SNV - SN EN ISO 20046
Radiological protection - Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation
| Organization: | SNV |
| Publication Date: | 1 June 2021 |
| Status: | active |
| Page Count: | 52 |
| ICS Code (Radiation protection): | 13.280 |
scope:
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.
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