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现行 ISO 23118:2021
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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma 分子体外诊断检验.尿 静脉血清和血浆中代谢组学的检验前过程规范
发布日期: 2021-05-18
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.
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发布单位或类别: 国际组织-国际标准化组织
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研制信息
归口单位: ISO/TC 212
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