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ISO 20166-1:2018

Current Revision

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

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 20166
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 212
Publish Date Document Id Type View
Not Available ISO 20166-1:2018 Revision