ISO 5840-2:2021 心血管植入物 心脏瓣膜假体 第2部分：外科植入心脏瓣膜代用品
标准编号：ISO 5840-2:2021
中文名称：心血管植入物 心脏瓣膜假体 第2部分：外科植入心脏瓣膜代用品
英文名称：Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
发布日期：2021-01
标准范围
本文件适用于拟植入人体心脏的心脏瓣膜替代物，通常需要体外循环且通常具有直接可视化。外科心脏瓣膜替代物及其组件示例见附录E。本文件适用于新开发和改良的外科心脏瓣膜替代物及其植入所需的附件器械、包装和标签，以及确定待植入的外科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/确认外科心脏瓣膜替代物的设计和制造的方法。适当确认试验和方法的选择源自风险评估。测试可以包括评估外科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外科心脏瓣膜替代物的临床前体内评估和临床评估的那些。本文件定义了外科心脏瓣膜替代物的操作条件和性能要求，在有足够的科学和/或临床证据证明其合理性的情况下。对于某些心脏瓣膜替代物（例如无缝合线），本文件和ISO 5840-3:20 21的要求可能是相关的，并且被认为适用于特定的器械设计，并且基于风险分析的结果。
This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.This document establishes an approach for verifying/validating the design and manufacture of a surgical 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 surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.
标准预览图
