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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

Fecha:
2020-11 /Active
Equivalencias internacionales:

ISO 20046 (2019-03)

prEN ISO 20046 (2020-09)

Resumen:
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.
Keywords:
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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