What is this standard about?
This document gives guidelines on the handling, documentation, storage and processing of formalinfixed and paraffin-embedded (FFPE) tissue specimens intended for RNA examination during the preexamination 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.