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

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.

标准预览图