標(biāo)準(zhǔn)號(hào)：ANSI/AAMI/ISO 25539-1-2003
中文標(biāo)準(zhǔn)名稱：心血管植入物.血管內(nèi)裝置.第1部分:血管內(nèi)修復(fù)體
英文標(biāo)準(zhǔn)名稱：Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
標(biāo)準(zhǔn)類型：C35
發(fā)布日期：1999/12/31 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國標(biāo)準(zhǔn)分類號(hào)：C35
國際標(biāo)準(zhǔn)分類號(hào)：11.040.40
適用范圍：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.