本文件适用于用于植入的心脏瓣膜替代物，并提供了一般说明 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 植入所需的辅助装置、包装和标签，以及确定 要植入的心脏瓣膜替代物的合适尺寸。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 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.All current amendments available at time of purchase are included with the purchase of this document.