GB 16174.1-2024
UpcomingImplants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
手术植入物 有源植入式医疗器械 第1部分：安全、标记和制造商所提供信息的通用要求
Application Summary AI generated
This standard specifies general safety requirements, marking, and manufacturer information for active implantable medical devices used in surgery, such as pacemakers, neurostimulators, and implantable drug pumps. It applies to the design, testing, and regulatory compliance of these devices within China, ensuring they meet essential safety and performance criteria for clinical use. The standard is primarily used by medical device manufacturers, testing laboratories, and regulatory bodies to evaluate and certify active implants before market approval.
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