PD CEN/TS 16827-3:2015 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue. Isolated DNA

PD CEN/TS 16827-3:2015

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

Status : Superseded, Withdrawn   Published : August 2015 Replaced By : BS EN ISO 20166-3:2019

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This Technical Specification gives recommendations for the handling, documentation and processing of FFPE tissue specimens intended for DNA 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). DNA integrity in tissues can change before and during formalin fixation, processing and storage. Chemical modifications introduced into DNA during tissue fixation might lead to fragmentation and sequence alterations [1], changes in the methylation status or even structural changes which can lead to e.g., spurious copy number changes in array-CGH profiles [2]. These modifications of the DNA molecules can impact the validity and reliability of the analytical test results. Therefore, it is essential to take special measures to minimize the described modifications for subsequent DNA analysis.




Standard NumberPD CEN/TS 16827-3:2015
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue. Isolated DNA
StatusSuperseded, Withdrawn
Publication Date31 August 2015
Withdrawn Date28 January 2019
Normative References(Required to achieve compliance to this standard)EN ISO 15189:2012, ISO 15189:2012, ISO 15190
Informative References(Provided for Information)EN ISO 22174:2005, ISO Guide 30:1992, ISO 22174:2005
Replaced ByBS EN ISO 20166-3:2019
International RelationshipsCEN/TS 16827-3:2015
DescriptorsMedical technology, Laboratories, Laboratory testing, Quality assurance systems, Quality, Management, Quality management, Medical sciences, Medical laboratory equipment, Laboratory accreditation, Quality assurance
ICS11.100.10
Title in FrenchTests de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour les tissus FFPE.ADN isolé
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für FFPEGewebeproben. Isolierte DNS
CommitteeCH/212
ISBN978 0 580 85032 5
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size1.055 MB
Price£130.00


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