BS EN ISO 20186-2:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated cellular RNA

BS EN ISO 20186-2:2019

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

Status : Current   Published : April 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination 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 cell free circulating DNA, which are not described in this document.

Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document.




Standard NumberBS EN ISO 20186-2:2019
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated genomic DNA
StatusCurrent
Publication Date02 April 2019
Normative References(Required to achieve compliance to this standard)ISO 15189:2012
Informative References(Provided for Information)ISO 20186-3, ISO 15190, ISO 9000:2015, ISO 18113-1:2009, ISO Guide 30:2015, ISO 17511:2003, ISO/IEC 17043:2010, ISO 22174:2005, ISO/TS 17822-1:2014
ReplacesPD CEN/TS 16835-2:2015
International RelationshipsEN ISO 20186-2:2019,ISO 20186-2:2019
Amended ByCorrigendum, May 2019
DescriptorsQuality assurance, Laboratories, Quality, Laboratory accreditation, Medical sciences, Medical laboratory equipment, Management, Deoxyribonucleic acid, Quality assurance systems, Laboratory testing, Quality management, Medical technology
ICS11.100.10
11.100.30
Title in FrenchAnalyses de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour le sang total veineux ARN cellulaire extrait
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für venöse Vollblutproben Isolierte genomische DNA
CommitteeCH/212
ISBN978 0 539 04949 7
PublisherBSI
FormatA4
DeliveryYes
Pages30
File Size648 KB
Price£182.00


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