PD CEN/TS 16826-1:2015 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated RNA

PD CEN/TS 16826-1:2015

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

Status : Superseded, Withdrawn   Published : August 2015 Replaced By : BS EN ISO 20184-1:2018

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This Technical Specification recommends the handling, documentation and processing of frozen tissue specimens intended for RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g., in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities). RNA profiles in tissues can change significantly before and after collection and can change differently in different donors’ / patients’ tissues. Therefore, special measures have to be taken to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis. Tissues that have undergone chemical stabilisation pre-treatment before freezing are not covered in this document.




Standard NumberPD CEN/TS 16826-1:2015
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated RNA
StatusSuperseded, Withdrawn
Publication Date31 August 2015
Withdrawn Date19 December 2018
Normative References(Required to achieve compliance to this standard)ISO 15190, EN ISO 15189:2012, ISO 15189:2012
Informative References(Provided for Information)EN ISO 22174:2005, ISO Guide 30:1992, ISO 22174:2005
Replaced ByBS EN ISO 20184-1:2018
International RelationshipsCEN/TS 16826-1:2015
DescriptorsMedical inspection, Histology, Medical specimens, Nucleic acids, Medical sciences, Ribonucleic acid, Medical technology, Laboratories
ICS11.100.10
Title in FrenchTests de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour les tissus à congélation rapide. ARN extrait
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für schockgefrorene Gewebeproben. Isolierte RNS
CommitteeCH/212
ISBN978 0 580 85026 4
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size565 KB
Price£130.00


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