PD CEN/TS 17390-3:2020 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Preparations for analytical CTC staining

PD CEN/TS 17390-3:2020

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Preparations for analytical CTC staining

Status : Current   Published : January 2020

Format
PDF

Format
HARDCOPY



This document gives guidelines on the handling, storage, processing and documentation of venous whole blood and the CTC (Circulating Tumor Cell) enrichment, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical staining) of CTCs during the pre-examination Phase before the cytopathological evaluation 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 specific staining procedures. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.




Standard NumberPD CEN/TS 17390-3:2020
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Preparations for analytical CTC staining
StatusCurrent
Publication Date24 January 2020
Normative References(Required to achieve compliance to this standard)ISO 15189:2012, EN ISO 15189:2012, ISO 15190
Informative References(Provided for Information)ISO/IEC 17020:2012, EN ISO/IEC 17020 (ISO/IEC 17020:2012) AS
International RelationshipsCEN/TS 17390-3:2020
DescriptorsPreparation, Blood, Tumors, Specifications, Examination (medical)
ICS11.100.10
Title in FrenchAnalyses de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour les cellules tumorales circulantes (CTC) du sang total veineux Préparations pour l'analyse par coloration des CTC
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für zirkulierende Tumorzellen (CTC) in venösen Vollblutproben Vorbereitungen für die analytische CTC-Färbung
CommitteeCH/212
ISBN978 0 539 12706 5
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size735 KB
Price£130.00


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