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Technische Regel Entwurf
ONR CEN/TS 16827-3
Issue date: 2015 04 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3: Isolated DNA (prCEN/TS 16827-3:2015)
This Technical Specification recommends the handling, documentation and processing of FFPE tissue specimens intended for DNA analysis during the preanalytical phase befor...
Withdrawn: 2015 11 01
Publisher:
Austrian Standards International
Format:
Digital | 18 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This Technical Specification recommends 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, in vitro diagnostics developers and manufacturers, 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.
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
ONR CEN/TS 16827-3
2015 04 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE t...
Technische Regel Entwurf
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Technische Regel
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)