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CEN

FprEN ISO 17099

(Main)

Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO/FDIS 17099:2024)

Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO/FDIS 17099:2024)

This document gives guidance on
a)       confidentiality of personal information for the customer and the laboratory,
b)       laboratory safety requirements,
c)        calibration sources and calibration dose ranges useful for establishing the reference dose-response curves that contribute to the dose estimation from CBMN assay yields and the detection limit,
d)       performance of blood collection, culturing, harvesting, and sample preparation for CBMN assay scoring,
e)       scoring criteria,
f)         conversion of micronucleus frequency in BNCs into an estimate of absorbed dose,
g)       reporting of results,
h)       quality assurance and quality control, and
i)         informative annexes containing sample instructions for customers, sample questionnaire, a microscope scoring data sheet, and a sample report.
This document excludes methods for automated scoring of CBMN.

Strahlenschutz - Leistungskriterien für Laboratorien, die den Zytokineseblock-Mikronukleustest (CBMN) in peripheren Blutlymphozyten für die biologische Dosimetrie verwenden (ISO/FDIS 17099:2024)

Dieses Dokument behandelt Folgendes:
a) die Vertraulichkeit von persönlichen Angaben, in Bezug auf Auftraggeber und Labor;
b) die Labor-Sicherheitsanforderungen;
c) die für die Bestimmung der Referenzdosis-Kennlinien verwendeten Kalibrierungsquellen und -dosisbe
reiche, mit denen aus den Ergebnissen des CBMN-Tests und der Nachweisgrenze die Dosis eingeschätzt wird;
d) die Durchführung der Blutentnahme, Kultivierung, Aufarbeitung und Probenpräparation für den CBMN- Test;
e) die Auswertekriterien;
f) die Abschätzung der absorbierten Dosis anhand der Häufigkeit von Mikrokernen in BNCs;
g) die Berichterstattung der Ergebnisse;
h) Qualitätssicherung und Qualitätskontrolle;
i) informative Anhänge mit Musteranweisungen für Auftraggeber, Musterfragebogen, Musterdatenblatt für die mikroskopische Auswertung und Musterbericht.

Radioprotection - Critères de performance pour les laboratoires pratiquant la dosimétrie biologique par l’analyse des micronoyaux par blocage de la cytodiérèse (CBMN) dans les lymphocytes du sang périphérique (ISO/FDIS 17099:2024)

Le présent document fournit des recommandations relatives:
a)       à la confidentialité des informations personnelles pour le demandeur et le laboratoire;
b)       aux exigences de sécurité relatives aux laboratoires;
c)        aux sources d’étalonnage et aux gammes de doses d’étalonnage utiles pour établir les courbes dose‑effet de référence qui contribuent à l’estimation de dose à partir des résultats de l’analyse des CBMN et à la limite de détection;
d)       au prélèvement, à la mise en culture, au recueil des cellules cultivées et à la préparation des échantillons de sang pour le dénombrement par analyse des CBMN;
e)       aux résultats de dénombrement;
f)         à la conversion de la fréquence des micronoyaux dans les BNC en estimation de dose absorbée;
g)       à la présentation des résultats;
h)       à l’assurance qualité et au contrôle qualité;
i)         aux annexes informatives contenant des exemples d’instructions d’utilisation, de questionnaire, de tableau de dénombrement au microscope et de rapport.
Le présent document exclut les méthodes de dénombrement automatisé des CBMN.

Radiološka zaščita - Merila za delovanje laboratorijev, ki za biološko dozimetrijo uporabljajo analizo tvorjenja mikrojeder s citokinetskim blokom (CBMN) v perifernih krvnih limfocitih (ISO/FDIS 17099:2024)

General Information

Status
Not Published
Publication Date
25-Jun-2024
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
5060 - Closure of Vote - Formal Approval
Start Date
23-May-2024
Completion Date
23-May-2024
Ref Project
kSIST FprEN ISO 17099:2024 - Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO/FDIS 17099:2024)

Relations

Revises
EN ISO 17099:2017 - Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO 17099:2014)
Effective Date
19-Jan-2023

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SLOVENSKI STANDARD
oSIST prEN ISO 17099:2023
01-november-2023
Nadomešča:
SIST EN ISO 17099:2017
Radiološka zaščita - Merila za delovanje laboratorijev, ki za biološko dozimetrijo
uporabljajo analizo tvorjenja mikrojeder s citokinetskim blokom (CBMN) v
perifernih krvnih limfocitih (ISO/DIS 17099:2023)
Radiological protection - Performance criteria for laboratories using the cytokinesis block
micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
(ISO/DIS 17099:2023)
Strahlenschutz - Leistungskriterien für Laboratorien, die den Zytokineseblock-
Mikronukleustest (CBMN) in peripheren Blutlymphozyten für die biologische Dosimetrie
verwenden (ISO/DIS 17099:2023)
Radioprotection - Critères de performance pour les laboratoires pratiquant la dosimétrie
biologique par l’analyse des micronoyaux par blocage de la cytodiérèse (CBMN) dans
les lymphocytes du sang périphérique (ISO/DIS 17099:2023)
Ta slovenski standard je istoveten z: prEN ISO 17099
ICS:
13.280 Varstvo pred sevanjem Radiation protection
oSIST prEN ISO 17099:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 17099:2023

---------------------- Page: 2 ----------------------
oSIST prEN ISO 17099:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 17099
ISO/TC 85/SC 2 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2023-08-28 2023-11-20
Radiological protection — Performance criteria for
laboratories using the cytokinesis block micronucleus
(CBMN) assay in peripheral blood lymphocytes for
biological dosimetry
Radioprotection — Critères de performance pour les laboratoires pratiquant la dosimétrie biologique par
le test des micronoyaux avec blocage de la cytodiérèse (CBMN) dans les lymphocytes du sang périphérique
ICS: 13.280
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 17099:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 3 ----------------------
oSIST prEN ISO 17099:2023
ISO/DIS 17099:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 17099
ISO/TC 85/SC 2 Secretariat: AFNOR
Voting begins on: Voting terminates on:

Radiological protection — Performance criteria for
laboratories using the cytokinesis block micronucleus
(CBMN) assay in peripheral blood lymphocytes for
biological dosimetry
Radioprotection — Critères de performance pour les laboratoires pratiquant la dosimétrie biologique par
le test des micronoyaux avec blocage de la cytodiérèse (CBMN) dans les lymphocytes du sang périphérique
ICS: 13.280
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 17099:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 4 ----------------------
oSIST prEN ISO 17099:2023
ISO/DIS 17099:2023(E)
Contents Page
Foreword .
...

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