BS EN ISO 20184-2:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated proteins

BS EN ISO 20184-2:2018

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated proteins

Status : Current   Published : December 2018

Format
PDF

Format
HARDCOPY



What is this standard about?

This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed.

This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate proteins isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.




Standard NumberBS EN ISO 20184-2:2018
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated proteins
StatusCurrent
Publication Date12 December 2018
Normative References(Required to achieve compliance to this standard)ISO 15189:2012
Informative References(Provided for Information)ISO 15190, ISO/IEC 17020:2012, ISO GUIDE 30:1992, ISO 9000:2005, ISO 17511:2003
ReplacesPD CEN/TS 16826-2:2015
International RelationshipsEN ISO 20184-2:2018,ISO 20184-2:2018
Amended ByCorrigendum, February 2019
DescriptorsQuality assurance, Laboratory accreditation, Quality assurance systems, Medical technology, Management, Laboratory testing, Medical laboratory equipment, Quality, Quality management, Medical sciences, Laboratories
ICS11.100.10
Title in FrenchAnalyses de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour les tissus congelés Protéines extraites
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für schockgefrorene Gewebeproben Isolierte Proteine
CommitteeCH/212
ISBN978 0 539 04042 5
PublisherBSI
FormatA4
DeliveryYes
Pages26
File Size809 KB
Price£182.00


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