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DIN CEN/TS 16826-1 DIN SPEC 13226-1:2015-12

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DIN CEN/TS 16826-1 DIN SPEC 13226-1:2015-12

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA; German version CEN/TS 16826-1:2015

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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, it is essential to take special measures 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.

Author DIN
Editor DIN
Document type Standard
Format File
ICS 11.100.10 : In vitro diagnostic test systems
Number of pages 20
Replaced by DIN EN ISO 20184-1 (in Vorbereitung/in preparation/en préparation)
Cross references CEN/TS 16826-1 (2015-08), IDT
Set MYSTD-20STD
Year 2015
Document history
Country Germany
Keyword DIN CEN/TS 16826;16826