SIST EN ISO 23588:2024
(Main)Radiological protection - General requirements for proficiency tests for in vivo radiobioassay (ISO 23588:2023)
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
Standards Content (Sample)
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 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 standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
activity distribution
information about the spatial distribution of the provided activity in a phantom, to be used as a basis
for the choice of an efficiency calibration by the participant
Note 1 to entry: Examples of activity distributions are activity in the whole-body, lung, skull or thyroid.
3.2
attendant
person appointed by the organizing laboratory (3.4) to attend the participants during their
measurements for the proficiency test
ISO 23588:2023(E)
3.3
minimum testing level
MTL
amount of radioactive material that the service laboratory is intended to be able to measure for
participation in the performance testing programme, assuming the samples are free of interference
from other radionuclides, unless specifically addressed
Note 1 to entry: The MTLs are not intended to be interpreted as the appropriate detection limit required for
a specific internal dosimetry programme, but rather as an acceptable minimum testing level for radiobioassay
service laboratories based on good measurement practice.
[SOURCE: ISO 28218:2010, 3.18]
3.4
organizer
organizing laboratory
institution or consortium of institutions that provides the proficiency test
3.5
participant
participating laboratory
laboratory whose proficiency is tested as described in this document
3.6
partial body counter
PBC
equipment for the determination of activity in a region of the body
3.7
test result
information about the performance of the individual participant (3.5), prepared and dispatched by the
organizer (3.4)
3.8
whole-body counter
WBC
equipment for the determination of the presence, location and/or amount of radioactivity in the body
[1]
[SOURCE: ISO 12749-2:2022 , 3.4.9]
4 Planning
4.1 Determination of the type of proficiency test
4.1.1 The organizer shall clearly define the purpose of the proficiency test. The purpose should
encompass
— the aims of the proficiency test, for example to test the proficiency of accredited dosimetry service
laboratories to set criteria or to provide information on the performance of facilities and laboratories
that would be used in response to an emergency,
— the radionuclides, or categories of radionuclides, that are the subject of the proficiency test
(see Annex B and Annex C),
— the MTLs for these radionuclides, or categories of radionuclides (see Annex C),
— the types of laboratories or facilities that are eligible to participate in the test,
— the type of proficiency test, for example whether it is for a single laboratory to set criteria
(measurement audit) or a sequential participation test with a phantom, and
ISO 23588:2023(E)
— the statistical analyses that are used to determine the performance of participants in the proficiency
test.
4.1.2 The organizer shall draft a schedule for the proficiency test. Annex A provides an example
timeline for a proficiency test.
4.2 Choice of measurement tasks
4.2.1 The organizer shall decide which radionuclides, or groups of radionuclides, shall be included
in the test based upon the objectives of the proficiency test. The choice of the body region to be
tested, either whole-body or a particular organ such as the lung or thyroid, should be relevant to
those radionuclides based on a particular exposure scenario (inhalation, ingestion, wound) and their
biokinetics inside the body. ISO 28218 and Annex B provide details of appropriate body regions to be
tested for various categories of radionuclides under certain exposure scenarios.
4.3 Selection of radionuclides
4.3.1 The radionuclides used in the test shall be selected from the list provided in
ISO 28218:2010, Table 1 or Annex C in accordance with the group of radionuclides and type of in vivo
measurement being tested.
4.3.2 The organizer may choose to use surrogate radionuclides instead of the primary radionuclide of
interest based on practical considerations such as half-life in relation to the timescale of the proficiency
test, external dose incurred during preparation and use, ease of production, and shipping, and expense.
NOTE Ba-133 (or Ba-133 and Cs-137) can substitute for I-131 in regularly performed proficiency tests,
and I-125 can be replaced by I-129 for economic reasons. Because of the multiplicity of their emission lines,
Ba-133
...
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