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ISO 20184-1:2018

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
22 nën 2018

General information

90.93     12 dhj 2024

ISO

ISO/TC 212

International Standard

11.100.10  

anglisht   frëngjisht  

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Scope

This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate RNA extracted from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Life cycle

NOW

PUBLISHED
ISO 20184-1:2018
90.93 Standard confirmed
12 dhj 2024

REVISED BY

IN_DEVELOPMENT
ISO/PWI 20184-1