammeln sind;
f) allgemeine Anforderungen an Überwachungsprogramme (z. B. Nachweisgrenzen, tolerierte Unsicherheiten);
g) Häufigkeiten von Messungen;
h) Verfahren zur Beurteilung der Dosis auf der Grundlage von Referenzwerten für Routine- und Sonderüberwachungsprogramme;
i) Annahmen für die Auswahl von dosiskritischen Parameterwerten;
j) Kriterien für die Bestimmung der Signifikanz von Überwachungsergebnissen;
k) Auswertung von Ergebnissen der Arbeitsplatzüberwachung;
l) Unsicherheiten, die sich aus der Beurteilung der Dosis und Auswertung von Biotest-Daten ergeben;
m) Berichterstattung/Dokumentation;
n) Qualitätssicherung;
o) Anforderungen an Aufzeichnungen.
Sie gilt nicht für die folgenden Punkte:
a) Überwachung der Exposition aufgrund von Tochternukliden von Uran, einschließlich Radon;
b) ausführliche Beschreibungen von Messmethoden und -techniken für Uran;
c) Dosimetrie für Rechtsstreitigkeiten;
d) Modellierung für die Verbesserung der internen Dosimetrie;
e) mögliche Einflüsse von Gegenmaßnahmen (z. B. Verabreichung von Komplexbildnern);
f) Untersuchung der Ursachen oder Auswirkungen einer Inkorporation;
g) Dosimetrie bei Inkorporation durch Ingestion und bei kontaminierten Wunden.
Radioprotection - Contrôle et dosimétrie interne des éléments spécifiques - Partie 1: Inhalation de composés d'uranium (ISO 16638-1:2015)
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.
Radiološka zaščita - Nadzorovanje in notranja dozimetrija za posebne materiale - 1. del: Inhalacija uranovih spojin (ISO 16638-1:2015)
Standard ISO 16638-1:2015 določa minimalne zahteve za načrtovanje profesionalnih programov za nadzor delavcev, ki so izpostavljeni uranovim spojinam. Določa načela za razvoj združljivih ciljev in zahtev za nadzorne programe in ocenjevanje odmerkov za delavce, ki so poklicno izpostavljeni notranji kontaminaciji. Določa postopke in predpostavke za analizo tveganja, nadzorne programe in standardizirano interpretacijo nadzornih podatkov za doseganje sprejemljivih ravni zanesljivosti za uran in uranove spojine. Določa omejitve ravni odmerkov za uporabo postopkov, nad katerimi je treba uporabiti bolj napredne metode.
Uran je radiološko in kemijsko toksičen. Zato so poleg omejitev izpostavljenosti sevanju revidirane tudi znanstvene osnove trenutnih standardov glede poklicne izpostavljenosti. Ta mednarodni standard obravnava okoliščine, ko je izpostavljenost lahko omejena zaradi radiološke ali kemijske toksičnosti.
Standard ISO 16638-1:2015 v zvezi z uranom in uranovimi spojinami obravnava:
a) namene nadzora in nadzornih programov;
b) opis različnih kategorij nadzornih programov;
c) kvantitativne kriterije za izvajanje nadzornih programov;
d) primerne metode za izvajanje nadzora in kriterije za izbiro metod;
e) informacije, ki jih je treba zbrati za načrtovanje nadzornega programa;
f) splošne zahteve za nadzorne programe (npr. meje zaznavanja, dovoljene negotovosti);
g) pogostosti meritev;
h) postopke za ocenjevanje odmerkov glede na referenčne ravni za rutinske in posebne nadzorne programe;
i) predpostavke za izbiro vrednosti parametrov, ki so ključni za odmerek;
j) merila za določanje pomembnosti rezultatov nadzora;
k) interpretacijo rezultatov nadzora na delovnem mestu;
l) negotovosti, ki izhajajo iz ocenjevanja odmerkov in interpretacije podatkov bioloških preizkusov;
m) poročanje/dokumentiranje;
n) zagotavljanje kakovosti;
o) zahteve za vodenje evidenc.
Ne uporablja se za:
a) nadzor izpostavljenosti potomcem urana, vključno z radonom;
b) podrobno opisovanje merilnih metod in tehnik za uran;
c) dozimetrijo za sporne primere;
d) modeliranje za izboljševanje notranje dozimetrije;
e) možne vplive protiukrepov (npr. dajanja kelatov);
f) raziskovanje razlogov ali vplivov izpostavljenosti;
g) dozimetrijo za izpostavljenosti ob zaužitju in kontaminirane rane.
General Information
- Status
- Published
- Publication Date
- 10-Oct-2017
- Withdrawal Date
- 29-Apr-2018
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 11-Oct-2017
- Due Date
- 05-May-2019
- Completion Date
- 11-Oct-2017
Overview
EN ISO 16638-1:2017 / ISO 16638-1:2015 - Radiological protection - Monitoring and internal dosimetry for specific materials - Part 1: Inhalation of uranium compounds.
Published by CEN as EN ISO 16638-1:2017, this standard specifies minimum requirements for designing professional monitoring programmes and internal dose assessment for workers occupationally exposed to inhaled uranium compounds. It addresses both the radiological and chemical toxicity aspects of uranium and sets procedural principles, performance expectations and limits of applicability for routine, special and task-related monitoring.
Key topics and requirements
The standard establishes practical and technical guidance on:
- Purposes and categories of monitoring programmes (routine, special, task-related).
- Quantitative criteria and reference levels to trigger monitoring and assessments.
- Selection of suitable monitoring methods, including workplace and individual monitoring (in vivo and in vitro bioassay).
- Information needs for programme design (workplace data, exposure scenarios).
- Performance criteria for bioassay and analytical laboratories (detection limits, critical values, reference values).
- Frequencies of measurements and sampling intervals for radiotoxicological and toxicological risk.
- Dose assessment procedures and standardised interpretation of monitoring data, including handling uncertainties.
- Reporting, documentation, record keeping, quality assurance and quality control for monitoring and dose assessment.
- Assumptions and selection of dose‑critical parameter values to ensure comparable and reliable assessments.
Important exclusions (not covered): monitoring of uranium progeny (including radon), detailed measuring techniques, ingestion or wound dosimetry, litigation-specific dosimetry, modelling development, countermeasure effects (e.g., chelation) and causal investigations.
Practical applications and users
This standard is intended for organizations and professionals responsible for workplace radiological protection and occupational health, including:
- Radiation Protection Officers (RPOs) and health & safety managers in nuclear, uranium-processing, mining, and research facilities.
- Industrial hygienists and occupational physicians assessing inhalation risks from uranium compounds.
- Bioassay and in vivo laboratories developing measurement programmes and QA/QC procedures.
- Regulators and compliance auditors defining monitoring requirements and evaluating programme adequacy.
- Dose assessment specialists and software developers implementing standardised assessment workflows.
Use cases include designing monitoring strategies, selecting analytical and bioassay methods, setting sampling intervals, performing standardised internal dose calculations, documenting results and maintaining compliant records.
Related standards
EN ISO 16638-1 complements other ISO/CEN standards on radiological protection and internal dosimetry. Users should consult applicable national regulations and other international guidance on workplace radiation protection to ensure full regulatory compliance.
Keywords: radiological protection, internal dosimetry, uranium compounds, monitoring programmes, bioassay, occupational exposure, dose assessment, EN ISO 16638-1.
Frequently Asked Questions
EN ISO 16638-1:2017 is a standard published by the European Committee for Standardization (CEN). Its full title is "Radiological protection - Monitoring and internal dosimetry for specific materials - Part 1: Inhalation of uranium compounds (ISO 16638-1:2015)". This standard covers: 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.
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.
EN ISO 16638-1:2017 is classified under the following ICS (International Classification for Standards) categories: 17.240 - Radiation measurements. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 16638-1:2017 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2017
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Radiological protection - Monitoring and internal dosimetry for specific materials - Part 1:
Inhalation of uranium compounds (ISO 16638-1:2015)
Radioprotection - Contrôle et dosimétrie interne des éléments spécifiques - Partie 1:
Inhalation de composés d'uranium (ISO 16638-1:2015)
Ta slovenski standard je istoveten z: EN ISO 16638-1:2017
ICS:
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 16638-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2017
EUROPÄISCHE NORM
ICS 17.240
English Version
Radiological protection - Monitoring and internal
dosimetry for specific materials - Part 1: Inhalation of
uranium compounds (ISO 16638-1:2015)
Radioprotection - Contrôle et dosimétrie interne des
éléments spécifiques - Partie 1: Inhalation de composés
d'uranium (ISO 16638-1:2015)
This European Standard was approved by CEN on 13 September 2017.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16638-1:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 16638-1:2015 has been prepared by Technical Committee ISO/TC 85 “Nuclear energy,
nuclear technologies, and radiological protection” of the International Organization for Standardization
(ISO) and has been taken over as EN ISO 16638-1:2017 by Technical Committee CEN/TC 430 “Nuclear
energy, nuclear technologies, and radiological protection” the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2018, and conflicting national standards shall be
withdrawn at the latest by April 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 16638-1:2015 has been approved by CEN as EN ISO 16638-1:2017 without any
modification.
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
ISO 16638-1:2015(E)
© 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
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
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
iv © ISO 2015 – All rights reserved
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
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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).
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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.
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.
vi © ISO 2015 – All rights reserved
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.
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
2 © ISO 2015 – All rights reserved
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
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.
4 © ISO 2015 – All rights reserved
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
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
3.37
scattering factor
geometric standard deviation of the lognormal distribution of bioassay measurements
3.38
time of sampling
time at which the biological sample (e.g. urine, faeces) was provided by the individual
concerned, i.e. the end time of the collection period
3.39
time of measurement
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
E(50) Committed effective dose for an integration period of 50 years
e(50) Dose coefficient: committed effective dose per unit intake
f Gastro-intestinal uptake factor
I Intake
m(t ) Predicted value of the measured quantity at time, t , for unit intake (excretion or retention function
i i
at 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 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
ΔT Duration of the monitoring interval (in days)
ΔT/2 mid-time of the monitoring interval (in days)
6 © ISO 2015 – All rights reserved
ISO 16638-1:2015(E)
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
4.2 Abbreviated terms
AMAD Activity median aerodynamic diameter
CRM Certified reference material (ISO 28218)
DAC Derived air concentration
DIL Derived investigation level
DL Annual dose limit = 0,02 Sv
DRL Derived recording level
DU Depleted uranium (uranium with an assay of U-235 that is lower than its content in natural uranium)
HEU High enriched uranium (uranium with an assay of U-235 equal to or more than 20 %)
IARC International Agency for Research on Cancer
ICRP International Commission on Radiological Protection
LEU Low enriched uranium (uranium with an assay of U-235 from the natural level to 20 %)
LOAEL Lowest-observed-adverse-effect level
MRL Minimal risk level
NOAEL No-observed-adverse-effect level
PAS Personal air sampler
RPE Respiratory protective equipment
SAS Static air sampler
TRS Transfer reference standard (ISO 28218)
U-nat Uranium compound with natural isotopic composition
WHO World Health Organization
5 Purpose and need for monitoring programmes
Uranium compounds are considered a mixture of three major isotopes: U-234, U-235 and U-238; but in
certain cases U-233 and U-232 are also included. This International Standard describes four different
isotopic compositions representing natural (U-nat), depleted (DU), low (LEU) and high (HEU) enriched
uranium forms (see Table 1) based on their typical uranium isotopic compositions encountered in the
nuclear industry. Specific isotopic compositions should be used if available.
ISO 16638-1:2015(E)
Table 1 — Isotopic composition of natural uranium (U-nat), depleted uranium (DU), low
enriched uranium (LEU) and high enriched uranium (HEU), by mass and total uranium alpha
[20]
activities, based on specific activity values in ICRP 107
U-238 U-235 U-234
Alpha
Total
activity ratio
Isotopic Total Isotopic Total Isotopic Total
alpha
U-234/
composition alpha composition alpha composition alpha
activity
U-238
by mass activity by mass activity by mass activity
% % % % % % Bq/g
U-nat 99,275 48,26 0,72 2,25 0,0055 49,49 2,56E+04 1,03
DU 99,799 83,45 0,2 1,07 0,0010 15,48 1,49E+04 0,186
LEU 96,471 14,78 3,5 3,45 0,02884 81,78 8,12E+04 5,54
HEU 6,41 0,042 92,8 3,92 0,79 96,04 1,89E+06 2282
In industry, uranium can be present in a variety of chemical forms, often in association with other
radionuclides. In general, there is insufficient high quality data regarding inhalation by workers to be
able to determine the absorption parameters for uranium and, therefore, describe the biokinetics of the
material which would form the base 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. In order to
recommend material-specific dose coefficients and predict the biokinetics of uranium in humans, the
absorption parameter values obtained from the animal studies are combined with human deposition
[8]
and particle transport data obtained from the ICRP Human Respiratory Tract Model and the ICRP
[10]
systemic model for uranium ; 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,
monitoring forms part of the overall radiation protection programme. The programme 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, as described in ISO 20553.
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. Routine
monitoring programmes assume that working conditions and the risks of intake remain reasonably
constant. The design of this type of programme of regular measurements is heavily dependent on the
level of the annual dose, which shall be readily and reliably quantified. The level should be well below
legally relevant limits, accounting for uncertainties; for example, in activity measurement and dose
assessment. If the level is too high, intakes representing considerable fractions of dose limits could be
overlooked, while a low value may result in unnecessary efforts at low exposures.
Special monitoring is performed to quantify significant exposures following actual or suspected
abnormal events. 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
— assistance in decisions about countermeasures (e.g. decorporation therapy),
— compliance with legal regulations, and
— help to improve conditions in 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
determine individual retention and excretion functions and biokinetic model parameters.
8 © ISO 2015 – All rights reserved
ISO 16638-1:2015(E)
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.
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 8.2).
Workplace monitoring, which includes collective monitoring, provides exposure assessments for a group
of workers assuming identical working conditions, i.e. risks of intake as well as all factors influencing
the resulting doses. It is mainly used in cases where individual monitoring is not appropriate and it may
also be needed in those cases where individual monitoring is not sufficiently sensitive. In some cases
results of workplace monitoring are needed to support individual dose assessments (e.g. air monitoring
may provide information on the time of an intake).
Factors determining the extent of a monitoring programme are
— the magnitude of likely exposures,
— the requirement to identify accidental exposure events, and
— the need to assess the effectiveness of respiratory protective equipment (RPE).
In order to improve both risk assessment and management of uranium, there is a need for adapted
exposure limit values. The process of setting exposure limits begins with a careful analysis of
toxicological studies with relevant conditions of exposure, which is compared with actual exposure.
The final value takes into account the risk, as well as practical and economic constraints. Protective
values are regularly revised and modified depending on: new research, new risk assessment or
improvement of detection limits following new instrumental analysis methods. The toxicity of uranium
varies according to its chemical form and isotopic composition. Absorption rates differ with the
solubility of the compound. Those limits need to take into account both chemical and radiological risks.
Most regulatory bodies agree that uranium chemical toxicity is prevalent when uranium content in the
−1
kidney exceeds 3 μg g (retrospective) and for r
...
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