ISO 5840:2005 心血管植入物. 心脏瓣膜修复术

标准编号：ISO 5840:2005

中文名称：心血管植入物. 心脏瓣膜修复术

英文名称：Cardiovascular implants — Cardiac valve prostheses

发布日期：2005-03

标准范围

ISO 5840:2005适用于作为心脏瓣膜替代物植入人体心脏的所有器械。它既适用于新开发和改良的心脏瓣膜替代物，也适用于其植入所需的附属器械、包装和标签，还适用于确定待植入的心脏瓣膜替代物的适当尺寸。ISO 5840:2005概述了通过风险管理对心脏瓣膜替代物的设计和制造进行鉴定的方法。适当确认试验和方法的选择源自风险评估。测试可以包括评估心脏瓣膜替代物及其材料和部件的物理、化学、生物和机械性能的那些。测试还可以包括用于成品心脏瓣膜替代物的临床前体内评估和临床评估的那些。如果有足够的科学和/或临床证据证明其合理性，ISO 5840:2005对心脏瓣膜替代物规定了设计规范和最低性能规范。它不包括设计用于植入人工心脏或心脏辅助设备的心脏瓣膜替代品。

ISO 5840:2005 is applicable to all devices intended for implantation in human hearts, as a heart valve substitute.It is applicable to both 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 heart valve substitute to be implanted.ISO 5840:2005 outlines an approach for qualifying 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 may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.ISO 5840:2005 imposes design specifications and minimum performance specifications for heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.It excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.

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