标准摘要
[中文适用范围]： 本文件规定了预检过程中用于代谢组学分析的尿液、静脉血浆和血清的处理、记录和处理的要求并给出了建议。 本文件适用于代谢组学检查，可供生物医学实验室、实验室客户、体外诊断开发商和制造商、进行生物医学研究的机构和公司、生物样本库和监管机构使用。 [外文原描述]： This document specifies requirements and gives recommendations for the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis in the pre-examination processes. This document is applicable to metabolomics examinations and can be used by biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities.
英文名称Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma