標準號：ISO 14708-5-2010
中文標準名稱：外科植入物.有源可植入醫療裝置.第5部分:循環支撐裝置
英文標準名稱：Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
標準類型：C35
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C35
國際標準分類號：11.040.40
引用標準：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
適用范圍：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.