ISO 20166-3:2018

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ISO 20166-3:2018 is an international standard that provides guidelines for the pre-examination processes of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination in molecular in vitro diagnostic examinations. It specifically focuses on the handling, documentation, storage, and processing of FFPE tissue before a molecular assay is performed. This standard is relevant for various stakeholders, including medical laboratories, pathology laboratories, in vitro diagnostics developers and manufacturers, and biobanks.