ISO 5840-3:2013 心血管植入物 心脏瓣膜假体 第3部分：通过导管技术植入心脏瓣膜替代品

标准编号：ISO 5840-3:2013

中文名称：心血管植入物 心脏瓣膜假体 第3部分：通过导管技术植入心脏瓣膜替代品

英文名称：Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques

发布日期：2013-03

标准范围

ISO 5840-3:20 13概述了通过风险管理验证/确认经导管心脏瓣膜替代物的设计和制造的方法。根据风险评估选择适当的验证/确认试验和方法。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。ISO 5840-3:20 13定义了经导管心脏瓣膜替代物的操作条件和性能要求，如果存在足够的科学和/或临床证据证明其合理性。ISO 5840-3:20 13适用于预期作为经导管心脏瓣膜替代物植入人体心脏的所有器械。ISO 5840-3:20 13适用于新开发和改良的经导管心脏瓣膜替代物及其植入所需的附件器械、包装和标签以及确定待植入心脏瓣膜替代物的适当尺寸。

ISO 5840-3:2013 outlines 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 may 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 5840-3:2013 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.ISO 5840-3:2013 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute.ISO 5840-3:2013 is applicable to both newly developed and modified 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.

标准预览图