ISO 17099:2024

Radiological protection — Performance criteria for laboratories using the cytokinesis-block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry

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.

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

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.

General Information

• Status: Published
• Publication Date: 13-Jun-2024
• ICS: 13.280 - Radiation protection
• Technical Committee: ISO/TC 85/SC 2 - Radiological protection
• Drafting Committee: ISO/TC 85/SC 2 - Radiological protection
• Current Stage: 6060 - International Standard published
• Start Date: 14-Jun-2024
• Due Date: 29-Oct-2024
• Completion Date: 14-Jun-2024

Relations

• Consolidates: ISO 23256:2023 - Water quality — Detection of selected congeners of polychlorinated dibenzo-p-dioxins and polychlorinated biphenyls — Method using a flow immunosensor technique
• Effective Date: 06-Jun-2022
• Revises: ISO 17099:2014 - Radiological protection — Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
• Effective Date: 06-Jun-2022

Standards Content (Sample)

International
Standard
ISO 17099
Second edition
Radiological protection —
2024-06
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 l’analyse
des micronoyaux par blocage de la cytodiérèse (CBMN) dans les
lymphocytes du sang périphérique
Reference number
ISO 17099:2024(en) © ISO 2024

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ISO 17099:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
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

© ISO 2024 – All rights reserved
ii

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ISO 17099:2024(en)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 CMBN assay methodology used in this document . 3
4.1 General .3
4.2 Requests for analysis and blood sampling .3
5 Responsibility of the requestor . 3
6 Responsibility of the service laboratory . 4
6.1 Setup and sustainment of the quality assurance program .4
6.2 Responsibility during service .4
7 Confidentiality of personal information . 5
7.1 Overview .5
7.2 Applications of the principle of confidentiality .5
7.2.1 Delegation of responsibilities within the laboratory.5
7.2.2 Requests for analysis . .6
7.2.3 Transmission of confidential information .6
7.2.4 Anonymity of samples .
...

Norme
internationale
ISO 17099
Deuxième édition
Radioprotection — Critères de
2024-06
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
Radiological protection — Performance criteria for laboratories
using the cytokinesis-block micronucleus (CBMN) assay in
peripheral blood lymphocytes for biological dosimetry
Numéro de référence
ISO 17099:2024(fr) © ISO 2024

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ISO 17099:2024(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2024
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse

© ISO 2024 – Tous droits réservés
ii

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ISO 17099:2024(fr)
Sommaire Page
Avant-propos .v
Introduction .vii
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Méthodologie d’analyse des CBMN utilisée dans le présent document . 3
4.1 Généralités .3
4.2 Demandes d’analyse et prélèvement de sang .3
5 Responsabilité du demandeur . 4
6 Responsabilité du laboratoire . 4
6.1 Mise en place et maintenance du programme d’assurance qualité .4
6.2 Responsabilité pendant le service .5
7 Confidentialité des informations personnelles . 6
7.1 Vue d’ensemble .6
7.2 Applications du principe de confidentialité .6
7.2.1 Délégation de responsabilités au sein du laboratoire .6
7.2.2 Demandes d’analyses.6
7.2.3 Transmission d’informations confidentielles .6
7.2.4 Anonymat des échantillons.
...

FINAL DRAFT
International
Standard
ISO/FDIS 17099
ISO/TC 85/SC 2
Radiological protection —
Secretariat: AFNOR
Performance criteria for
Voting begins on:
laboratories using the cytokinesis
2024-03-28
block micronucleus (CBMN) assay
Voting terminates on:
in peripheral blood lymphocytes for
2024-05-23
biological dosimetry
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
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 17099:2024(en) © ISO 2024

---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 17099:2024(en)
International
Standard
ISO/FDIS 17099
ISO/TC 85/SC 2
Radiological protection —
Secretariat: AFNOR
Performance criteria for
Voting begins on:
laboratories using the cytokinesis
block micronucleus (CBMN) assay
Voting terminates on:
in peripheral blood lymphocytes for
biological dosimetry
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
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/FDIS 17099:2024(en) © ISO 2024

© ISO 2024 – All rights reserved
ii

---------------------- Page: 2 ----------------------
ISO/FDIS 17099:2024(en)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 CMBN assay methodology used in this document . 3
4.1 General .3
4.2 Requests for analysis and blood sampling .3
5 Responsibility of the requestor .
...

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ISO/FDIS 17099:2024(en)
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Date: 2024-02-26
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ISO /TC 85/SC 2/WG 18 .
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Secretariat: AFNOR
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Radiological protection — Performance criteria for laboratories
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using the cytokinesis- block micronucleus (CBMN) assay in
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peripheral blood lymphocytes for biological dosimetry
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Radioprotection — Critères de performance pour les laboratoires pratiquant la dosimétrie biologique par
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l’analyse des micronoyaux par blocage de la cytodiérèse (CBMN) dans les lymphocytes du sang périphérique
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ISO/FDIS 17099:2024(Een)
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© ISO 2024, Published in Switzerland
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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,
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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.
Commented [eXtyles2]: The reference "ISO 2024" is to a
withdrawn standard
ISO copyright office
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CP 401 • Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland Formatted: Default Paragraph Font
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© ISO 2024 – All rights reserved

ii

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ISO/FDIS 17099:2024(en)
Formatted: Font: 11 pt, Bold
Formatted: Font: Bold
Formatted: HeaderCentered, Left, Line spacing: single
Contents
Formatted: Adjust space between Latin and Asian text,
Adjust space between Asian text and numbers
Foreword . viii
Introduction . x
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 CMBN assay methodology used in this document . 3
4.1 General .
...