心血管植入物. 心脏瓣膜假体. 第1部分: 通用要求

[中文适用范围]： 本文件适用于用于植入的心脏瓣膜替代品，并提供了一般要求。 ISO 5840 系列的后续部分提供了具体要求。 本文件适用于新开发和改进的心脏瓣膜替代品以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。 通过风险管理来替代。 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心脏瓣膜替代品及其材料和组件的物理、化学、生物和机械性能的测试。 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。 （例如用于体内再生的瓣膜），以及设计用于植入循环支持装置的心脏瓣膜替代品。 ISO 5840-1 的一些规定可适用于由无法存活的人体组织制成的瓣膜。 注：附录 A 给出了 ISO 5840-1 规定的基本原理。 [外文原描述]： This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. ISO 5840-1 outlines an approach for verifying/validating the design and manufacture of a 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 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. ISO 5840-1 defines operational conditions for heart valve substitutes. ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3. ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo ), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable. NOTE A rationale for the provisions of ISO 5840-1 is given in Annex A.