PD CEN/TS 16835-3:2015 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free DNA from plasma

PD CEN/TS 16835-3:2015

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free DNA from plasma

Status : Superseded, Withdrawn   Published : October 2015 Replaced By : BS EN ISO 20186-3:2019

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This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) 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 ccfDNA profiles can change significantly after blood collection from the donor (e.g. release of genomic DNA from white blood cells, ccfDNA fragmentation and ccfDNA quantity change). Special measures need to be taken to secure good quality blood samples for ccfDNA analysis and storage. Different dedicated measures need to be taken for preserving blood genomic DNA. These are not described in this Technical Specification. Blood genomic DNA is covered in FprCEN/TS 16835-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA NOTE CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes [3] [4]. Pathogen DNA present in blood is not covered by this Technical Specification.




Standard NumberPD CEN/TS 16835-3:2015
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free DNA from plasma
StatusSuperseded, Withdrawn
Publication Date31 October 2015
Withdrawn Date28 October 2019
Normative References(Required to achieve compliance to this standard)EN ISO 15189:2012, ISO 15190, ISO 15189:2012
Informative References(Provided for Information)ISO Guide 30:2015, ISO 22174:2005, EN ISO 22174:2005, SRM 2372
Replaced ByBS EN ISO 20186-3:2019
International RelationshipsCEN/TS 16835-3:2015
DescriptorsQuality management, Medical technology, Medical sciences, Deoxyribonucleic acid, Medical laboratory equipment, Quality, Blood plasma, Laboratories, Laboratory testing, Quality assurance, Cells (biology), Laboratory accreditation, Quality assurance systems, Management
ICS11.100.30
Title in FrenchTests de diagnostic moléculaire in vitro. Spécifications relatives aux processus pré-analytiques pour le sang total veineux. ADN libre circulant extrait du plasma
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für venöse Vollblutproben. Aus Plasma isolierte zirkulierende zellfreie DNS
CommitteeCH/212
ISBN978 0 580 85027 1
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size1.143 MB
Price£130.00


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