PD CEN/TS 16835-2:2015 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated genomic DNA

PD CEN/TS 16835-2:2015

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

Status : Withdrawn, Superseded   Published : October 2015 Replaced By : BS EN ISO 20186-2:2019

WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001


This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for genomic DNA 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 genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysis. This is particularly relevant for analytical test procedures requiring high molecular weight DNA. Different dedicated measures need to be taken for preserving blood cell free circulating DNA, which are not described in this Technical Specification. Circulating cell free DNA in blood is covered in CEN/TS 16835-3, Molecular in vitro diagnostic examinations -Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for blood collected and stored by paper based technologies. These are not described in this Technical Specification. Pathogen DNA present in blood is not covered by this Technical Specification.




Standard NumberPD CEN/TS 16835-2:2015
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated genomic DNA
StatusWithdrawn, Superseded
Publication Date31 October 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Withdrawn Date02 April 2019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)ISO Guide 30:2015, ISO 22174:2005, EN ISO 22174:2005
Replaced ByBS EN ISO 20186-2:2019
International RelationshipsCEN/TS 16835-2:2015
DescriptorsQuality management, Medical technology, Laboratory accreditation, Quality, Quality assurance, Quality assurance systems, Management, Laboratories, Laboratory testing, Medical sciences, Deoxyribonucleic acid, Medical laboratory equipment
ICS11.100.30
Title in FrenchTests de diagnostic moléculaire in vitro. Spécifications relatives aux processus pré-analytiques pour le sang total veineux. ADN génomique extrait
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für venöse Vollblutproben. Isolierte genomische DNS
CommitteeCH/212
ISBN978 0 580 85033 2
PublisherBSI
FormatA4
DeliveryYes
Pages26
File Size1.54 MB
Price£182.00


WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001
 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Develop a PAS

Develop a fast-track standardization document in 9-12 months


Worldwide Standards
We can source any standard from anywhere in the world