EN ISO 16638-2:2022
(Main)Radiological protection - Monitoring and internal dosimetry for specific materials - Part 2: Ingestion of uranium compounds (ISO 16638-2:2019)
Radiological protection - Monitoring and internal dosimetry for specific materials - Part 2: Ingestion of uranium compounds (ISO 16638-2:2019)
This document specifies the minimum requirements for the design of professional programmes to monitor workers exposed to a risk of ingestion to uranium compounds. This document 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 standardized 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 need to be applied.
This document addresses those circumstances when exposure could be constrained by either radiological or chemical toxicity concerns.
This document addresses, for ingestion of uranium and its compounds, the following items:
a) purposes of monitoring and monitoring programmes;
b) description of the different categories of monitoring programmes;
c) suitable methods for monitoring and criteria for their selection;
d) information that is collected for the design of a monitoring programme;
e) procedures for dose assessment based on reference levels for special monitoring programmes;
f) criteria for determining the significance of monitoring results;
g) uncertainties arising from dose assessment and interpretation of bioassays data;
h) reporting/documentation;
i) quality assurance;
j) record keeping requirements.
It is not applicable to the following items:
a) detailed descriptions of measuring methods and techniques for uranium;
b) modelling for the improvement of internal dosimetry;
c) potential influence of counter-measures (e.g. administration of chelating agents);
d) investigation of the causes or implications of an exposure;
e) dosimetry for inhalation exposures and for contaminated wounds.
Strahlenschutz - Überwachung und interne Dosimetrie für bestimmte Stoffe - Teil 2: Ingestion von Uranverbindungen (ISO 16638-2:2019)
Dieses Dokument legt die Mindestanforderungen für die Auslegung von professionellen Programmen zur Überwachung von Beschäftigten fest, die einem Risiko der Ingestion von Uranverbindungen ausgesetzt sind. Dieses Dokument legt Grundsätze für die Entwicklung kompatibler Ziele und Anforderungen für Überwachungsprogramme und die Dosisabschätzung für Beschäftigte fest, die beruflich einer internen Kontamination ausgesetzt sind. Es legt Verfahren und Annahmen für Risikoanalysen, Überwachungsprogramme und die standardisierte Interpretation von Überwachungsdaten fest, um akzeptable Zuverlässigkeitsniveaus für Uran und seine Verbindungen zu erreichen. Es legt Grenzwerte für die Anwendbarkeit der Verfahren in Bezug auf Dosiswerte fest, oberhalb derer anspruchsvollere Methoden angewendet werden müssen.
Dieses Dokument behandelt solche Umstände, unter denen die Exposition durch Überlegungen entweder zu radiologischer oder chemischer Toxizität begrenzt werden könnte.
Dieses Dokument behandelt für die Ingestion von Uran und seinen Verbindungen die folgenden Punkte:
a) Zwecke der Überwachung und der Überwachungsprogramme;
b) Beschreibung der verschiedenen Kategorien von Überwachungsprogrammen;
c) geeignete Methoden zur Überwachung und Kriterien für ihre Auswahl;
d) Informationen, die für die Auslegung eines Überwachungsprogramms gesammelt werden;
e) Verfahren für die Dosisabschätzung basierend auf Referenzwerten für besondere Überwachungsprogramme;
f) Kriterien zur Bestimmung der Bedeutsamkeit von Überwachungsergebnissen;
g) Unsicherheiten, die sich aus der Dosisabschätzung und der Interpretation von Ergebnissen der Inkorporationsmessungen ergeben;
h) Befundung/Dokumentation;
i) Qualitätssicherung;
j) Anforderungen an die Aufzeichnung.
Es ist nicht anwendbar auf die folgenden Punkte:
a) detaillierte Beschreibungen der Messmethoden und -techniken für Uran;
b) Modellierung für die Verbesserung der internen Dosimetrie;
c) möglicher Einfluss von Gegenmaßnahmen (z. B. Gabe von Komplexbildnern);
d) Untersuchung der Ursachen oder Implikationen einer Exposition;
e) Dosimetrie für Inhalationsexposition und für kontaminierte Wunden.
Radioprotection - Contrôle et dosimétrie interne des éléments spécifiques - Partie 2 : Ingestion de composés d'uranium (ISO 16638-2:2019)
Le présent document décrit les exigences minimales permettant d'établir des programmes de surveillance professionnelle des travailleurs exposés à un risque d'ingestion de composés de l'uranium. Le présent document 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 le cadre de leur travail, à une contamination interne. Il 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. Il fixe des limites pour l'applicabilité des procédures concernant les niveaux de dose au-delà desquels il est nécessaire d'appliquer des méthodes plus sophistiquées.
Le présent document traite des circonstances dans lesquelles l'exposition peut être assujettie aux problèmes liés à la toxicité radiologique ou chimique.
Le présent document traite, pour l'ingestion d'uranium et de ses composés, des éléments suivants:
a) les objectifs de la surveillance et les programmes de surveillance;
b) la description des différentes catégories de programmes de surveillance;
c) les méthodes valables pour la surveillance et leurs critères de sélection;
d) les informations collectées pour l'élaboration d'un programme de surveillance;
e) les procédures d'estimation dosimétrique basées sur les niveaux de référence utilisés pour les programmes de surveillance spéciale;
f) les critères pour la détermination de l'importance des résultats de la surveillance;
g) les incertitudes liées à l'estimation dosimétrique et l'interprétation des résultats sur échantillons biologiques;
h) la transmission et la documentation;
i) l'assurance de la qualité;
j) les exigences en matière de conservation des enregistrements.
Il ne s'applique pas aux éléments suivants:
a) les descriptions détaillées des méthodes et des techniques de mesurage concernant l'uranium;
b) la modélisation pour l'amélioration de la dosimétrie interne;
c) l'influence potentielle de l'action des agents décorporants (par exemple administration d'agents complexants);
d) l'investigation des causes et des conséquences d'une exposition;
e) la dosimétrie pour les expositions par inhalation et par blessures
Radiološka zaščita - Nadzorovanje in notranja dozimetrija za posebne materiale - 2. del: Zaužitje uranovih spojin (ISO 16638-2:2019)
Ta dokument določa minimalne zahteve za načrtovanje profesionalnih programov za nadzor delavcev, ki so izpostavljeni tveganju za zaužitje uranovih spojin. Ta dokument določa načela za razvoj združljivih ciljev in zahtev za nadzorne programe ter ocenjevanje odmerkov za delavce, ki so poklicno izpostavljeni notranji kontaminaciji. Določa postopke in predpostavke za analizo tveganja, nadzorne programe ter standardizirano interpretacijo nadzornih podatkov za doseganje sprejemljivih ravni zanesljivosti za uran in uranove spojine. Postavlja meje ravni odmerkov za uporabo postopkov, nad katerimi je treba uporabiti naprednejše metode.
Ta dokument obravnava okoliščine, ko je izpostavljenost lahko omejena zaradi radiološke ali kemijske toksičnosti.
Ta dokument v zvezi z zaužitjem urana in njegovih spojin obravnava:
a) namene nadzora in nadzornih programov;
b) opis različnih kategorij nadzornih programov;
c) primerne metode za izvajanje nadzora in kriterije za izbiro metod;
d) informacije, ki se zbirajo za načrtovanje nadzornega programa;
e) postopke za ocenjevanje odmerkov glede na referenčne ravni za posebne nadzorne programe;
f) kriterije za določanje pomena rezultatov nadzora;
g) negotovosti, ki izhajajo iz ocenjevanja odmerkov in interpretacije podatkov bioloških preizkusov;
h) poročanje/dokumentiranje;
i) zagotavljanje kakovosti;
j) zahteve za vodenje evidenc.
Ne uporablja se za:
a) podrobno opisovanje merilnih metod in tehnik za uran;
b) modeliranje za izboljševanje notranje dozimetrije;
c) možne vplive protiukrepov (npr. dovajanja kelatov);
d) raziskovanje razlogov ali vplivov izpostavljenosti;
e) dozimetrijo pri izpostavljenosti ob vdihavanju in kontaminiranih ranah.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2022
Radiološka zaščita - Nadzorovanje in notranja dozimetrija za posebne materiale -
2. del: Zaužitje uranovih spojin (ISO 16638-2:2019)
Radiological protection - Monitoring and internal dosimetry for specific materials - Part 2:
Ingestion of uranium compounds (ISO 16638-2:2019)
Strahlenschutz - Überwachung und interne Dosimetrie für bestimmte Stoffe - Teil 2:
Ingestion von Uranverbindungen (ISO 16638-2:2019)
Radioprotection - Contrôle et dosimétrie interne des éléments spécifiques - Partie 2:
Ingestion de composés d'uranium (ISO 16638-2:2019)
Ta slovenski standard je istoveten z: EN ISO 16638-2:2022
ICS:
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 16638-2
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2022
EUROPÄISCHE NORM
ICS 17.240
English Version
Radiological protection - Monitoring and internal
dosimetry for specific materials - Part 2: Ingestion of
uranium compounds (ISO 16638-2:2019)
Radioprotection - Contrôle et dosimétrie interne des Strahlenschutz - Überwachung und interne Dosimetrie
éléments spécifiques - Partie 2: Ingestion de composés für bestimmte Stoffe - Teil 2: Ingestion von
d'uranium (ISO 16638-2:2019) Uranverbindungen (ISO 16638-2:2019)
This European Standard was approved by CEN on 24 July 2022.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16638-2:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex G (informative) A-deviations . 4
European foreword
The text of ISO 16638-2:2019 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 16638-2:2022 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 February 2023, and conflicting national standards
shall be withdrawn at the latest by February 2023.
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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 16638-2:2019 has been approved by CEN as EN ISO 16638-2:2022 without any
modification.
Annex G
(informative)
A-deviations
A-deviation: National deviation due to regulations, the alteration of which is for the time being
outside the competence of the CEN-CENELEC national member.
This European Standard does not fall under any Directive/Regulation of the EU.
In the relevant CEN-CENELEC countries, these A-deviations are valid instead of the respective
provisions of the European Standard until the national situation causing the A-deviation has
changed.
Clause Deviation
General Germany
Incorporation monitoring in Germany is legally regulated by the German
Guidelines on physical radiation protection control for determination of
the body dose part 2: Determination of the body dose of internal
exposition (incorporation monitoring) of January 12, 2007
Regarding the measurements and the quality control described in this
clauses shall comply with the guideline on physical radiation protection
control for determination of the body dose part 2: Determination of the
body dose of internal exposition (incorporation monitoring) of January 12,
11.3 Germany
Measurement uncertainties as described in this clause are legally not
taken into account in Germany.
INTERNATIONAL ISO
STANDARD 16638-2
First edition
2019-11
Radiological protection — Monitoring
and internal dosimetry for specific
materials —
Part 2:
Ingestion of uranium compounds
Radioprotection — Contrôle et dosimétrie interne des éléments
spécifiques —
Partie 2: Ingestion de composés d'uranium
Reference number
ISO 16638-2:2019(E)
©
ISO 2019
ISO 16638-2:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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ii © ISO 2019 – All rights reserved
ISO 16638-2:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 4
4.1 Symbols . 4
4.2 Abbreviated terms . 5
5 Purpose and need for monitoring programmes . 5
6 General aspects . 7
7 Special monitoring programmes . 8
8 Task-related monitoring programmes for individual monitoring . 8
9 Reference values as performance criteria for laboratories . 8
10 Quality assurance and quality control for bioassay laboratories .9
11 Procedure for the assessment of exposures .10
11.1 Assessment of indi vidual monitoring data .10
11.2 Properties of a software tool .10
11.3 Uncertainties .11
11.4 Quality assurance of the assessment process .11
12 Reporting and documentation .12
12.1 Reporting results for in vitro measurements .12
12.2 Documentation of the dose assessment .12
Annex A (informative) Nuclear data of U-238 and U-235 decay .14
Annex B (informative) Default classification of uranium compounds .15
Annex C (informative) Measurement techniques for uranium in case of ingestion .16
Annex D (informative) Excretion rates for ingestion of uranium compounds .19
Annex E (informative) Committed effective dose per unit intake after ingestion of uranium
compounds .21
Annex F (informative) Estimation of uncertainties for internal dose assessments after ingestion 22
Bibliography .25
ISO 16638-2:2019(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
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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).
Any trade name used in this document is information given for the convenience of use
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