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

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

Status : Current   Published : January 2020

Format
PDF

Format
HARDCOPY



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
StatusCurrent
Publication Date24 January 2020
Normative References(Required to achieve compliance to this standard)EN ISO 15189:2012, ISO 15189:2012, ISO 15190
Informative References(Provided for Information)EN ISO/IEC 17020 (ISO/IEC 17020:2012) AS, ISO/IEC 17020:2012
International RelationshipsCEN/TS 17390-2:2020
DescriptorsLaboratories, Tumors, DNA, Specifications, Examination (medical)
ICS11.100.10
Title in FrenchAnalyses de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour les cellules tumorales circulantes (CTCs) dans le sang total veineux ADN extrait
Title in GermanMolekularanalytische in vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für zirkulierende Tumorzellen (CTC) in venösen Vollblutproben Isolierte DNA
CommitteeCH/212
ISBN978 0 539 12705 8
PublisherBSI
FormatA4
DeliveryYes
Pages30
File Size813 KB
Price£182.00


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