标准编号：ISO 14708-5:2010
中文名称：外科植入物 有源植入性医疗器械 第5部分：循环支持装置
英文名称：Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
发布日期：2010-02
标准范围
This part of ISO 14708 specifies requirements for safety and performance of active implantable circulatorysupport devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraintdevices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps.This part of ISO 14708 specifies type tests, animal studies and clinical evaluation requirements.
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