辐射防护用细胞遗传学进行生物剂量测定的服务实验室性能标准双中心测定

[中文适用范围]： 本文件提供了细胞遗传学服务实验室使用手工评分进行的双着丝粒分析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) 申请人和服务实验室的个人信息保密性；b) 实验室安全要求；c) 有助于根据不稳定染色体畸变频率和检测限估算剂量的参考剂量反应曲线建立校准源和校准剂量范围；d) 用于生物剂量测定的不稳定染色体畸变的评分程序；e) 将测量的畸变频率转换为吸收剂量估计值的标准；f) 结果报告；g) 质量保证和质量控制；h) 包含申请人样本说明（见附件 A）、样本问卷（见附件 B）、样本报告（见附件 C）、用最大似然法拟合低剂量反应曲线并计算剂量估计误差（见附件 D）、疑似低剂量暴露情况的优势比法（见附件 E）、确定决策阈值和检测限的方法（见附件 F）以及记录畸变的样本数据表（见附件G)。 [外文原描述]： 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 ).