ČSN EN ISO 20046 (404316)

Die Annotation des Normtextes ČSN EN ISO 20046 (404316):

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) 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