本文件适用于作为经导管心脏瓣膜植入的所有设备 代替 本文件适用于经导管心脏瓣膜替代物和附属设备， 植入和确定适当尺寸所需的包装和标签 植入心脏瓣膜替代物。 本文件确立了一种验证/确认产品设计和制造的方法 通过风险管理的经导管心脏瓣膜替代物。选择合适的 验证/确认试验和方法将从风险评估中得出。测试可以 包括评估心脏瓣膜的物理、化学、生物和机械性能 替代品及其材料和组件的使用。这些测试还可以包括临床前临床试验 成品心脏瓣膜替代物的体内评价和临床评价。购买本文件时可获得的所有当前修订均包含在购买本文件中。

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.All current amendments available at time of purchase are included with the purchase of this document.