Alcance
ISO 17099:2014 addresses the following:a) confidentiality of personal information for the customer and the laboratory;b) laboratory safety requirements;c) radiation sources, dose rates, and ranges used for establishing the calibration reference dose-effect curves allowing the dose estimation from CBMN assay yields and the minimum resolvable dose;d) performance of blood collection, culturing, harvesting, and sample preparation for CBMN assay scoring;e) scoring criteria;f) conversion of micronucleus frequency in binucleated cells into an estimate of absorbed dose;g) reporting of results;h) quality assurance and quality control;i) informative annexes containing examples of a questionnaire, instructions for customers, a microscope scoring data sheet, a sample report and advice on strengths and limitations of current automated systems for automated micronucleus scoring.