心血管植入物. 心脏瓣膜假体. 第3部分: 由经导管技术植入的心脏瓣膜假体

[中文适用范围]： 本文件适用于作为经导管心脏瓣膜替代品植入的所有装置。 本文件适用于经导管心脏瓣膜替代品及其植入所需的附件装置、包装和标签，以及确定要植入的心脏瓣膜替代品的适当尺寸。 本文件建立了一种通过风险管理来验证/确认经导管心脏瓣膜替代品的设计和制造的方法。 适当的验证/确认测试和方法的选择应根据风险评估得出。 这些测试可包括评估心脏瓣膜替代物及其材料和组件的物理、化学、生物和机械特性的测试。 这些测试还可以包括对成品心脏瓣膜替代品进行临床前体内评估和临床评估的测试。 本文件定义了经导管心脏瓣膜替代物的操作条件和性能要求，其中有足够的科学和/或临床证据证明其合理性。 本文件包括在现有假体装置（例如瓣中瓣和瓣环配置）内植入经导管心脏瓣膜替代物的注意事项。 [外文原描述]： This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute. This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).