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MEST EN ISO 20166-3:2020

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)

Dec 1, 2020

Published

Standard

European Norm

1

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Related project

Adopted from EN ISO 20166-3:2019

Adopted from ISO 20166-3:2018

Replaces MEST CEN/TS 16827-3:2017

Scope

This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Project

MEST EN ISO 20166-3:2020

60.60 Standard published

ICS

11.100.10 11.100.10 11.100.10