本文件提供了质量保证和质量控制、性能评估以及细胞遗传学服务实验室使用人工评分双中心测定进行生物剂量测定的认证标准。 本文件适用于 a） 对于请求者和服务实验室而言，个人信息的保密性， 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根据不稳定的染色体畸变频率和检测极限进行剂量估计， d） 用于生物剂量测定的不稳定染色体畸变的评分程序， 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，包含请求者的样本说明（见附录A）、样本问卷（见附录B）、样本报告（见附录C）、低剂量拟合- 最大似然法的响应曲线和剂量估计误差的计算（见附录D），疑似低剂量暴露病例的比值比法（见附录E），确定判定阈值和检测限的方法（见附录F）以及记录像差的样本数据表（见附录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).