ISO 20166-1:2018

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

Standard Details

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.

General Information

Status : Published

Standard Type: Main

Document No: ISO 20166-1:2018

Document Year: 2018

Pages: 22

Edition: 1

Section Volume:
ISO/TC 212. Clinical laboratory testing and in vitro diagnostic test systems

ICS:
11.100.10 In vitro diagnostic test systems

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ISO 20166-1:2018

ISO 20166-1:2018

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