ISO 20166-2:2018 Preview

Molecular in vitro diagnostic examinations -- Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 2: Isolated proteins

This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for the examination of isolated proteins 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.

This document is not applicable for protein examination by immunohistochemistry.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.


General information

  • Status :  Published
    Publication date : 2018-12
  • Edition : 1
    Number of pages : 19
  • :
    ISO/TC 212
    Clinical laboratory testing and in vitro diagnostic test systems
  • 11.100.10
    In vitro diagnostic test systems

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