ISO 5840-1:2021 心血管植入物 心脏瓣膜假体 第1部分：一般要求
标准编号：ISO 5840-1:2021
中文名称：心血管植入物 心脏瓣膜假体 第1部分：一般要求
英文名称：Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
发布日期：2021-01
标准范围
本文件适用于拟用于植入的心脏瓣膜替代物，并提供了一般要求。ISO 5840系列的后续部分提供了具体要求。本文件适用于新开发和改良的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 5840-1概述了通过风险管理验证/确认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 5840-1定义了心脏瓣膜替代物的操作条件。此外，ISO 5840-1定义了也适用于ISO 5840-2和ISO 5840-3的术语。ISO 5840-1没有提供针对同种移植物、组织工程化心脏瓣膜（例如旨在体内再生的瓣膜）和设计用于植入循环支持装置的心脏瓣膜替代物的特定要求。ISO 5840-1的一些规定可以应用于由变得无活力的人体组织制成的瓣膜。注:ISO 5840-1规定的依据见附录A。
This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.This document is applicable to 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 the heart valve substitute to be implanted.ISO 5840-1 outlines an approach for verifying/validating 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 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.ISO 5840-1 defines operational conditions for heart valve substitutes.ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3.ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable.NOTE A rationale for the provisions of ISO 5840-1 is given in Annex A.
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