PD CEN/TS 17390-1:2020 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Isolated RNA

PD CEN/TS 17390-1:2020

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Isolated RNA

Status : Current   Published : January 2020

Format
PDF

Format
HARDCOPY



This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human cellular RNA 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 cellular RNA directly from venous whole blood containing CTCs. This is covered in EN ISO 20186-1. This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom. RNA 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 17390-1:2020
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Isolated RNA
StatusCurrent
Publication Date24 January 2020
Normative References(Required to achieve compliance to this standard)EN ISO 15189:2012, ISO 15189:2012
Informative References(Provided for Information)EN ISO/IEC 17020 (ISO/IEC 17020:2012) AS, ISO/IEC 17020:2012, CEN/TS 17390-3
International RelationshipsCEN/TS 17390-1:2020
DescriptorsRNA, Specifications, Blood, Examination (medical), Diagnostic testing
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 ARN extrait
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für zirkulierende Tumorzellen (CTC) in venösen Vollblutproben Isolierte RNA
CommitteeCH/212
ISBN978 0 539 12704 1
PublisherBSI
FormatA4
DeliveryYes
Pages28
File Size792 KB
Price£182.00


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