NF EN ISO 19238, M60-220 (09/2023)

This document provides criteria for quality assurance and quality control, performance evaluation and accreditation of service laboratories performing cytogenetic biological dosimetry via manual dicentric enumeration. This document applies to a) confidentiality of personal information for the applicant and the service laboratory, b) laboratory security requirements, c) calibration sources and calibration dose ranges useful for establishing the reference dose-response curves which contribute to the dose estimation based on the frequency of unstable chromosomal aberrations, and the limit of detection, d) the procedure for counting unstable chromosomal aberrations used for biological dosimetry, e) the criteria for converting a measured frequency of aberrations into an estimate of absorbed dose, f) presentation of results, g) quality assurance and quality control, and h) informative annexes containing examples: of instructions for the applicant (see Appendix A), questionnaire (see Appendix B), report (see Appendix C), adjustment of the dose-response curve at low doses using the maximum likelihood method and taking into account the error of dose estimation (see Appendix D), odds ratio method for cases of suspected exposure to a low dose (see Appendix E), method for determining the decision threshold and detection limit (see Appendix F) and a standard table for enumerating chromosomal aberrations (see Appendix G).
(Automatic translation from French)