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Technische Regel
ONR CEN/TS 17688-3
Issue date: 2022 02 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA
This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for gDNA examination during the pre-examina...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 39 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
ONR CEN/TS 17688-3
2022 02 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine N...
Technische Regel
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ONR CEN/TS 17688-3
2021 09 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine N...
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