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Normas DIN – AENOR
DIN EN ISO 20046:2020-11

DIN EN ISO 20046:2020-11

Radiological protection - Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation (ISO 20046:2019); German and English version prEN ISO 20046:2020 / Note: Date of issue 2020-10-02

Radioprotection - Critères de performance pour les laboratoires utilisant l'analyse des translocations visualisées par hybridation in situ fluorescente (FISH) pour évaluer l'exposition aux rayonnements ionisants (ISO 20046:2019); Version allemande et anglaise prEN ISO 20046:2020 / Attention: Date de parution 2020-10-02

Strahlenschutz - Leistungskriterien für Laboratorien, die den Fluoreszenz-in-situ-Hybridisierungs-(FISH)-Translokationstest zur Bewertung der Exposition gegenüber ionisierender Strahlung verwenden (ISO 20046:2019); Deutsche und Englische Fassung prEN ISO 20046:2020 / Achtung: Erscheinungsdatum 2020-10-02

2020-11 /Active
Equivalencias internacionales:

ISO 20046 (2019-03)

prEN ISO 20046 (2020-09)

The 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) 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.
Accreditation, Calibration, Competence, Cytology, Definitions, Diagnosis, Dosimetry, Evaluations, Exposure, Fluorescence, In situ, Ionizing radiation, Laboratories, Personnel, Quality assurance, Quality control, Quality management, Radiation exposure, Radiation protection, Sampling methods, Specification (approval), Test laboratories
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