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ISO 17099:2014

(Main)

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

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

ISO 17099:2014 addresses the following: a) confidentiality of personal information for the customer and the laboratory; b) laboratory safety requirements; c) radiation sources, dose rates, and ranges used for establishing the calibration reference dose-effect curves allowing the dose estimation from CBMN assay yields and the minimum resolvable dose; d) performance of blood collection, culturing, harvesting, and sample preparation for CBMN assay scoring; e) scoring criteria; f) conversion of micronucleus frequency in binucleated cells into an estimate of absorbed dose; g) reporting of results; h) quality assurance and quality control; i) informative annexes containing examples of a questionnaire, instructions for customers, a microscope scoring data sheet, a sample report and advice on strengths and limitations of current automated systems for automated micronucleus scoring.

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

L'ISO 17099:2014 porte sur: a) la confidentialité des informations personnelles pour le demandeur et le laboratoire; b) les exigences de sécurité du laboratoire; c) les sources de rayonnements, les débits de doses et les gammes utilisées pour établir les courbes dose-effet d'étalonnage de référence qui permettent d'estimer les doses à partir des résultats du test des CBMN, ainsi que la dose minimum détectable; d) le prélèvement de sang, la mise en culture, le recueil des cellules après culture et la préparation des échantillons pour le test des CBMN; e) les critères de dénombrement; f) la conversion de la fréquence des micronoyaux dans les cellules binucléées en estimation de dose absorbée; g) la présentation des résultats; h) l'assurance et le contrôle de la qualité; i) les annexes informatives contenant des exemples de questionnaire, d'instructions d'utilisation, de tableau de dénombrement au microscope et de rapport, ainsi qu'une synthèse des avantages et limites des systèmes automatisés actuellement disponibles pour le dénombrement des micronoyaux.

General Information

Status
Withdrawn
Publication Date
05-Nov-2014
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
9599 - Withdrawal of International Standard
Completion Date
14-Jun-2024
Ref Project

Relations

Revised
ISO 17099:2024 - 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

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ISO 17099:2014 - Radiological protection — Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry Released:6. 11. 2014ISO 17099:2014 - Radiological protection — Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry Released:6. 11. 2014
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ISO 17099:2014 - Radiological protection -- Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetryISO 17099:2014 - Radiological protection -- Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
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ISO 17099:2014 - Radiological protection -- Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
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ISO 17099:2014 - 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 Released:15. 01. 2015ISO 17099:2014 - 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 Released:15. 01. 2015
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ISO 17099:2014 - 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 Released:15. 01. 2015
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ISO 17099:2014 - Radioprotection -- Criteres de performance pour les laboratoires pratiquant la dosimétrie biologique par le test des micronoyaux avec blocage de la cytodiérese (CBMN) dans les lymphocytes du sang périphériqueISO 17099:2014 - Radioprotection -- Criteres de performance pour les laboratoires pratiquant la dosimétrie biologique par le test des micronoyaux avec blocage de la cytodiérese (CBMN) dans les lymphocytes du sang périphérique
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ISO 17099:2014 - Radioprotection -- Criteres de performance pour les laboratoires pratiquant la dosimétrie biologique par le test des micronoyaux avec blocage de la cytodiérese (CBMN) dans les lymphocytes du sang périphérique
French language
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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 17099
First edition
2014-11-15
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 analyse des micronoyaux
par blocage de la cytokinèse (CBMN) dans les lymphocytes du sang
périphérique
Reference number
ISO 17099:2014(E)
©
ISO 2014

---------------------- Page: 1 ----------------------
ISO 17099:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 17099:2014(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Terms and definitions . 1
3 Micronucleus assay methodology used in this standard . 4
3.1 General . 4
3.2 General requirement of the laboratory . 4
3.3 Requests for analysis and blood sampling . 4
3.4 Cell culturing . 5
3.5 Staining . 5
3.6 Microscopy . 6
3.7 Visual scoring of slides . 6
3.8 Automated analysis . 7
4 Confidentiality of personal information . 7
4.1 Overview . 7
4.2 Applications of the principle of confidentiality . 7
5 Laboratory safety requirements . 8
5.1 Overview . 8
5.2 Microbiological safety requirements .
...

INTERNATIONAL ISO
STANDARD 17099
First edition
2014-11-15
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 analyse des micronoyaux
par blocage de la cytokinèse (CBMN) dans les lymphocytes du sang
périphérique
Reference number
ISO 17099:2014(E)
©
ISO 2014

---------------------- Page: 1 ----------------------
ISO 17099:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 17099:2014(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Terms and definitions . 1
3 Micronucleus assay methodology used in this standard . 4
3.1 General . 4
3.2 General requirement of the laboratory . 4
3.3 Requests for analysis and blood sampling . 4
3.4 Cell culturing . 5
3.5 Staining . 5
3.6 Microscopy . 6
3.7 Visual scoring of slides . 6
3.8 Automated analysis . 7
4 Confidentiality of personal information . 7
4.1 Overview . 7
4.2 Applications of the principle of confidentiality . 7
5 Laboratory safety requirements . 8
5.1 Overview . 8
5.2 Microbiological safety requirements .
...

NORME ISO
INTERNATIONALE 17099
Première édition
2014-11-15
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
Radiological protection — Performance criteria for laboratories
using the cytokinesis block micronucleus (CBMN) assay in peripheral
blood lymphocytes for biological dosimetry
Numéro de référence
ISO 17099:2014(F)
©
ISO 2014

---------------------- Page: 1 ----------------------
ISO 17099:2014(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2014
Droits de reproduction réservés. Sauf indication contraire, 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, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées 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 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Publié en Suisse
ii © ISO 2014 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 17099:2014(F)

Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Termes et définitions . 1
3 Méthodologie du test des micronoyaux . 4
3.1 Généralités . 4
3.2 Exigences générales relatives au laboratoire. 4
3.3 Demandes d’analyse et prélèvement de sang . 4
3.4 Culture des cellules . 5
3.5 Coloration . 6
3.6 Microscopie . 6
3.7 Dénombrement visuel des lames . 6
3.7.1 Généralités . 6
3.7.2 Critères de dénombrement . 6
3.7.3 Tableaux de dénombrement . 7
3.8 Analyse automatisée . 7
4 Confidentialité des informations personnelles . 7
4.1 Généralités . 7
4.2 Applications du principe de confidentialité .
...

NORME ISO
INTERNATIONALE 17099
Première édition
2014-11-15
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
Radiological protection — Performance criteria for laboratories
using the cytokinesis block micronucleus (CBMN) assay in peripheral
blood lymphocytes for biological dosimetry
Numéro de référence
ISO 17099:2014(F)
©
ISO 2014

---------------------- Page: 1 ----------------------
ISO 17099:2014(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2014
Droits de reproduction réservés. Sauf indication contraire, 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, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées 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 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Publié en Suisse
ii © ISO 2014 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 17099:2014(F)

Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Termes et définitions . 1
3 Méthodologie du test des micronoyaux . 4
3.1 Généralités . 4
3.2 Exigences générales relatives au laboratoire. 4
3.3 Demandes d’analyse et prélèvement de sang . 4
3.4 Culture des cellules . 5
3.5 Coloration . 6
3.6 Microscopie . 6
3.7 Dénombrement visuel des lames . 6
3.7.1 Généralités . 6
3.7.2 Critères de dénombrement . 6
3.7.3 Tableaux de dénombrement . 7
3.8 Analyse automatisée . 7
4 Confidentialité des informations personnelles . 7
4.1 Généralités . 7
4.2 Applications du principe de confidentialité .
...

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