標準號：BS EN ISO 25539-1-2009
中文標準名稱：心血管植入物.血管內設備.血管內假體
英文標準名稱：Cardiovascular implants - Endovascular devices - Endovascular prostheses
標準類型：C45
發布日期：2003/3/27 12:00:00
實施日期：2003/3/27 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：ISO 7198-1998;ISO 11134-1994;ISO 11135-1994;ISO 11137-1995;ISO 10993;ISO 11607-1997;ISO 13485;ISO 13488-1996;ISO 14155;ISO 14160;ISO 14630-1997;ISO 14937;ISO 14971-2000
適用范圍：1.1 This part of ISO 25539 specifies requirements for endovascular prostheses, based upon currentmedical knowledge. With regard to safety, it gives requirements for intended performance, design attributes,materials, design evaluation, manufacturing, sterilization packaging and information supplied by themanufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirementsfor the performance of non-active surgical implants.1.2 This part of ISO 25539 is applicable to endovascular prostheses used to treat arterial aneurysms,arterial stenoses, or other appropriate vascular abnormalities.1.3 This part of ISO 25539 is applicable to delivery systems if they comprise an integral component of thedeployment of the endovascular prostheses.1.4 This part of ISO 25539 is not applicable to vascular occluders, with the exception of contra-lateral iliacoccluders when used as an integral part of an aorto-uni-iliac device. See ISO 14630 for excluded products.1.5 This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of theendovascular system (defined in 3.6), such as balloon angioplasty devices.