GB 16174.2-2024
UpcomingImplants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers
手术植入物 有源植入式医疗器械 第2部分：心脏起搏器
Application Summary AI generated
This standard specifies the essential safety and performance requirements for cardiac pacemakers, including their leads and electrode systems. It is applied in the design, manufacturing, and testing of active implantable medical devices used to treat bradyarrhythmias and other cardiac rhythm disorders. The standard ensures clinical reliability and patient safety for pacemakers implanted in humans during surgical procedures.
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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.