ISO 25539-1:2003 心脏血管移植-内血管设备-第1部分：内血管假体

标准编号：ISO 25539-1:2003

中文名称：心脏血管移植-内血管设备-第1部分：内血管假体

英文名称：Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses

发布日期：2003-03

标准范围

ISO 25539-1:2003根据当前医学知识规定了血管内假体的要求。在安全方面，它对预期性能、设计属性、材料、设计评估、制造、灭菌包装和制造商提供的信息提出了要求。应将其视为ISO 14630的补充，ISO 14630规定了非活性外科植入物性能的一般要求。ISO 25539-1:2003适用于用于治疗动脉瘤、动脉狭窄或其他适当血管异常的血管内假体。ISO 25539-1:2003适用于交付系统，前提是它们是血管内假体部署的一个组成部分。ISO 25539-1:2003不适用于血管封堵器，但对侧髂骨封堵器作为主动脉-单髂骨装置的组成部分使用时除外。有关排除的产品，请参见ISO 14630。ISO 25539-1:2003不适用于引入血管内系统之前使用的程序和设备，如球囊血管成形术设备。

ISO 25539-1:2003 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, which specifies general requirements for the performance of non-active surgical implants.ISO 25539-1:2003 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.ISO 25539-1:2003 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.ISO 25539-1:2003 is not applicable to vascular occluders, with the exception of contra-lateral iliac occluders when used as an integral part of an aorto-uni-iliac device. See ISO 14630 for excluded products.ISO 25539-1:2003 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.

标准预览图