ISO 20166-1:2018

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA

This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for RNA 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.

Edition	2018
Standard Part No	1
Published Date	2018
Published By	International Standardization Organisation
Page Count	22