SS-EN-ISO-20166-4 Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques (ISO 20166-4:2021)

SS-EN-ISO-20166-4 - 2021 EDITION - CURRENT

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This document gives requirements for the collection, handling, documentation, transport, storage and processing during the pre-examination phase of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for examinations of morphology and biomolecules, such as metabolites, proteins, DNA and/or RNA in situ on FFPE tissue sections by using different in situ detection techniques. This document is applicable to routine and molecular diagnostic examinations using in situ detection techniques including laboratory developed tests performed by routine pathology laboratories (histology laboratories) as well as molecular pathology laboratories and other medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, as well as institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities. This document is not applicable for the examination of isolated biomolecules such as proteins, DNA and RNA that cannot be mapped with a defined region of a FFPE section. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

To find similar documents by classification:

11.100 (Laboratory medicine)

11.100.10 (In vitro diagnostic test systems)

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Designation Name

SS-EN ISO 20166-4:2021

Revision Level




Publication Date

Aug. 5, 2021



Page Count


International Equivalent

EN ISO 20166-4:2021(IDT); ISO 20166-4:2021(IDT)