ISO 20166-2:2018
p
ISO 20166-2:2018
69802

Status : Published (Under review)

en
Format Language
std 1 129 PDF + ePub
std 2 129 Paper
  • CHF129
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Abstract

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.

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General information

  •  : Published
     : 2018-12
    : International Standard under systematic review [90.20]
  •  : 1
     : 19
  • ISO/TC 212
    11.100.10 
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