ISO 5840-3:2021 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 5840-3:2021

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：2021-01

标准范围

本文件适用于所有拟作为经导管心脏瓣膜替代物植入的器械。本文件适用于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。本文件建立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。本文件定义了经导管心脏瓣膜替代物的操作条件和性能要求，如果有足够的科学和/或临床证据证明其合理性。本文件包括在预先存在的假体装置内植入经导管心脏瓣膜替代物的注意事项（例如，瓣膜中瓣膜和环中瓣膜配置）。

This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute.This document is applicable to 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.This document establishes 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 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.This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).

标准预览图