標準號：DIN EN ISO 25539-1-2018
中文標準名稱：心血管植入物.心血管裝置.第1部分:心血管假體(ISO 25539-1-2017);德文版本EN ISO 25539-1-2017
英文標準名稱：Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017); German version EN ISO 25539-1:2017
標準類型：C45
發(fā)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：C45
國際標準分類號：11.040.40
引用標準：DIN EN ISO 5840-1-2015;DIN EN ISO 7198-2017;DIN EN ISO 10555-1-2018;DIN EN ISO 10555-4-2013;DIN EN ISO 10993-1-2010;DIN EN ISO 11070-2015;DIN EN ISO 11135-2014;DIN EN ISO 11607-1-2017;DIN EN ISO 13485-2016;DIN EN ISO 14155-2012;DIN EN ISO 14160-2011;DIN E
適用范圍：Part 1 of ISO 25539 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 supplied by the manufacturer. It should be considered as a supplement to ISO 14630. This International Standard is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities. This International Standard is in addition applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.