ANSI/AAMI/ISO 25539-1-2003 心血管植入物.血管内装置.第1部分:血管内修复体

标准号：ANSI/AAMI/ISO 25539-1-2003
中文标准名称：心血管植入物.血管内装置.第1部分:血管内修复体
英文标准名称：Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
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
适用范围：Specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information to be supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. NOTE- The document was formerly designated 15539-1 but was changed to 25539-1 at the DIS stage by ISO to distinguish it from ISO/TS 15539.