UNE-EN ISO 20166-3:2019

This International Standard recommends the handling, documentation, storage and processing offormalin fixed and paraffin embedded (FFPE) tissue specimens intended for DNA examination duringthe pre-examination phase before a molecular assay is performed. This International Standardis applicable to molecular in vitro diagnostic examinations including laboratory developed testsperformed by medical laboratories and molecular pathology laboratories. It is also intended to be usedby laboratory customers, in vitro diagnostics developers and manufacturers, as well as institutions andcommercial organizations performing biomedical research, biobanks, and regulatory authorities.NOTE International, national or regional regulations or requirements may also apply to specific topicscovered in this International Standard.