BS EN ISO 20186-3:2019 - Molecular in-vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free DNA from plasma

BS EN ISO 20186-3:2019

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

Status : Current   Published : October 2019

Format
PDF

Format
HARDCOPY



This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination 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. Different dedicated measures are taken for stabilizing blood genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2. Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document. NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes[8][9]. DNA in pathogens present in blood is not covered by this document.




Standard NumberBS EN ISO 20186-3:2019
TitleMolecular in-vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free DNA from plasma
StatusCurrent
Publication Date28 October 2019
Normative References(Required to achieve compliance to this standard)ISO 15189:2012
Informative References(Provided for Information)ISO/IEC 17020:2012, ISO 17511:2003, ISO/TS 17822-1:2014, ISO/IEC 17043:2010, ISO 15190:2003, ISO Guide 30:2015, ISO 20186-2:2019, ISO 9000:2015, ISO 22174:2005
ReplacesPD CEN/TS 16835-3:2015
International RelationshipsEN ISO 20186-3:2019,ISO 20186-3:2019
Amended ByCorrigendum, November 2019
DescriptorsLaboratories, Blood plasma, Quality management, Laboratory accreditation, Deoxyribonucleic acid, Laboratory testing, Quality assurance, Quality assurance systems, Cells (biology), Quality, Medical sciences, Medical laboratory equipment, Medical technology, Management
ICS11.100.10
11.100.30
Title in FrenchAnalyses de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques 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 DNA
CommitteeCH/212
ISBN978 0 539 12203 9
PublisherBSI
FormatA4
DeliveryYes
Pages26
File Size1.759 MB
Price£182.00


 Your basket
Your basket is empty

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


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


BSOL

The faster, easier way to work with standards


Develop a PAS

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