ISO 14708-5-2010 外科植入物.有源可植入医疗装置.第5部分:循环支撑装置

标准号：ISO 14708-5-2010
中文标准名称：外科植入物.有源可植入医疗装置.第5部分:循环支撑装置
英文标准名称：Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
标准类型：C35
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C35
国际标准分类号：11.040.40
引用标准：ISO 5198;ISO 5840;ISO 7198;ISO 10993-1;ISO 14155;ISO 14708-1;ISO 14971;IEC 60601-1;IEC 60601-1-1;IEC 60601-1-2;IEC 60601-1-8;IEC 62304
适用范围：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.