Radiological protection - General requirements for proficiency tests for in vivo radiobioassay (ISO 23588:2023)

This document specifies general requirements for proficiency tests that are offered to in vivo bioassay measurement facilities operating a whole-body counter (WBC) or partial body counter (PBC) for monitoring of persons.
This document covers proficiency tests that involve only the quantification of radionuclides and tests that require the identification of radionuclides and their activity.
This document does not define specific requirements on administrative aspects of proficiency testing, such as shipping and finance, that may be the subject of national or international regulation.

Strahlenschutz - Allgemeine Anforderungen an Eignungsprüfungen für in‑vivo Bioassays (ISO 23588:2023)

Dieses Dokument legt die allgemeinen Anforderungen für Eignungsprüfungen fest, die Einrichtungen für In-vivo-Inkorporationsmessungen angeboten werden, welche einen Ganzkörperzähler (WBC, en: whole-body counter) oder Teilkörperzähler (PBC, en: partial body counter) zur Überwachung von Personen betreiben.
Es legt außerdem die Mindestanforderungen für Eignungsprüfungen fest, die für Dosimetrie-Laboratorien gelten, die über spezielle Einrichtungen für die In-vivo-Überwachung verfügen und bei denen im Rahmen der Bereitstellung dieser Dienstleistung eine Akkreditierung erforderlich ist. Es enthält darüber hinaus allgemeine Anforderungen für Eignungsprüfungen, bei denen eine größere Gruppe nicht akkreditierter Laboratorien berücksichtigt werden kann, die im Rahmen der Arbeitnehmerüberwachung oder als Reaktion auf einen Notfall Messungen durchführen.
Dieses Dokument behandelt die Eignungsprüfungen, die nur die Quantifizierung von Radionukliden berücksichtigen, sowie die Prüfungen, die die Identifizierung von Radionukliden und deren Aktivität erfordern.
Es legt keine spezifischen Anforderungen für die administrativen Aspekte von Eignungsprüfungen fest, wie z. B. den Versand und die Finanzierung, die Gegenstand nationaler oder internationaler Vorschriften sein können.

Radioprotection - Exigences générales concernant les essais d’aptitude pour les mesures d'anthroporadiométrie (mesures in vivo) (ISO 23588:2023)

Radiološka zaščita - Splošne zahteve za preskuse strokovne usposobljenosti za radiobioanalizo in vivo (ISO 23588:2023)

Ta dokument določa splošne zahteve za preskuse strokovne usposobljenosti, ki so na voljo za merilne naprave z biološko analizo in vivo, ki uporabljajo števec za merjenje radioaktivnosti celotnega telesa (WBC) ali števec za merjenje radioaktivnosti posameznih delov telesa (PBC) za spremljanje oseb.
Ta dokument zajema preskuse strokovne usposobljenosti, ki vključujejo samo kvantifikacijo radionuklidov, ter preskuse, ki zahtevajo identifikacijo radionuklidov in njihove aktivnosti.
Ta dokument ne opredeljuje posebnih zahtev glede upravnih vidikov preskušanja strokovne usposobljenosti, kot sta odprema in financiranje, za katere lahko veljajo nacionalni ali mednarodni predpisi.

General Information

Status
Published
Publication Date
16-Jul-2024
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
17-Jul-2024
Due Date
18-Apr-2026
Completion Date
17-Jul-2024

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SLOVENSKI STANDARD
01-september-2024
Radiološka zaščita - Splošne zahteve za preskuse strokovne usposobljenosti za
radiobioanalizo in vivo (ISO 23588:2023)
Radiological protection - General requirements for proficiency tests for in vivo
radiobioassay (ISO 23588:2023)
Strahlenschutz - Allgemeine Anforderungen an Eignungsprüfungen für in‑vivo
Bioassays (ISO 23588:2023)
Radioprotection - Exigences générales concernant les essais d’aptitude pour les
mesures d'anthroporadiométrie (mesures in vivo) (ISO 23588:2023)
Ta slovenski standard je istoveten z: EN ISO 23588:2024
ICS:
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 23588
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2024
EUROPÄISCHE NORM
ICS 13.280
English Version
Radiological protection - General requirements for
proficiency tests for in vivo radiobioassay (ISO
23588:2023)
Radioprotection - Exigences générales concernant les Strahlenschutz - Allgemeine Anforderungen an
essais d'aptitude pour les mesures Eignungsprüfungen für in-vivo Bioassays (ISO
d'anthroporadiométrie (mesures in vivo) (ISO 23588:2023)
23588:2023)
This European Standard was approved by CEN on 7 July 2024.

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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23588:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 23588:2023 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 23588:2024 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 January 2025, and conflicting national standards shall
be withdrawn at the latest by January 2025.
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 23588:2023 has been approved by CEN as EN ISO 23588:2024 without any modification.

INTERNATIONAL ISO
STANDARD 23588
First edition
2023-02
Radiological protection — General
requirements for proficiency tests for
in vivo radiobioassay
Radioprotection — Exigences générales concernant les essais
d’aptitude pour les mesures d'anthroporadiométrie (mesures in vivo)
Reference number
ISO 23588:2023(E)
ISO 23588:2023(E)
© ISO 2023
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 on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 23588:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Planning . 2
4.1 Determination of the type of proficiency test . 2
4.2 Choice of measurement tasks . 3
4.3 Selection of radionuclides . 3
4.4 Selection of activity ranges . 3
4.5 Choice of phantom . 4
4.6 Announcement of the proficiency test. 4
5 Preparation of phantoms and sources . 5
5.1 Preparation of phantoms . 5
5.2 Preparation of sources . 5
5.3 Quality assurance . 5
6 Conducting the proficiency test . 5
6.1 General . 5
6.2 Preparation of the phantom at the participant’s facility . 6
6.3 Measurement of the phantom by the participants . 6
6.4 Reporting protocol . 6
7 Data analysis and evaluation of results . 7
7.1 General . 7
7.2 Determination of the assigned value . 7
7.3 Calculation of the performance scores . 8
7.4 Report . 8
Annex A (informative) Example schedule for a proficiency test . 9
Annex B (informative) Example measurement tasks .10
Annex C (normative) MTL for in vivo radiobioassay performance testing .11
Annex D (informative) Examples of phantoms .12
Bibliography .13
iii
ISO 23588:2023(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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technology,
and radiological protection, Subcommittee SC 2, Radiological protection.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO 23588:2023(E)
Introduction
The direct (in vivo) measurement of radionuclides emitting penetrating radiations (X- and gamma rays)
in the body is an i
...

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