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| YY/T 1956-2025 Clinical investigation of in vitro diagnostic reagents—Terms and definitions (English Version) |
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Introduction of YY/T 1956-2025
本文件界定了体外诊断试剂临床试验涉及的术语和定义，包括体外诊断试剂临床试验设计、实施、记录和报告等过程中使用的术语和定义。
本文件所指体外诊断试剂是指按照医疗器械管理的体外诊断试剂。
本文件适用于体外诊断试剂临床试验。
Contents of YY/T 1956-2025