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EVS-EN ISO 20166-2:2018

Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018)

General information

Valid from 03.01.2019
Base Documents
ISO 20166-2:2018; EN ISO 20166-2:2018
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.01.2019
Main
02.09.2015
Main
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for the examination of isolated proteins 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.
This document is not applicable for protein examination by immunohistochemistry.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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