Project No.ISO 20046:2019
Title<p>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.</p> <p>This document addresses:</p> <p>a) the responsibilities of both the customer and the laboratory;</p> <p>b) the confidentiality of personal information, for the customer and the laboratory;</p> <p>c) the laboratory safety requirements;</p> <p>d) sample processing; culturing, staining and scoring, including the criteria for scoring for translocation analysis by FISH;</p> <p>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;</p> <p>f) the scoring procedure for translocations stained by FISH used for evaluation of exposure;</p> <p>g) the criteria for converting a measured aberration frequency into an estimate of absorbed dose (also appears as "dose");</p> <p>h) the reporting of results;</p> <p>i) the QA and QC;</p> <p>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.</p>
Registration number (WIID)66892
Scope<p>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.</p> <p>This document addresses:</p> <p>a) the responsibilities of both the customer and the laboratory;</p> <p>b) the confidentiality of personal information, for the customer and the laboratory;</p> <p>c) the laboratory safety requirements;</p> <p>d) sample processing; culturing, staining and scoring, including the criteria for scoring for translocation analysis by FISH;</p> <p>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;</p> <p>f) the scoring procedure for translocations stained by FISH used for evaluation of exposure;</p> <p>g) the criteria for converting a measured aberration frequency into an estimate of absorbed dose (also appears as "dose");</p> <p>h) the reporting of results;</p> <p>i) the QA and QC;</p> <p>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.</p>
StatusStandarts spēkā
ICS group13.280