SS-EN-ISO-20166-1 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018)

SS-EN-ISO-20166-1 - 2019 EDITION - CURRENT

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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.

To find similar documents by classification:

11.100.10 (In vitro diagnostic test systems)

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Designation Name

SS-EN ISO 20166-1:2019

Revision Level




Publication Date

Jan. 8, 2019



Page Count


International Equivalent

EN ISO 20166-1:2018(IDT); ISO 20166-1:2018(IDT)