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)

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)

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-maj-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: prEN ISO 23588
ICS:
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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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 important technique in radiological protection. Along with the appropriate biokinetic
[5]
and dosimetric models, the results can be used to assess doses due to intakes of radionuclides . These
measurements and assessments are typically done
— routinely among radiation workers in occupational radiation protection, and
— among members of the public, emergency workers or helpers in a nuclear or radiological emergency.
In vivo monitoring may also be used to identify the level of exposure of an individual in a criticality
[5]
incident through the measurement of activated body sodium .
In vivo measurements may be made by dosimetry laboratories with dedicated facilities, in nuclear
facilities using whole-body or partial body scanners, or in hospitals or universities with appropriate
equipment. The most common direct (in vivo) methods are whole-body, lung, and thyroid counting.
Participating in performance testing programmes with suitable phantoms is commonly required
by national regulatory bodies as part of the accreditation of in vivo dosimetry service laboratories
for the validation of bioassay methods. For other facilities making in vivo measurements, such as
nuclear facilities, hospitals, and universities, participating in intercomparisons can help monitor the
performance, identify problems, and provide education and training opportunities. ISO 28218 provides
performance criteria for radiobioassay including in vivo monitoring. The general design requirements
and performance characteristics of in vivo measurement instrumentation, including test procedures
[4]
for performance control, are described in IEC 61582 .
General requirements on proficiency testing and statistical methods for evaluation are given
[3] [2]
in ISO/IEC 17043 and ISO 13528 , respectively.
The purpose of this document is to give a fuller set of requirements and recommendations for
proficiency test organizers than given in the standards mentioned above, including
— planning and announcement of testing actions,
— selection of radionuclides,
— selection of activities to be used for testing,
— preparation of test sources,
— selection of phantoms,
— measurement of phantoms,
— analysis of results provided by the participants, and
— reporting.
v
INTERNATIONAL STANDARD ISO 23588:2023(E)
Radiological protection — General requirements for
proficiency tests for in vivo radiobioassay
1 Scope
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.
It specifies minimum requirements for proficiency testing applicable to dosimetry laboratories that
have dedicated facilities for in vivo monitoring and where accreditation is required as part of providing
the service. It also provides general requirements for proficiency testing that may include a larger
group of non-accredited laboratories that may perform measurements as part of worker surveillance
or in response to an emergency.
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 28218:2010, Radiation protection — Performance criteria for radiobioassay
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standard
...

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