ISO 17099:2024

Description

This document gives guidance on

a)       confidentiality of personal information for the customer and the laboratory,

b)       laboratory safety requirements,

c)        calibration sources and calibration dose ranges useful for establishing the reference dose-response curves that contribute to the dose estimation from CBMN assay yields and the detection limit,

d)       performance of blood collection, culturing, harvesting, and sample preparation for CBMN assay scoring,

e)       scoring criteria,

f)         conversion of micronucleus frequency in BNCs into an estimate of absorbed dose,

g)       reporting of results,

h)       quality assurance and quality control, and

i)         informative annexes containing sample instructions for customers, sample questionnaire, a microscope scoring data sheet, and a sample report.

This document excludes methods for automated scoring of CBMN.