ISO 20184-2:2018 分子体外诊断检验 冷冻组织预检验过程规范 第2部分：分离蛋白

标准编号：ISO 20184-2:2018

中文名称：分子体外诊断检验 冷冻组织预检验过程规范 第2部分：分离蛋白

英文名称：Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins

发布日期：2018-11

标准范围

本文件给出了在进行分子测定之前的预检查阶段用于分离蛋白检查的冷冻组织样本的处理、记录、储存和处理指南。本文件适用于医学实验室和分子病理学实验室进行的评估从冷冻组织中分离的蛋白质的任何分子体外诊断检查。它还旨在供实验室客户、体外诊断开发商和制造商、生物库、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档中涵盖的特定主题。

This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated proteins 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 proteins isolated 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.NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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