BS EN ISO 25539-1-2009 心血管植入物.血管内设备.血管内假体

标准号：BS EN ISO 25539-1-2009
中文标准名称：心血管植入物.血管内设备.血管内假体
英文标准名称：Cardiovascular implants - Endovascular devices - Endovascular prostheses
标准类型：C45
发布日期：2003/3/27 12:00:00
实施日期：2003/3/27 12:00:00
中国标准分类号：C45
国际标准分类号：11.040.40
引用标准：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
适用范围：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.