ISO 20166-2:2018

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

Published By	Publication Date	Number of Pages
ISO	2018-12	26

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Categories: 11.100.10 - In vitro diagnostic test systems, ISO

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Description

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.

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2018-12
Pages Count	26
Language	France
Edition	1
File Size	1.5 MB
ICS Codes	11.100.10 - In vitro diagnostic test systems

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ISO 20166-2:2018

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