Norm

ISO/DIS 20166-2:2016 en

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

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Over deze norm

Status Ontwerp
Aantal pagina's 18
Commissie In vitro diagnostica
Gepubliceerd op 01-07-2016
Taal Engels
This International Standard recommends 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 International Standard 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, as well as institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities.This document is not applicable for protein examination by immunohistochemistry.

Details

ICS-code 11.100.10
Nederlandse titel Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins
Engelse titel Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins

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