BS EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated cellular RNA

BS EN ISO 20186-1:2019

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

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 cellular RNA 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 RNA and RNA in exosomes circulating in blood. These 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.

This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom.

RNA in pathogens present in blood is not covered by this document.




Standard NumberBS EN ISO 20186-1:2019
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated cellular RNA
StatusCurrent
Publication Date02 April 2019
Normative References(Required to achieve compliance to this standard)ISO 15189:2012
Informative References(Provided for Information)ISO 15190, ISO Guide 30:2015, ISO/TS 17822-1:2014, ISO 18113-1:2009, ISO/IEC 17020:2012, ISO/IEC 17043:2010, ISO 9000:2015, ISO 22174:2005, ISO 17511:2003
ReplacesPD CEN/TS 16835-1:2015
International RelationshipsEN ISO 20186-1:2019,ISO 20186-1:2019
Draft Superseded By17/30326658 DC
DescriptorsQuality assurance systems, Quality, Laboratory testing, Medical sciences, Quality management, Laboratories, Medical technology, Quality assurance, Management, Medical laboratory equipment, Laboratory accreditation
ICS11.100.10
Title in FrenchAnalyses de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour le sang total veineux RN cellulaire extrait
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für venöse Vollblutproben Isolierte zelluläre RNA
CommitteeCH/212
ISBN978 0 580 90876 7
PublisherBSI
FormatA4
DeliveryYes
Pages30
File Size742 KB
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


Tracked Changes

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


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


BSOL

The faster, easier way to work with standards