PD CEN/TS 16827-1:2015 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue. Isolated RNA

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PD CEN/TS 16827-1:2015

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

Status : Superseded, Withdrawn   Published : August 2015 Replaced By : BS EN ISO 20166-1:2018

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This Technical Specification gives recommendations for the handling, documentation and processing of FFPE 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, developers and manufacturers of in vitro diagnostics, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). The formalin fixation and the paraffin embedding process lead to modifications of the RNA molecules, which can impact the validity and reliability of the analytical test results. Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis.




Standard NumberPD CEN/TS 16827-1:2015
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue. Isolated RNA
StatusSuperseded, Withdrawn
Publication Date31 August 2015
Withdrawn Date19 December 2018
Cross ReferencesEN ISO 15189:2012, ISO 15189:2012, ISO 15190, EN ISO 22174:2005, ISO 22174:2005, ISO Guide 30:1992
Replaced ByBS EN ISO 20166-1:2018
International RelationshipsCEN/TS 16827-1:2015
DescriptorsQuality, Quality assurance, Laboratory testing, Quality management, Management, Medical sciences, Laboratories, Medical technology, Laboratory accreditation, Medical laboratory equipment, Quality assurance systems
ICS11.100.10
Title in FrenchTests de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour les tissus FFPE. ARN extrait
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für FFPEGewebeproben. Isolierte RNS
CommitteeCH/212
ISBN978 0 580 85029 5
PublisherBSI
FormatA4
DeliveryYes
Pages24
File Size507 KB
Price£182.00


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