BS EN ISO 20184-1:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated RNA

BS EN ISO 20184-1:2018

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

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 RNA examination 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 RNA extracted 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.

Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.




Standard NumberBS EN ISO 20184-1:2018
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated RNA
StatusCurrent
Publication Date19 December 2018
Normative References(Required to achieve compliance to this standard)ISO 15189:2012
Informative References(Provided for Information)ISO Guide 30:2015, ISO 22174:2005, ISO 17511:2003, ISO 9000:2015, ISO/IEC 17020, ISO 15190
ReplacesPD CEN/TS 16826-1:2015
International RelationshipsEN ISO 20184-1:2018,ISO 20184-1:2018
Draft Superseded By16/30326649 DC
DescriptorsMedical sciences, Histology, Nucleic acids, Ribonucleic acid, Medical technology, Medical inspection, Medical specimens, Laboratories
ICS11.100.10
Title in FrenchAnalyses de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour les tissus congelés ARN extrait
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für schockgefrorene Gewebeproben Isolierte RNS
CommitteeCH/212
ISBN978 0 580 90873 6
PublisherBSI
FormatA4
DeliveryYes
Pages28
File Size865 KB
Price£182.00


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