ISO 5840-2:2015 心血管植入物 心脏瓣膜假体 第2部分：外科手术植入心脏瓣膜替代品

标准编号：ISO 5840-2:2015

中文名称：心血管植入物 心脏瓣膜假体 第2部分：外科手术植入心脏瓣膜替代品

英文名称：Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

发布日期：2015-09

标准范围

ISO 5840-2:2015适用于植入人体心脏的心脏瓣膜替代物，通常需要体外循环，通常需要直接可视化。ISO 5840-2:2015适用于新开发和改进的外科心脏瓣膜替代物，以及植入所需的附件、包装和标签，并用于确定要植入的外科心脏瓣膜替代物的适当尺寸。ISO 5840-2:2015概述了通过风险管理对外科心脏瓣膜替代物的设计和制造进行鉴定的方法。从风险评估中选择适当的鉴定试验和方法。这些测试可能包括评估外科心脏瓣膜替代物及其材料和组件的物理、化学、生物和机械性能的测试。试验还可能包括临床前体内评价和成品外科心脏瓣膜替代物的临床评价。ISO 5840-2:2015定义了外科心脏瓣膜替代物的性能要求，其中有足够的科学和/或临床证据证明其合理性。对于新型外科心脏瓣膜替代品，如无缝合，本国际标准和ISO 5840？3的要求可能相关，并应视为适用于特定设备设计，并应基于风险分析的结果。ISO 5840-2:2015不包括用于植入人工心脏或心脏辅助装置的心脏瓣膜替代物。ISO 5840-2:2015不包括同种移植物。

ISO 5840-2:2015 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.ISO 5840-2:2015 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.ISO 5840-2:2015 outlines an approach for qualifying 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 may include those to assess the physical, chemical, biological, and mechanical properties of surgical 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 surgical heart valve substitute.ISO 5840-2:2015 defines performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and ISO 5840？3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis.ISO 5840-2:2015 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.ISO 5840-2:2015 excludes homografts.

标准预览图