GB/T 47200-2026
UpcomingCopper-bearing intrauterine contraceptive devices—Guidance on the design, execution, analysis and interpretation of clinical studies
含铜宫内节育器 临床研究的设计、执行、分析和解释指南
Application Summary AI generated
This standard provides specific guidance for conducting clinical studies on copper-bearing intrauterine contraceptive devices (IUDs) in China. It covers the design, execution, data analysis, and interpretation of trials to ensure safety and efficacy evaluations are consistent and scientifically valid. The standard is applied by medical device manufacturers, clinical research organizations, and regulatory bodies during the pre-market approval process for new or modified copper IUDs.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.