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>UNE standards>UNE CEN/TS 17688-3:2021 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA (Endorsed by Asociación Española de Normalización in February of 2022.)
in stockReleased: 2022-02-01
UNE CEN/TS 17688-3:2021 - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA (Endorsed by Asociación Española de Normalización in February of 2022.)

UNE CEN/TS 17688-3:2021

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA (Endorsed by Asociación Española de Normalización in February of 2022.)

Análisis moleculares de diagnóstico in vitro. Especificaciones para los procesos preanalíticos para punciones con aguja fina (PAF). Parte 3: ADN genómico aislado. (Ratificada por la Asociación Española de Normalización en febrero de 2022.)

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Standard number:UNE CEN/TS 17688-3:2021
Pages:38
Released:2022-02-01
Status:Standard
DESCRIPTION

UNE CEN/TS 17688-3:2021

This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for gDNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine gDNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but EN ISO 20184-3, Molecular in vitro diagnostic examinations Specifications for pre-examination processes for frozen tissue Part 3: Isolated DNA and EN ISO 20166-3, Molecular in vitro diagnostic examinations Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue Part 3: Isolated DNA. This document is not applicable for pathogen DNA examination and gDNA examination by in situ detection. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.