GSO ISO 20184-1:2023
分子体外诊断检查 冷冻组织预检查过程规范 第1部分：分离RNA

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

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标准号

GSO ISO 20184-1:2023

发布

2023年

发布单位

GSO

当前最新

GSO ISO 20184-1:2023

 

 

适用范围

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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