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Normas DIN – AENOR
DIN CEN/TS 16827-1:2015-11;DIN SPEC 13227-1:2015-11

DIN CEN/TS 16827-1:2015-11;DIN SPEC 13227-1:2015-11

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA; German version CEN/TS 16827-1:2015

Tests de diagnostic moléculaire in vitro - Spécifications rélatives aux processus préanalytiques pour les tissus FFPE - Partie 1: ARN extrait; Version allemande CEN/TS 16827-1:2015

Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für FFPE-Gewebeproben - Teil 1: Isolierte RNS; Deutsche Fassung CEN/TS 16827-1:2015

Fecha Anulación:
2019-04 /Withdrawn
Equivalencias internacionales:

CEN/TS 16827-1 (2015-08)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 20166-1:2019-04

Resumen:
This Technical Specification recommends the handling, documentation and processing of FFPE 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 organizations performing biomedical research, biobanks, and regulatory authorities). The formalin-fixation and the paraffin embedding process lead to modifications of the RNA molecules, which can impact the validity and reliability of the analytical test results. Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis.
Keywords:
Biomedical, Definitions, Investigations, In-vitro diagnostic, Medical sciences, Medical technology, Methods of analysis, Molecular structure, Ribonucleic acid, Samples, Specification (approval), Specimens, Storage, Tissue
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