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Technische Regel
ONR CEN/TS 16827-3
Issue date: 2015 11 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3: Isolated DNA (CEN/TS 16827-3:2015)
This Technical Specification gives recommendations for the handling, documentation and processing of FFPE tissue specimens intended for DNA analysis during the preanalyti...
Withdrawn: 2019 06 01
Publisher:
Austrian Standards International
Format:
Digital | 21 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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, changes in the methylation status or even structural changes which can lead to e.g., spurious copy number changes in array-CGH profiles. 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.
ÖNORM EN ISO 20166-3
2019 06 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formal...
Norm
ONR CEN/TS 16827-3
2015 11 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE t...
Technische Regel
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ONR CEN/TS 16827-3
2015 04 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE t...
Technische Regel Entwurf
Norm
Issue date :
2014 12 01
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
Norm
Issue date :
2019 06 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)