分子体外诊断检查 - 福尔马林固定和石蜡包埋（Ffpe）组织的预检过程规范 - 第1部分:孤立的Rna

[中文适用范围]： 本文件提供了有关在进行分子测定之前的预检查阶段用于 RNA 检查的福尔马林固定石蜡包埋 (FFPE) 组织标本的处理、记录、储存和处理的指南。 本文件适用于分子体外诊断检查，包括由医学实验室和分子病理学实验室进行的实验室开发的测试。 它还旨在供实验室客户、体外诊断开发商和制造商、生物银行、进行生物医学研究的机构和商业组织以及监管机构使用。 注：国际、国家或地区法规或要求也适用于本文件中涵盖的特定主题。 [外文原描述]： 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.