心血管植入物. 心脏瓣膜假体. 第2部分: 外科植入心脏瓣膜替代物

[中文适用范围]： 本文件适用于用于植入人类心脏的心脏瓣膜替代物，通常需要体外循环并且通常需要直接可视化。 有关外科心脏瓣膜替代物及其组件的示例，请参阅附录 E。 本文件适用于新开发和改进的外科心脏瓣膜替代物以及植入所需的附件装置、包装和标签，以及确定要植入的外科心脏瓣膜替代物的适当尺寸。 本文件建立了一种通过风险管理来验证/验证外科心脏瓣膜替代品的设计和制造的方法。 适当的资格测试和方法的选择源自风险评估。 这些测试可包括评估外科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手术心脏瓣膜替代品进行临床前体内评估和临床评估的测试。 本文件定义了外科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。 对于某些心脏瓣膜替代品（例如无缝线），本文件的要求并基于风险分析的结果。 [外文原描述]： This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components. This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.