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EVS-EN ISO 20184-1:2018

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018)

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Kehtiv alates 03.01.2019
Alusdokumendid
ISO 20184-1:2018; EN ISO 20184-1:2018
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Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
03.01.2019
Põhitekst
02.09.2015
Põhitekst
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.

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