ISO 23118:2021 分子体外诊断 检查尿液、静脉血清和血浆代谢组学检查前程序规范

标准编号：ISO 23118:2021

中文名称：分子体外诊断 检查尿液、静脉血清和血浆代谢组学检查前程序规范

英文名称：Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma

发布日期：2021-05

标准范围

本文件规定了预检查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、从事生物医学研究的机构和公司、生物银行和监管机构使用。

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.

标准预览图