ISO 20046:2019 PDF

The purpose of ISO 20046:2019 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.