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  • BSI
    PD CEN/TS 17390-2:2020 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Isolated DNA
    Edition: 2020
    $435.35
    / user per year

Description of PD CEN/TS 17390-2:2020 2020

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.

Standard NumberPD CEN/TS 17390-2:2020
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Isolated DNA
StatusDefinitive
Publication Date2020-01-24
Identical National Standard OfCEN/TS 17390-2:2020
DescriptorsExamination (medical), Specifications, DNA, Tumors, Laboratories
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 539 12705 8
PublisherBSI
Pages30

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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