ISO 20046:2019 放射防护 使用荧光原位杂交（FISH）易位试验评估电离辐射暴露的实验室性能标准

标准编号：ISO 20046:2019

中文名称：放射防护 使用荧光原位杂交（FISH）易位试验评估电离辐射暴露的实验室性能标准

英文名称：Radiological protection — Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation

发布日期：2019-03

标准范围

The purpose of this document is to provide criteria for quality assurance (QA), quality control (QC) and 
evaluation of the performance of biological dosimetry by cytogenetic service laboratories.
This document addresses:
a) the responsibilities of both the customer and the laboratory;
b) the confidentiality of personal information, for the customer and the laboratory;
c) the laboratory safety requirements;
d) sample processing; culturing, staining and scoring, including the criteria for scoring for 
translocation analysis by FISH;
e) the calibration sources and calibration dose ranges useful for establishing the reference 
dose-response curves that contribute to the dose estimation from chromosome aberration 
frequency and the detection limit;
f) the scoring procedure for translocations stained by FISH used for evaluation of exposure;
g) the criteria for converting a measured aberration frequency into an estimate of absorbed dose 
(also appears as “dose”);
h) the reporting of results;
i) the QA and QC;
j) Annexes A to F containing sample instructions for the customer, sample questionnaire, sample 
datasheet for recording aberrations, sample of report and fitting of the low dose-response curve by 
the method of maximum likelihood and calculating the uncertainty of dose estimate.

标准预览图