PD CEN/TS 16835-1:2015 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated cellular RNA

PD CEN/TS 16835-1:2015

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated cellular RNA

Status : Superseded, Withdrawn   Published : July 2015 Replaced By : BS EN ISO 20186-1:2019

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This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for cellular RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). Blood cellular RNA profiles can change significantly after collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA analysis and storage. Different dedicated measures need to be taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this Technical Specification. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies. These are not described in this Technical Specification. RNA in pathogens present in blood is not covered by this Technical Specification.




Standard NumberPD CEN/TS 16835-1:2015
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated cellular RNA
StatusSuperseded, Withdrawn
Publication Date31 July 2015
Withdrawn Date02 April 2019
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 22174:2005, ISO 22174:2005
Replaced ByBS EN ISO 20186-1:2019
International RelationshipsCEN/TS 16835-1:2015
DescriptorsMedical sciences, Management, Quality assurance systems, Laboratory testing, Medical laboratory equipment, Medical technology, Laboratories, Quality management, Quality assurance, Laboratory accreditation, Quality
ICS11.100.10
Title in FrenchTests de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour le sang veineux total. ARN cellulaire isolé
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für venöse Vollblutproben. Isolierte zelluläre RNS
CommitteeCH/212
ISBN978 0 580 85028 8
PublisherBSI
FormatA4
DeliveryYes
Pages24
File Size530 KB
Price£182.00


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