UNE-EN ISO 20166-2:2019

This International Standard recommends the handling, documentation, storage and processing offormalin- fixed and paraffin-embedded (FFPE) tissue specimens intended for the examination ofisolated proteins during the pre-examination phase before a molecular assay is performed. ThisInternational Standard is applicable to molecular in vitro diagnostic examinations including laboratorydeveloped tests performed by medical laboratories and molecular pathology laboratories. It is alsointended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, aswell as institutions and commercial organizations performing biomedical research, biobanks, andregulatory authorities.This document is not applicable for protein examination by immunohistochemistry.NOTE International, national or regional regulations or requirements may also apply to specific topicscovered in this International Standard.