Norm

NVN-CEN/TS 16826-1:2015 en

Moleculair in vitro diagnostisch onderzoek - Specificatie voor de pre-onderzoeksprocessen voor snel ingevroren weefsel - Deel 1: Geïsoleerd RNA

49,30

Over deze norm

Status Definitief
Aantal pagina's 16
Commissie In vitro diagnostica
Gepubliceerd op 01-09-2015
Taal Engels
NVN-CEN/TS 16826-1 gives recommendations for 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, developers and manufacturers of in vitro diagnostics, 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 tissues from different donors / patients. 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.

Details

ICS-code 11.100.10
Nederlandse titel Moleculair in vitro diagnostisch onderzoek - Specificatie voor de pre-onderzoeksprocessen voor snel ingevroren weefsel - Deel 1: Geïsoleerd RNA
Engelse titel Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA

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