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SIST EN ISO 21243:2025

(Main)

Radiation protection - Performance criteria for laboratories performing initial cytogenetic dose assessment of mass casualties in radiological or nuclear emergencies - General principles and application to dicentric assay (ISO 21243:2022)

Radiation protection - Performance criteria for laboratories performing initial cytogenetic dose assessment of mass casualties in radiological or nuclear emergencies - General principles and application to dicentric assay (ISO 21243:2022)

The purpose of this document is to give an overview of the minimum requirements for performing the dicentric assay with quality control measures using mitogen stimulated peripheral blood lymphocytes for initial assessment of individuals involved in a mass casualty scenario. The dicentric assay is the use of chromosome damage to quickly estimate approximate radiation doses received by individuals in order to supplement the early clinical categorization of casualties.
This document focuses on the organizational and operational aspects of applying the dicentric assay in an initial assessment mode. The technical aspects of the dicentric assay can be found in ISO 19238.
This document is applicable either to an experienced biological dosimetry laboratory working alone or to a network of collaborating laboratories (as defined in Clause 7).

Strahlenschutz - Leistungskriterien für Laboratorien, die zytogenetische Triage zur Beurteilung von Massenunfällen in radiologischen oder nuklearen Notfällen - Allgemeine Grundsätze und Anwendung für dizentrisches Prüfverfahren (ISO 21243:2022)

Radioprotection - Critères de performance pour les laboratoires pratiquant l’estimation dosimétrique préliminaire par cytogénétique en cas d’accident radiologique ou nucléaire affectant un grand nombre de personnes - Principes généraux et application au test dicentrique (ISO 21243:2022)

Radiološka zaščita - Merila za delovanje laboratorijev, ki izvajajo začetno citogenetsko oceno prejete doze pri množičnih žrtvah v radioloških ali jedrskih nesrečah - Splošna načela in uporaba dicentričnega testa (ISO 21243:2022)

General Information

Status
Published
Public Enquiry End Date
30-Jul-2025
Publication Date
15-Oct-2025
ICS
13.280 - Radiation protection
27.120.20 - Nuclear power plants. Safety
Technical Committee
I13 - Imaginarni 13
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
09-Oct-2025
Due Date
14-Dec-2025
Completion Date
16-Oct-2025
Ref Project
EN ISO 21243:2025 - Radiation protection - Performance criteria for laboratories performing initial cytogenetic dose assessment of mass casualties in radiological or nuclear emergencies - General principles and application to dicentric assay (ISO 21243:2022)
SIST EN ISO 21243:2025SIST EN ISO 21243:2025
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SIST EN ISO 21243:2025
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SLOVENSKI STANDARD
01-december-2025
Radiološka zaščita - Merila za delovanje laboratorijev, ki izvajajo začetno
citogenetsko oceno prejete doze pri množičnih žrtvah v radioloških ali jedrskih
nesrečah - Splošna načela in uporaba dicentričnega testa (ISO 21243:2022)
Radiation protection - Performance criteria for laboratories performing initial cytogenetic
dose assessment of mass casualties in radiological or nuclear emergencies - General
principles and application to dicentric assay (ISO 21243:2022)
Strahlenschutz - Leistungskriterien für Laboratorien, die zytogenetische Triage zur
Beurteilung von Massenunfällen in radiologischen oder nuklearen Notfällen - Allgemeine
Grundsätze und Anwendung für dizentrisches Prüfverfahren (ISO 21243:2022)
Radioprotection - Critères de performance pour les laboratoires pratiquant l’estimation
dosimétrique préliminaire par cytogénétique en cas d’accident radiologique ou nucléaire
affectant un grand nombre de personnes - Principes généraux et application au test
dicentrique (ISO 21243:2022)
Ta slovenski standard je istoveten z: EN ISO 21243:2025
ICS:
13.280 Varstvo pred sevanjem Radiation protection
27.120.20 Jedrske elektrarne. Varnost Nuclear power plants. Safety
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21243
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2025
EUROPÄISCHE NORM
ICS 13.280; 27.120.20
English Version
Radiation protection - Performance criteria for
laboratories performing initial cytogenetic dose
assessment of mass casualties in radiological or nuclear
emergencies - General principles and application to
dicentric assay (ISO 21243:2022)
Radioprotection - Critères de performance pour les Strahlenschutz - Leistungskriterien für Laboratorien,
laboratoires pratiquant l'estimation dosimétrique die zytogenetische Triage zur Beurteilung von
préliminaire par cytogénétique en cas d'accident Massenunfällen in radiologischen oder nuklearen
radiologique ou nucléaire affectant un grand nombre Notfällen - Allgemeine Grundsätze und Anwendung für
de personnes - Principes généraux et application au dizentrisches Prüfverfahren (ISO 21243:2022)
test dicentrique (ISO 21243:2022)
This European Standard was approved by CEN on 22 September 2025.

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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21243:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 21243:2022 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 21243:2025 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 March 2026, and conflicting national standards shall
be withdrawn at the latest by March 2026.
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 21243:2022 has been approved by CEN as EN ISO 21243:2025 without any modification.

INTERNATIONAL ISO
STANDARD 21243
Second edition
2022-11
Radiation protection — Performance
criteria for laboratories performing
initial cytogenetic dose assessment
of mass casualties in radiological
or nuclear emergencies — General
principles and application to dicentric
assay
Radioprotection — Critères de performance pour les laboratoires
pratiquant l’estimation dosimétrique préliminaire par cytogénétique
en cas d’accident radiologique ou nucléaire affectant un grand
nombre de personnes — Principes généraux et application au test
dicentrique
Reference number
ISO 21243:2022(E)
ISO 21243:2022(E)
© ISO 2022
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 21243:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Responsibility of the laboratory . 3
4.1 Awareness of this document . 3
4.2 Biological dosimetry request and confidentiality . 3
4.3 Pre-planning . 4
4.4 Responsibility during service . 4
5 Biological dosimetry process in radiological or nuclear mass-casualty incidents .5
6 Emergency response of the lead laboratory . 5
7 Design of a laboratory network .5
7.1 Overview . 5
7.2 Preparedness of the laboratory network . 6
7.3 Laboratory network operation . 6
7.3.1 General . 6
7.3.2 Lead laboratory responsibilities . 7
7.3.3 Associate laboratory responsibilities . 7
8 Expected results . 8
8.1 General . 8
8.2 Whole-body exposure . 8
8.3 Inhomogeneous exposure . 9
9 Quality assurance and quality control . 9
9.1 Overview . 9
9.2 Quality control . 10
9.2.1 General . 10
9.2.2 Quality control procedures . 10
9.2.3 Performance checks of sample transport integrity . 10
9.2.4 Performance checks of sample integrity by the laboratory . 10
9.2.5 Performance checks of instrumentation . 10
9.2.6 Performance checks of sample protocol . 11
9.2.7 Performance checks of exposure categorization . 11
9.2.8 Performance checks of sample scoring . 11
9.2.9 Performance checks of dose and confidence intervals estimation . 11
9.2.10 Performance checks of the generation of reports results . 11
9.2.11 Performance checks of a data security plan . 11
9.2.12 Performance of the network .12
Annex A (informative) Interactions between requestors and biological dosimetry
laboratories .13
Annex B (informative) Guidance for threshold of detection when the dicentric assay is
analysed using manual scoring procedures .
...

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