有源植入式医疗器械国际标准ISO 14708-1新旧版本对比分析

Comparative analysis of the Latest and Old Versions of the International Standard of Active Implantable Medical Devices Named ISO14708-1

目的:探讨有源植入式医疗器械新版ISO14708-1∶2014标准,为研发人员及监管人员提供参考。方法:结合实际工作,对ISO14708-1∶2014与旧版标准ISO14708-1∶2000的差异进行对比和分析。结果:ISO14708-1∶2014标准对大量条款进行技术上的修订,对有源植入式医疗器械提出了新的要求。结论:新版标准为有源植入式医疗器械的检测提供了更严谨、详细的要求及检测方法,对适应新形势下有源植入式医疗器械的发展需要具有重要意义。

Objective: The latest version standard of active implantable medical devices(AIMDs) named ISO 14708-1:2014 were explored to provide references for developers and supervisors. Methods: The differences between ISO 14708-1:2014 and the old version of ISO 14708-1:2000 were compared and analyzed combining daily work. Results: ISO 14708-1:2014 made technical revisions on a large number of clauses, which proposed new requirements for AIMDs. Conclusion: The latest edition of the standard provides more rigorous and detailed requirements and testing methods for the detection of active implantable medical devices, which are of great significance to adapt to the rapid development of active implantable medical device industry under the new situation.