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
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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