EN ISO 17099:2024
(Main)Radiological protection - Performance criteria for laboratories using the cytokinesis-block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO 17099:2024)
Radiological protection - Performance criteria for laboratories using the cytokinesis-block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO 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 Zytokinese-Block-Mikrokerntest (CBMN) in peripheren Blutlymphozyten für die biologische Dosimetrie verwenden (ISO 17099:2024)
Dieses Dokument behandelt Folgendes:
a) die Vertraulichkeit von persönlichen Angaben, in Bezug auf Auftraggeber und Laboratorium;
b) die Labor-Sicherheitsanforderungen;
c) die für die Bestimmung der Referenz-Dosis-Effekt-Kurven verwendeten Kalibrierungsquellen und dosisbereiche, mit denen aus den Ergebnissen des CBMN-Tests und der Nachweisgrenze die Dosis geschätzt 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, und
i) informative Anhänge mit Musteranweisungen für Auftraggeber, Musterfragebogen, Musterdatenblatt für die mikroskopische Auswertung und Musterbericht.
Dieses Dokument schließt Verfahren zur automatischen Bewertung von CBMN aus.
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 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 17099:2024)
Ta dokument podaja smernice za
a) zaupnost osebnih podatkov stranke in laboratorija,
b) zahteve za varnost laboratorija,
c) vire umerjanja in razpone odmerkov umerjanja, ki so koristni za določanje referenčnih krivulj odziva odmerka ter omogočajo ocenjevanje odmerka na podlagi rezultatov analize tvorjenja mikrojeder s citokinetskim blokom (CBMN) in meje zaznavnosti,
d) učinkovitost zbiranja krvi ter gojenja, zajemanja in priprave vzorcev za ocenjevanje rezultatov analize tvorjenja mikrojeder s citokinetskim blokom,
e) kriterije ocenjevanja,
f) pretvorbo pogostosti mikrojeder v dvojedrnih celicah (BNC) v približek absorbiranega odmerka,
g) poročanje rezultatov,
h) zagotavljanje in nadzor kakovosti ter
i) informativne dodatke, ki vsebujejo vzorčna navodila za stranke, vzorčni vprašalnik, tehnični list za ocenjevanje pri opazovanju z mikroskopom in vzorčno poročilo.
Ta dokument ne zajema metod za avtomatizirano ocenjevanje tvorjenja mikrojeder s citokinetskim blokom.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2024
Radiološka zaščita - Merila za delovanje laboratorijev, ki za biološko dozimetrijo
uporabljajo analizo tvorjenja mikrojeder s citokinetskim blokom (CBMN) v
perifernih krvnih limfocitih (ISO 17099:2024)
Radiological protection - Performance criteria for laboratories using the cytokinesis block
micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
(ISO 17099:2024)
Strahlenschutz - Leistungskriterien für Laboratorien, die den Zytokineseblock-
Mikronukleustest (CBMN) in peripheren Blutlymphozyten für die biologische Dosimetrie
verwenden (ISO 17099:2024)
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 17099:2024)
Ta slovenski standard je istoveten z: EN ISO 17099:2024
ICS:
13.280 Varstvo pred sevanjem Radiation protection
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 17099
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2024
EUROPÄISCHE NORM
ICS 13.280 Supersedes EN ISO 17099:2017
English Version
Radiological protection - Performance criteria for
laboratories using the cytokinesis-block micronucleus
(CBMN) assay in peripheral blood lymphocytes for
biological dosimetry (ISO 17099:2024)
Radioprotection - Critères de performance pour les Strahlenschutz - Leistungskriterien für Laboratorien,
laboratoires pratiquant la dosimétrie biologique par die den Zytokineseblock-Mikronukleustest (CBMN) in
l'analyse des micronoyaux par blocage de la peripheren Blutlymphozyten für die biologische
cytodiérèse (CBMN) dans les lymphocytes du sang Dosimetrie verwenden (ISO 17099:2024)
périphérique (ISO 17099:2024)
This European Standard was approved by CEN on 24 June 2024.
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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17099:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 17099:2024) 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 December 2024, and conflicting national standards
shall be withdrawn at the latest by December 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 17099:2017.
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 17099:2024 has been approved by CEN as EN ISO 17099:2024 without any modification.
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
ISO 17099:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
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 .6
7.2.5 Reporting of results .6
7.2.6 Storage .6
7.2.7 Data security plan .6
8 Laboratory safety requirements . 6
8.1 Overview .6
8.2 Microbiological safety requirements .7
8.3 Chemical safety requirements .7
8.4 Optical safety requirements .8
8.5 Safety plan .8
9 Sample processing. 8
9.1 Culturing .8
9.2 Staining .10
9.3 Microscopy .10
9.4 Scoring of slides .10
9.4.1 General .10
9.4.2 Criteria for scoring .10
9.4.3 Scoring data sheets .11
9.5 Automated analysis .11
10 Calibration source(s), calibration curve, and minimum detectable dose.11
10.1 Calibration source(s) .
...
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