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Homepage>CSN Standards>85 HEALTH SERVICE>8570 Diagnostic systems in vitro>CSN 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
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Released: 01.07.2019
CSN 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

CSN 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

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Number of Standard:CSN EN ISO 20166-3
Category:857032
Pages:32
Released:01.07.2019
Catalog number:507449
DESCRIPTION

CSN EN ISO 20166-3

CSN EN ISO 20166-3 This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. NOTE: International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.