ISO 25539-3:2011 心血管植入物 血管内器械 第3部分：腔静脉过滤器

标准编号：ISO 25539-3:2011

中文名称：心血管植入物 血管内器械 第3部分：腔静脉过滤器

英文名称：Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters

发布日期：2011-12

标准范围

基于当前医学知识，ISO 25539-3:20 11规定了腔静脉滤器的要求。关于安全性，它给出了预期性能、设计属性、材料、设计评价、制造、灭菌、包装和制造商提供的信息的要求。ISO 25539-3:20 11补充了ISO 14630，规定了非活性外科植入物性能的一般要求。以下内容属于ISO 25539-3:20 11的范围:用于通过下腔静脉中的机械过滤来预防肺栓塞的腔静脉过滤器:虽然ISO 25539-3:20 11对于植入在其他静脉位置（例如上腔静脉、髂静脉）的过滤器可能是有用的，但它没有具体解决过滤器在其他植入部位的使用；鞘/扩张器套件，条件是它们包括腔静脉过滤器的进入、递送或取回/转换的整体部件。递送系统，条件是它们包括腔静脉过滤器的部署的整体部件。可取回或转换的可选滤器，以及永久性滤器及其相关血管内系统:虽然ISO 25539-3:20 11可能有助于评价慢性植入后滤器的重新定位，但其并未具体说明滤器的重新定位。以下内容超出了ISO 25539-3:20 11的范围:需要在规定的时间段后移除的临时过滤器（例如系留的）；涂层、表面改性和/或药物；与活组织和非活组织相关的问题有活力的生物材料；可吸收材料的降解和其他时间依赖性方面；腔静脉滤器手术前使用的手术和器械（如静脉进入针）。

ISO 25539-3:2011 specifies requirements for vena cava filters, 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. ISO 25539-3:2011 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants.The following are within the scope of ISO 25539-3:2011:

• vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava: while ISO 25539-3:2011 might be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address use of filters in other implantation sites;
• sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrieval/conversion of the vena cava filter.
• delivery systems, providing that they comprise an integral component of the deployment of the vena cava filter.
• optional filters that can be retrieved or converted, and permanent filters together with their associated endovascular systems: while ISO 25539-3:2011 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning.

• temporary filters (e.g. tethered) that need to be removed after a defined period of time;
• coatings, surface modifications, and/or drugs;
• issues associated with viable tissues and non-viable biological materials;
• degradation and other time-dependent aspects of absorbable materials;
• procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.

标准预览图