NF EN ISO 19238

NF EN ISO 19238

September 2023
Standard Current

Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics - Dicentric assay

This document provides criteria for quality assurance and quality control, evaluation of the performance and the accreditation of biological dosimetry by cytogenetic service laboratories using the dicentric assay performed with manual scoring.This document is applicable toa)    the confidentiality of personal information, for the requestor and the service laboratory,b)    the laboratory safety requirements,c)    the calibration sources and calibration dose ranges useful for establishing the reference dose-response curves that contribute to the dose estimation from unstable chromosome aberration frequency and the detection limit,d)    the scoring procedure for unstable chromosome aberrations used for biological dosimetry,e)    the criteria for converting a measured aberration frequency into an estimate of absorbed dose,f)     the reporting of results,g)    the quality assurance and quality control, andh)    informative annexes containing sample instructions for requestor (see Annex A), sample questionnaire (see Annex B), sample report (see Annex C), fitting of the low dose-response curve by the method of maximum likelihood and calculating the error of the dose estimate (see Annex D), odds ratio method for cases of suspected exposure to a low dose (see Annex E), a method for determining the decision threshold and detection limit (see Annex F) and sample data sheet for recording aberrations (see Annex G).

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Main informations

Collections

National standards and national normative documents

Thematics

QSE, Gestion des risques et SST, Sécurité

Publication date

September 2023

Number of pages

55 p.

Reference

NF EN ISO 19238

ICS Codes

13.280   Radiation protection
17.240   Radiation measurements

Classification index

M60-220

Print number

1

International kinship

European kinship

EN ISO 19238:2023
Sumary
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics - Dicentric assay

This document provides criteria for quality assurance and quality control, evaluation of the performance and the accreditation of biological dosimetry by cytogenetic service laboratories using the dicentric assay performed with manual scoring.

This document is applicable to

a)    the confidentiality of personal information, for the requestor and the service laboratory,

b)    the laboratory safety requirements,

c)    the calibration sources and calibration dose ranges useful for establishing the reference dose-response curves that contribute to the dose estimation from unstable chromosome aberration frequency and the detection limit,

d)    the scoring procedure for unstable chromosome aberrations used for biological dosimetry,

e)    the criteria for converting a measured aberration frequency into an estimate of absorbed dose,

f)     the reporting of results,

g)    the quality assurance and quality control, and

h)    informative annexes containing sample instructions for requestor (see Annex A), sample questionnaire (see Annex B), sample report (see Annex C), fitting of the low dose-response curve by the method of maximum likelihood and calculating the error of the dose estimate (see Annex D), odds ratio method for cases of suspected exposure to a low dose (see Annex E), a method for determining the decision threshold and detection limit (see Annex F) and sample data sheet for recording aberrations (see Annex G).

Replaced standards (1)
NF EN ISO 19238
December 2017
Standard Cancelled
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics

ISO 19238:2014 provides criteria for quality assurance and quality control, evaluation of the performance, and the accreditation of biological dosimetry by cytogenetic service laboratories. ISO 19238:2014 addresses a) the confidentiality of personal information, for the customer and the service laboratory, b) the laboratory safety requirements, c) the calibration sources and calibration dose ranges useful for establishing the reference dose-effect curves that contribute to the dose estimation from chromosome aberration frequency and the minimum resolvable doses, d) the scoring procedure for unstable chromosome aberrations used for biological dosimetry, e) the criteria for converting a measured aberration frequency into an estimate of absorbed dose, f) the reporting of results, g) the quality assurance and quality control, h) informative annexes containing sample instructions for customer, sample questionnaire, sample of report, fitting of the low dose-response curve by the method of maximum likelihood and calculating the error of dose estimate, odds ratio method for cases of suspected exposure to a low dose, and sample data sheet for recording aberrations.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Abréviations
  • 5 Dénombrement des dicentriques
  • 6 Responsabilité du demandeur
  • 7 Responsabilité du laboratoire de service
  • 8 Confidentialité des informations personnelles
  • 9 Exigences de sécurité du laboratoire
  • 10 Traitement des échantillons
  • 11 Courbes d'étalonnage
  • 12 Critères pour convertir une fréquence d'aberration mesurée en une estimation de dose absorbée
  • 13 Présentation des résultats
  • 14 Assurance qualité et contrôle qualité
  • A Exemple d'instructions pour le demandeur
  • B Exemple de questionnaire
  • C Exemple de rapport
  • D Ajustement de la courbe dose-réponse à un rayonnement de faible TLE par la méthode du maximum de vraisemblanceet calcul de l'erreur d'estimation de dose
  • E Méthode de rapport de chances pour les cas d'exposition suspectéeà une faible dose de rayonnements ionisants
  • F Seuil de décision et limite de détection
  • G Tableau type pour le dénombrement des aberrations chromosomiques
  • Bibliographie
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