CEN/TS 17390-2:2020

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA

Publication date:   Aug 17, 2020

General information

60.60 Standard published   Jan 22, 2020

CEN

CEN/TC 140 In vitro diagnostic medical devices

Technical Specification

11.100.10   In vitro diagnostic test systems

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Scope

This document gives guidelines on the handling, storage, processing and documentation of venous blood
specimens intended for the examination of human genomic DNA isolated from Circulating Tumor Cells (CTCs) 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. 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.
This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom.
DNA in pathogens present in blood is not covered by this document.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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PUBLISHED
CEN/TS 17390-2:2020
60.60 Standard published
Jan 22, 2020