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CEN

EN ISO 17099:2017

(Main)

Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO 17099:2014)

Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO 17099:2014)

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.

Strahlenschutz - Durchführungskriterien für Laboratorien für die Anwendung des zytokinese-geblockten Mikrokerntests (cytokinesis-blocked micronucleus, CBMN) in Lymphozyten des menschlichen peripheren Blutes im Rahmen der biologischen Dosimetrie (ISO 17099:2014)

Diese Internationale Norm behandelt Folgendes:
a)   die Vertraulichkeit von persönlichen Angaben in Bezug auf den Kunden und das Laboratorium;
b)   Labor-Sicherheitsanforderungen;
c)   Strahlungsquellen, Dosisleistungen und -bereiche, die für die Erstellung der Referenz-Dosis-Wirkungs-Kurven für die Kalibrierung verwendet werden, die eine Schätzung der Dosis aus Ausbeuten des CBMN-Tests und der kleinsten auflösbaren Dosis ermöglichen;
d)   Durchführung von Blutentnahme, Kultivierung, Ernte und Probenvorbereitung für die Bewertung mittels CBMN-Test;
e)   Bewertungskriterien;
f)   Umwandlung der Häufigkeit von Kleinkernen in zweikernigen Zellen in einen Schätzwert der absorbierten Dosis;
g)   Berichterstattung der Ergebnisse;
h)   Qualitätssicherung und Qualitätsteuerung;
i)   informative Anhänge, die Beispiele für einen Fragebogen, Anweisungen für Kunden, ein Datenblatt für die mikroskopische Bewertung, einen Musterbericht und Hinweise zu Stärken und Grenzen von derzeitigen automatisierten Systemen für die automatisierte Bewertung von Kleinkernen enthalten.

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 (ISO 17099:2014)

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.

Radiološka zaščita - Merila za delovanje laboratorijev, ki za biološko dozimetrijo uporabljajo analizo tvorjenja mikrojeder s citokinetskim blokom v perifernih krvnih limfocitih (ISO 17099:2014)

Standard ISO 17099:2014 obravnava:
a) zaupnost osebnih podatkov stranke in laboratorija;
b) varnostne zahteve laboratorija;
c) vire sevanja, hitrosti odmerka in razpone, ki se uporabljajo za določanje referenčnih krivulj učinkov odmerka za umerjanje ter omogočajo ocenjevanje odmerka na podlagi rezultatov preizkusov CBMN in minimalnega razločljivega odmerka;
d) učinkovitost zbiranja krvi ter gojenja, zajemanja in pripravo vzorcev za ocenjevanje rezultatov preizkusov CBMN;
e) merila ocenjevanja;
f) pretvorbo pogostosti mikrojeder v dvojedrnih celicah v približek absorbiranega odmerka;
g) poročanje rezultatov;
h) zagotavljanje in nadzor kakovosti;
i) informativne dodatke, ki vsebujejo primere vprašalnika, navodil za stranke, tehničnega lista za ocenjevanje pri opazovanju z mikroskopom, vzorčnega poročila ter nasvet o prednostih in omejitvah trenutnih avtomatiziranih sistemov za ocenjevanje mikrojeder.

General Information

Status
Published
Publication Date
10-Oct-2017
Withdrawal Date
29-Apr-2018
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
11-Oct-2017
Due Date
05-May-2019
Completion Date
11-Oct-2017
Ref Project
SIST 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)

Relations

Revised
FprEN ISO 17099 - Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO/FDIS 17099:2024)
Effective Date
19-Jan-2023

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SLOVENSKI STANDARD
SIST EN ISO 17099:2017
01-december-2017
5DGLRORãND]DãþLWD0HULOD]DGHORYDQMHODERUDWRULMHYNL]DELRORãNRGR]LPHWULMR
XSRUDEOMDMRDQDOL]RWYRUMHQMDPLNURMHGHUVFLWRNLQHWVNLPEORNRPYSHULIHUQLKNUYQLK
OLPIRFLWLK ,62
Radiological protection - Performance criteria for laboratories using the cytokinesis block
micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
(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 (ISO 17099:2014)
Ta slovenski standard je istoveten z: EN ISO 17099:2017
ICS:
13.280 Varstvo pred sevanjem Radiation protection
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
SIST EN ISO 17099:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 17099:2017

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SIST EN ISO 17099:2017


EN ISO 17099
EUROPEAN STANDARD

NORME EUROPÉENNE

October 2017
EUROPÄISCHE NORM
ICS 13.280
English Version

Radiological protection - Performance criteria for
laboratories using the cytokinesis block micronucleus
(CBMN) assay in peripheral blood lymphocytes for
biological dosimetry (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
(ISO 17099:2014)
This European Standard was approved by CEN on 13 September 2017.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17099:2017 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 17099:2017
EN ISO 17099:2017 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 17099:2017
EN ISO 17099:2017 (E)
European foreword
The text of ISO 17099:2014 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 17099:2017 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 April 2018, and conflicting national standards shall be
withdrawn at the latest by April 2018.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
...

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