ISO 20166-3E Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed.
This document is available in electronic format only.
Date of Publication: December 14, 2018
Order Code PDF: ISO201663E
Order Code Print: print not available
ISO 20166-3:2018 Additional Details
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.
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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.