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| YY/T 1997-2026 General requirements for clinical investigation of in vitro diagnostic reagents (English Version) |
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Introduction of YY/T 1997-2026
本文件规定了体外诊断（IVD）试剂临床试验过程中人体生物样本管理的总体要求、保密性、伦理要求和样本采集、收集、运送及接收、保存、前处理、检测、处置、生物安全文件和记录的要求。
本文件适用于以注册为目的的体外诊断试剂临床试验。
Contents of YY/T 1997-2026