GSO ISO 20166-1:2023
分子体外诊断检查 福尔马林固定石蜡包埋（FFPE）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 formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA

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标准号

GSO ISO 20166-1:2023

发布

2023年

发布单位

GSO

当前最新

GSO ISO 20166-1:2023

 

 

适用范围

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.

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