oSIST prEN 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)

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 doze za množične žrtve v radioloških ali jedrskih nesrečah - Splošna načela in uporaba za dicentrični test (ISO 21243:2022)

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Jul-2025
• ICS: 13.280 - Radiation protection
• ICS: 27.120.20 - Nuclear power plants. Safety
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 05-Jun-2025
• Due Date: 23-Oct-2025
• Ref Project: prEN ISO 21243 - 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)

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2025
Radiološka zaščita - Merila za delovanje laboratorijev, ki izvajajo začetno
citogenetsko oceno doze za množične žrtve v radioloških ali jedrskih nesrečah -
Splošna načela in uporaba za dicentrični test (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: prEN ISO 21243
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.

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
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or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: [phone]
Email: [e-mail]
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 .15
Annex C (informative) Example group sample report .16
Bibliography .18
iii
ISO 21243:2022(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 on 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 the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 85, Nuclear energy, Subcommittee SC 2,
Radiological protection.
This second edition cancels and replaces the first edition (ISO 21243:2008), which has been technically
revised.
The main changes are as follows:
— Annex D (Estimates of dose and 95 % confidence limits for selected observations of numbers of
dicentrics and cells) has been removed;
— in 8.1, General: the number of cells to be scored has been moved to Annex B;
— in 8.2, Whole body exposure: addition of a description of when not to assume an acute exposure by
looking at the variance/mean and a phrase stating that for low LET radiation doses below ~0.3Gy,
linearity can be assumed (as with high LET).
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 21243:2022(E)
Introduction
The potential for nuclear and radiological emergencies involving mass casualties from accidental or
malicious acts recommends generic procedures for initial dose assessment to help the development of
medical response capabilities. A mass-casualty incident is defined here as an event that exceeds the
local medical resources. Biological dosimetry, based on cytogenetic analysis using the dicentric assay,
typically applied for accidental dose assessment, has been defined in ISO 19238. Initial assessment refers
to an expedited version of the dicentric assay that evaluates chromosome damage in a small number of
cells and would be used in an emergency situation where rapid analysis is needed. This results in an
estimated dose with high uncertainty but allows for exposure categorization. This document focuses
on the use of the dicentric assay for initial cytogenetic analysis in the case of mass-casualty incidents.
Many of the concepts discussed here can be applied to other biological dosimetry methods. The initial
dose evaluation/categorization performed according to this document can be complemented by a more
det
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