标准摘要
[中文适用范围]： 此文件规定了下腔静脉滤器系统（包括滤器和输送系统）评估的要求，以及名称、设计属性和制造商提供的信息方面的要求。附录D中包含了体外测试方法开发的指导。本文件旨在与ISO 14630配合使用，ISO 14630规定了非活性外科植入物性能的一般要求。注1：由于受本文档涵盖的植入物设计差异的影响，在某些情况下还因新型植入物类型的出现，可接受的标准体外测试和临床结果并非总是可用的。随着更多科学和临床数据的获取，本文件可能需要进行修订。此文件适用于旨在通过捕获下腔静脉（IVC）中的血栓以预防症状性肺栓塞的下腔静脉滤器。尽管此文件对于其他静脉位置植入的滤器（如上腔静脉、髂静脉）也有一定的参考价值，但它并未具体针对这些植入部位使用滤器的问题。此外，本文件还适用于永久滤器及其相关输送系统、可取出的滤器及其相关回收系统以及可转换滤器及其相关转换系统。尽管此文件可以用于评估慢性植入后重新定位的滤器，但它未具体涉及滤器重新定位问题。此文件不适用于——需要在一定时间后移除的临时性滤器（如系带型），与存活组织和非存活生物材料有关的问题，以及静脉穿刺针等在此下腔静脉滤器程序之前的程序和设备。尽管可吸收滤器及带有可吸收涂层的滤器属于本文件范围，但本文件并未全面涵盖这些装置的可吸收特性。注2：可吸收植入物在ISO/TS 17137中有涉及。虽然带涂层的滤器及其系统也在本文件范围内，但它未全面涵盖涂层的相关内容。注3：血管装置-药物组合产品在ISO 12417-1中有规定，并且某些涂层特性在ISO 25539-4中有所涵盖。 [外文原描述]： This document specifies the requirements for the evaluation of vena cava filter systems (filters and delivery systems) and the requirements with respect to nomenclature, design attributes and information supplied by the manufacturer. Guidance for the development of in vitro test methods is included in Annex D. This document is intended to be used in conjunction with ISO 14630, which specifies general requirements for the performance of non-active surgical implants. NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, a revision of this document will be necessary. This document is applicable to vena cava filters intended to prevent symptomatic pulmonary embolism by capturing blood clots in the inferior vena cava (IVC). While this document can be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address the use of filters in other implantation sites. This document is also applicable to permanent filters together with their associated delivery systems, optional filters that can be retrieved and their associated retrieval systems, and convertible filters and their associated conversion systems. While this document can be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning. This document is not applicable to — temporary filters (e.g. tethered) that need to be removed after a defined period of time, — issues associated with viable tissues and non-viable biological materials, and — procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure. Although absorbable filters and filters with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these devices. NOTE 2 Absorbable implants are covered in ISO/TS 17137. Although coated filters and coated filter systems are within the scope of this document, this document is not comprehensive with respect to coatings. NOTE 3 Vascular device-drug combination products are covered in ISO 12417-1 and some coating properties are covered in ISO 25539-4.
英文名称Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters