ISO 19238:2023 辐射防护 用细胞遗传学实行生物剂量测定的工作实验室的性能准则 双中心测定

标准编号：ISO 19238:2023

中文名称：辐射防护 用细胞遗传学实行生物剂量测定的工作实验室的性能准则 双中心测定

英文名称：Radiological protection — Performance criteria for service laboratories performing biological dosimetry by cytogenetics — Dicentric assay

发布日期：2023-08

标准范围

本文件提供了细胞遗传学服务实验室使用手动评分的双中心试验进行生物剂量测定的质量保证和质量控制、性能评估和认证的标准。本文件适用于A）？个人信息的保密性，对于请求者和服务实验室来说，b）？实验室安全要求，c）？用于建立参考剂量-反应曲线的校准源和校准剂量范围有助于从不稳定染色体畸变频率和检测限进行剂量估计，d）？用于生物剂量测定的不稳定染色体畸变评分程序，e）？用于将测量的像差频率转换为吸收剂量的估计的标准，(f)？结果的报告，(g)？质量保证和质量控制，以及(h)？资料性附件，包括申请人须知样本（见附件？A）、问卷样本（见附件？B）、报告样本（见附件？C）、用最大似然法拟合低剂量反应曲线和计算剂量估计误差（见附件？D）、疑似低剂量暴露病例的比值比法（见附件？E）、确定决定阈值和检测限的方法（见附件？F）和记录偏差的样本数据表（见附件？G）。

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).

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