EN ISO 19238:2023

Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics - Dicentric assay (ISO 19238:2023)

This document provides criteria for quality assurance and quality control, evaluation of the performance and the accreditation of biological dosimetry by cytogenetic service laboratories using the dicentric assay performed with manual scoring.
This document is applicable to
a)    the confidentiality of personal information, for the requestor and the service laboratory,
b)    the laboratory safety requirements,
c)    the calibration sources and calibration dose ranges useful for establishing the reference dose-response curves that contribute to the dose estimation from unstable chromosome aberration frequency and the detection limit,
d)    the scoring procedure for unstable chromosome aberrations used for biological dosimetry,
e)    the criteria for converting a measured aberration frequency into an estimate of absorbed dose,
f)     the reporting of results,
g)    the quality assurance and quality control, and
h)    informative annexes containing sample instructions for requestor (see Annex A), sample questionnaire (see Annex B), sample report (see Annex C), fitting of the low dose-response curve by the method of maximum likelihood and calculating the error of the dose estimate (see Annex D), odds ratio method for cases of suspected exposure to a low dose (see Annex E), a method for determining the decision threshold and detection limit (see Annex F) and sample data sheet for recording aberrations (see Annex G).

Strahlenschutz - Durchführungskriterien für Dienstleistungslaboratorien zur Anwendung der biologischen Dosimetrie mittels zytogenetischer Verfahren - Dizentrische Chromosomenanalyse (ISO 19238:2023)

Dieses Dokument stellt Kriterien für die Qualitätssicherung und Qualitätskontrolle, Validierung der Durchführung und Akkreditierung der biologischen Dosimetrie durch zytogenetische Dienstleistungslaboratorien, die die dizentrische Chromosomenanalyse mit manueller Auswertung verwenden, bereit.
Dieses Dokument ist anwendbar auf:
a)   die Vertraulichkeit von persönlichen Angaben, in Bezug auf den Auftraggeber und das Dienstleistungslaboratorium;
b)   die Laboratorium-Sicherheitsanforderungen;
c)   die Kalibrierquellen (Kalibrierstrahler) und Kalibrierdosisbereiche, die zur Erstellung der Referenz-Dosis-Wirkungs-Kurven nützlich sind, die zur Dosisabschätzung anhand der Häufigkeit von instabilen Chromosomenaberrationen und der Nachweisgrenze beitragen;
d)   das Auswerteverfahren für instabile Chromosomenaberrationen, die für die biologische Dosimetrie verwendet werden;
e)   die Kriterien für die Abschätzung der absorbierten Dosis, anhand der Häufigkeit von beobachteten Aberrationen;
f)   die Berichterstattung der Ergebnisse;
g)   die Qualitätssicherung und Qualitätskontrolle, und
h)   informative Anhänge mit Musteranweisungen für Auftraggeber (siehe Anhang A), Musterfragebogen (siehe Anhang B), Musterbericht (siehe Anhang C), Anpassung der Niedrigdosis-Wirkungs-Kurve nach dem Maximum-Likelihood-Methode und Berechnung des Fehlers der Dosisschätzung (siehe Anhang D), Odds Ratio-Verfahren für Fälle einer vermuteten Exposition mit geringer Dosis (siehe Anhang E), sowie ein Verfahren zur Bestimmung der Erkennungsgrenze und Nachweisgrenze (siehe Anhang F) und ein Musterdatenblatt für die Erfassung der Aberrationen (siehe Anhang G).

Radioprotection - Critères de performance pour les laboratoires de service pratiquant la dosimétrie biologique par cytogénétique - Dénombrement des dicentriques (ISO 19238:2023)

Le présent document fournit des critères pour l’assurance qualité et le contrôle qualité, l’évaluation des performances et l’accréditation des laboratoires de service pratiquant la dosimétrie biologique par cytogénétique via un dénombrement manuel des dicentriques.
Le présent document s'applique à
a)    la confidentialité des informations personnelles pour le demandeur et le laboratoire de service,
b)    les exigences de sécurité du laboratoire,
c)    les sources d’étalonnage et les gammes de doses d’étalonnage utiles pour établir les courbes dose-réponse de référence qui contribuent à l’estimation de dose à partir de la fréquence des aberrations chromosomiques instables, et la limite de détection,
d)    la procédure de dénombrement des aberrations chromosomiques instables utilisées pour la dosimétrie biologique,
e)    les critères pour convertir une fréquence mesurée d’aberrations en une estimation de dose absorbée,
f)     la présentation des résultats,
g)    l’assurance qualité et le contrôle qualité, et
h)    les annexes informatives contenant des exemples: d’instructions pour le demandeur (voir Annexe A), de questionnaire (voir Annexe B), de rapport (voir Annexe C), d’ajustement de la courbe dose-réponse aux faibles doses par la méthode du maximum de vraisemblance et en tenant compte de l’erreur de l’estimation de dose (voir Annexe D), de méthode de rapport de chances pour les cas d’exposition suspectée à une faible dose(voir Annexe E), de méthode de détermination du seuil de décision et de la limite de détection (voir Annexe F) et de tableau type pour le dénombrement des aberrations chromosomiques (voir Annexe G).

Radiološka zaščita - Merila za delovanje laboratorijev, ki izvajajo biološko dozimetrijo s citogenetiko - Diecentrična analiza (ISO 19238:2023)

General Information

• Status: Published
• Publication Date: 05-Sep-2023
• ICS: 13.280 - Radiation protection
• ICS: 17.240 - Radiation measurements
• Technical Committee: CEN/TC 430 - Nuclear energy, nuclear technologies, and radiological protection
• Drafting Committee: CEN/TC 430 - Nuclear energy, nuclear technologies, and radiological protection
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 06-Sep-2023
• Completion Date: 06-Sep-2023
• Ref Project: SIST EN ISO 19238:2023 - Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics - Dicentric assay (ISO 19238:2023)

Relations

• Replaces: EN ISO 19238:2017 - Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics (ISO 19238:2014)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2023
Radiološka zaščita - Merila za delovanje laboratorijev, ki izvajajo biološko
dozimetrijo s citogenetiko - Diecentrična analiza (ISO 19238:2023)
Radiological protection - Performance criteria for service laboratories performing
biological dosimetry by cytogenetics - Dicentric assay (ISO 19238:2023)
Strahlenschutz - Durchführungskriterien für Dienstleistungslaboratorien zur Anwendung
der biologischen Dosimetrie mittels zytogenetischer Verfahren - Dizentrische
Chromosomenanalyse (ISO 19238:2023)
Radioprotection - Critères de performance pour les laboratoires de service pratiquant la
dosimétrie biologique par cytogénétique - Dénombrement des dicentriques (ISO
19238:2023)
Ta slovenski standard je istoveten z: EN ISO 19238:2023
ICS:
13.280 Varstvo pred sevanjem Radiation protection
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 19238
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2023
EUROPÄISCHE NORM
ICS 13.280; 17.240 Supersedes EN ISO 19238:2017
English Version
Radiological protection - Performance criteria for service
laboratories performing biological dosimetry by
cytogenetics - Dicentric assay (ISO 19238:2023)
Radioprotection - Critères de performance pour les Strahlenschutz - Durchführungskriterien für
laboratoires de service pratiquant la dosimétrie Dienstleistungslaboratorien zur Anwendung der
biologique par cytogénétique - Dénombrement des biologischen Dosimetrie mittels zytogenetischer
dicentriques (ISO 19238:2023) Verfahren - Dizentrische Chromosomenanalyse (ISO
19238:2023)
This European Standard was approved by CEN on 12 August 2023.

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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19238:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 19238:2023) has been prepared by Technical Committee ISO/TC 85 "Nuclear
energy, nuclear technologies, and radiological protection" in collaboration with 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 2024, and conflicting national standards shall
be withdrawn at the latest by March 2024.
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.
This document supersedes EN ISO 19238:2017.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. 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 19238:2023 has been approved by CEN as EN ISO 19238:2023 without any modification.

INTERNATIONAL ISO
STANDARD 19238
Third edition
2023-08
Radiological protection —
Performance criteria for service
laboratories performing biological
dosimetry by cytogenetics — Dicentric
assay
Radioprotection — Critères de performance pour les laboratoires
de service pratiquant la dosimétrie biologique par cytogénétique —
Dénombrement des dicentriques
Reference number
ISO 19238:2023(E)
ISO 19238:2023(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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 19238:2023(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 3
5 Dicentric assay . 4
6 Responsibility of the requestor . 5
7 Responsibility of the service laboratory . 5
7.1 Setup and sustainment of the QA program . 5
7.2 Responsibility during service . 5
8 Confidentiality of personal information . 6
8.1 Overview . 6
8.2 Applications of the principle of confidentiality . 7
8.2.1 Delegation of responsibilities within the laboratory. 7
8.2.2 Requests for analysis . . 7
8.2.3 Transmission of confidential information . 7
8.2.4 Anonymity of samples . 7
8.2.5 Reporting of results . 7
8.2.6 Storage . 7
8.2.7 Data security plan . 7
9 Laboratory safety requirements . 8
9.1 Overview . 8
9.2 Microbiological safety requirements . 8
9.3 Chemical safety . 8
9.4 Optical safety requirements . 9
10 Sample processing. 9
10.1 Culturing . 9
10.2 Scoring . 10
10.2.1 Coding of samples and slides . 10
10.2.2 Scoring techniques . 10
10.2.3 Procedure for scoring first-division metaphases . 10
10.2.4 Laboratory scoring expertise . 11
11 Calibration curves .11
11.1 Calibration source(s) . 11
11.2 Establishment of calibration curve(s) . 11
12 Criteria for converting a measured aberration frequency into an estimate of
absorbed dose .13
12.1 General .13
12.2 Testing the distribution of aberrations per cell . 13
12.3 Comparison with the background level: Characterisation of the minimum
detectable dose. 14
12.4 Confidence limits on the number of dicentrics . 16
12.5 Calculation of absorbed dose for whole-body exposures .
...