Name: CEN/TS 16827-1:2015
Brand: CEN

CEN/TS 16827-1:2015

Withdrawn

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA

Withdrawn date

03-09-2023

Published date

08-12-2015

Publisher

Comite Europeen de Normalisation

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Outside the laboratory
6 Inside the laboratory
Annex A (informative) - Quality control of RNA
        extracted from formalin fixed and paraffin
        embedded tissue samples: implications for
        RT-qPCR based analyses
Bibliography

This Technical Specification gives recommendations for 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, developers and manufacturers of in vitro diagnostics, 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.

Committee	CEN/TC 140
DocumentType	Technical Specification
PublisherName	Comite Europeen de Normalisation
Status	Withdrawn
SupersededBy	NEN-EN-ISO 20166-1 : 2019 NS-EN ISO 20166-1:2018 EN ISO 20166-1:2018

Standards	Relationship
S.R. CEN/TS 16827-1:2015	Identical
DIN CEN/TS 16827-1;DIN SPEC 13227-1:2015-11	Identical
UNI CEN/TS 16827-1 : 2015	Identical
PD CEN/TS 16827-1:2015	Identical
DIN SPEC 13227-1 : 2015	Identical
SIS-CEN/TS 16827-1: 2015	Identical
XP CEN/TS 16827-1 : 2015 XP	Identical

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