ČSN P CEN/TS 17688-3 (857042)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA

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STANDARD published on 1.7.2022


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The information about the standard:

Designation standards: ČSN P CEN/TS 17688-3
Classification mark: 857042
Catalog number: 514609
Publication date standards: 1.7.2022
SKU: NS-1066250
The number of pages: 40
Approximate weight : 120 g (0.26 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

The category - similar standards:

In vitro diagnostic test systems

Annotation of standard text ČSN P CEN/TS 17688-3 (857042):

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

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