EN ISO 20046:2021

Radiological protection - Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation (ISO 20046:2019)

The purpose of this document is to provide criteria for quality assurance (QA), quality control (QC) and evaluation of the performance of biological dosimetry by cytogenetic service laboratories.
This document addresses:
a)    the responsibilities of both the customer and the laboratory;
b)    the confidentiality of personal information, for the customer and the laboratory;
c)    the laboratory safety requirements;
d)    sample processing; culturing, staining and scoring, including the criteria for scoring for translocation analysis by FISH;
e)    the calibration sources and calibration dose ranges useful for establishing the reference dose‑response curves that contribute to the dose estimation from chromosome aberration frequency and the detection limit;
f)     the scoring procedure for translocations stained by FISH used for evaluation of exposure;
g)    the criteria for converting a measured aberration frequency into an estimate of absorbed dose (also appears as "dose");
h)    the reporting of results;
i)     the QA and QC;
j)     Annexes A to F containing sample instructions for the customer, sample questionnaire, sample datasheet for recording aberrations, sample of report and fitting of the low dose-response curve by the method of maximum likelihood and calculating the uncertainty of dose estimate.

Strahlenschutz - Leistungskriterien für Laboratorien, die den Fluoreszenz-in-situ-Hybridisierungs-(FISH)-Translokationstest zur Bewertung der Exposition gegenüber ionisierender Strahlung verwenden (ISO 20046:2019)

Der Zweck dieses Dokuments ist es, Kriterien für die Qualitätssicherung (QA), für die Qualitätskontrolle (QC) sowie für die Leistungsbewertung der biologischen Dosimetrie durch zytogenetische Service-Laboratorien bereitzustellen.
Dieses Dokument behandelt Folgendes:
a) Verantwortung des Kunden und des Laboratoriums;
b) vertraulicher Umgang mit personenbezogenen Daten beim Kunden und im Laboratorium;
c) Sicherheitsanforderungen im Laboratorium;
d) Durchführung der Probenahme; Kultivierung, Anfärbung und Bewertung, einschließlich der Kriterien für die Bewertung bei Translokationsanalysen mit FISH;
e) die für die Bestimmung der Referenzdosis-Kennlinien verwendeten Kalibrierungsquellen und –dosis-bereiche, mit denen aus der chromosomalen Veränderungshäufigkeit und der Nachweisgrenze die Dosis eingeschätzt wird;
f) Bewertungsverfahren für die durch FISH angefärbten Translokationen zur Beurteilung der Strahlen-einwirkung;
g) Kriterien für die Umwandlung einer gemessenen Veränderungshäufigkeit in eine Energiedosis-einschätzung (auch als „Dosis“ bezeichnet);
h) Angabe der Ergebnisse;
i) Qualitätssicherung und Qualitätskontrolle;
j) Anhang A bis Anhang F mit Anweisungen zur Probeentnahme für den Kunden, Musterfragebogen, Musterdatenblatt zur Aufzeichnung der Veränderungen, Musterbericht und Anpassung der Niedrig-dosis-Wirkungs-Kurve anhand des Verfahrens der maximalen Wahrscheinlichkeit sowie Berechnung der Unsicherheit von Dosiseinschätzungen.

Radioprotection - Critères de performance pour les laboratoires utilisant l'analyse des translocations visualisées par hybridation in situ fluorescente (FISH) pour évaluer l'exposition aux rayonnements ionisants (ISO 20046:2019)

L'objectif du présent document est de fournir des critères pour l'assurance de la qualité (AQ), le contrôle de la qualité (CQ) et l'évaluation des performances des laboratoires de service pratiquant la dosimétrie biologique par cytogénétique.
Le présent document aborde:
a)    les responsabilités du demandeur et du laboratoire;
b)    la confidentialité des informations personnelles pour le demandeur et le laboratoire;
c)    les exigences de sécurité du laboratoire;
d)    le traitement des échantillons, la culture, la coloration et le dénombrement, y compris les critères de dénombrement pour l'analyse des translocations par FISH;
e)    les sources de calibration et les gammes de doses de calibration utiles pour établir les courbes dose-effet de référence qui contribuent à l'estimation dosimétrique à partir de la fréquence des aberrations chromosomiques et la limite de détection;
f)    la procédure de dénombrement des translocations colorées par FISH utilisée pour l'évaluation de l'exposition;
g)    les critères pour convertir une fréquence mesurée d'aberrations en une estimation de dose absorbée (également dénommée «estimation dosimétrique»);
h)    la présentation des résultats;
i)     l'AQ et le CQ;
j)     les Annexes A à F contenant des exemples d'instructions pour le traitement du prélèvement par le demandeur, de questionnaire, de tableau type pour le dénombrement des aberrations chromosomiques, de rapport et d'ajustement de la courbe dose-effet par la méthode du maximum de vraisemblance et de calcul de l'incertitude sur l'estimation de la dose absorbée.

Radiološka zaščita - Merila za delovanje laboratorijev, ki uporabljajo preskus translokacije fluorescenčne hibridizacije in-situ (FISH) za oceno izpostavljenosti ionizirnemu sevanju (ISO 20046:2019)

General Information

• Status: Published
• Publication Date: 09-Feb-2021
• Withdrawal Date: 30-Aug-2021
• ICS: 13.280 - Radiation protection
• 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: 10-Feb-2021
• Due Date: 22-Sep-2022
• Completion Date: 10-Feb-2021
• Ref Project: SIST EN ISO 20046:2021 - Radiological protection - Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation (ISO 20046:2019)

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2021
Radiološka zaščita - Merila za delovanje laboratorijev, ki uporabljajo preskus
translokacije fluorescenčne hibridizacije in-situ (FISH) za oceno izpostavljenosti
ionizirnemu sevanju (ISO 20046:2019)
Radiological protection - Performance criteria for laboratories using Fluorescence In Situ
Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation
(ISO 20046:2019)
Strahlenschutz - Leistungskriterien für Laboratorien, die den Fluoreszenz-in-situ-
Hybridisierungs-(FISH)-Translokationstest zur Bewertung der Exposition gegenüber
ionisierender Strahlung verwenden (ISO 20046:2019)
Radioprotection - Critères de performance pour les laboratoires utilisant l'analyse des
translocations visualisées par hybridation in situ fluorescente (FISH) pour évaluer
l'exposition aux rayonnements ionisants (ISO 20046:2019)
Ta slovenski standard je istoveten z: EN ISO 20046:2021
ICS:
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20046
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2021
EUROPÄISCHE NORM
ICS 13.280
English Version
Radiological protection - Performance criteria for
laboratories using Fluorescence In Situ Hybridization
(FISH) translocation assay for assessment of exposure to
ionizing radiation (ISO 20046:2019)
Radioprotection - Critères de performance pour les Strahlenschutz - Leistungskriterien für Laboratorien,
laboratoires utilisant l'analyse des translocations die den Fluoreszenz-in-situ-Hybridisierungs-(FISH)-
visualisées par hybridation in situ fluorescente (FISH) Translokationstest zur Bewertung der Exposition
pour évaluer l'exposition aux rayonnements ionisants gegenüber ionisierender Strahlung verwenden (ISO
(ISO 20046:2019) 20046:2019)
This European Standard was approved by CEN on 18 January 2021.

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, Turkey 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20046:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 20046:2019 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 20046:2021 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 August 2021, and conflicting national standards shall
be withdrawn at the latest by August 2021.
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.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 20046:2019 has been approved by CEN as EN ISO 20046:2021 without any modification.

INTERNATIONAL ISO
STANDARD 20046
First edition
2019-03
Radiological protection —
Performance criteria for laboratories
using Fluorescence In Situ
Hybridization (FISH) translocation
assay for assessment of exposure to
ionizing radiation
Radioprotection — Critères de performance pour les laboratoires
utilisant l'analyse des translocations visualisées par hybridation in
situ fluorescente (FISH) pour évaluer l'exposition aux rayonnements
ionisants
Reference number
ISO 20046:2019(E)
©
ISO 2019
ISO 20046:2019(E)
© ISO 2019
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]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 20046:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Translocation assay by FISH . 5
4.1 General . 5
4.2 Culturing and fixation . 5
4.3 Types of staining. 5
4.4 Scoring . . 6
4.5 General requirement of the laboratory . 6
5 Responsibility of the customer . 6
6 Responsibility of the laboratory . 7
6.1 Setup and sustainment of the QA program . 7
6.2 Responsibility during service . 7
7 Confidentiality of personal information . 8
7.1 Overview . 8
7.2 Applications of the principle of confidentiality . 8
7.2.1 Delegation of responsibilities within the laboratory. 8
7.2.2 Requests for analysis . 9
7.2.3 Transmission of confidential information . 9
7.2.4 Anonymity of samples . 9
7.2.5 Reporting of results . 9
7.2.6 Storage of data and results . 9
8 Laboratory safety requirements . 9
8.1 Overview . 9
8.2 Microbiological safety requirements .10
8.3 Chemical safety requirements .10
8.4 Optical safety requirements .11
8.5 Safety plan .11
9 Sample processing .11
9.1 Culturing and staining .11
9.2 Scoring . .12
9.2.1 Criteria for scoring .12
9.2.2 Conversion of translocation frequencies to genome equivalence .12
10 Background levels of translocations .13
11 Calibration curves .14
11.1 Calibration source(s) .14
11.2 Establishment of calibration curve(s) .14
12 Criteria for converting a measured aberration frequency into an estimate of
absorbed dose .16
12.1 Determination of estimated whole-body absorbed dose and confidence limits .16
12.1.1 General.
...