GB 16174.1-2015
ActiveImplants 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 such as pacemakers, neurostimulators, and implantable defibrillators. It is applied in the design, testing, and regulatory approval of these devices within China’s healthcare industry to ensure patient safety and proper device functionality. The standard also governs labeling and instructions for use provided to clinicians and patients.
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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.