ISO 22679:2021 心血管植入物 经导管心脏封堵器

标准编号：ISO 22679:2021

中文名称：心血管植入物 经导管心脏封堵器

英文名称：Cardiovascular implants — Transcatheter cardiac occluders

发布日期：2021-11

标准范围

本文件规定了重要的体外试验，包括经导管心脏封堵器及其输送系统和附件的功能和耐久性特征。本文件未规定功能和耐久性测试的确切测试方法，但提供了心脏封堵器系统性能测试的要求和建议。鉴于外科封堵器在设备几何形状、材料、植入方法和测试方法方面与经导管心脏封堵器相比存在显著差异，因此本文件中省略了外科封堵器。本文件适用于所有用于经导管植入人体的心内封堵器（例如，房间隔封堵器、室间隔封堵器、卵圆孔未闭封堵器、左心耳封堵器和瓣旁漏封堵器）。本文件不包括非心脏封堵器，但本文件的内容可适用于动脉导管未闭封堵器。以下设备和组件不在本文件范围内:手术设备、心脏分流设备、心房流量调节器、活性组件（如传感器）或可降解或动物组织组件。本文件适用于新开发和改进的心脏封堵器及其附属设备、包装和标签。本文件定义了心脏封堵器的操作条件和性能要求，其中有充分的科学或临床证据，或两者都存在，以证明其合理性。注:在编写本文件时，不可能考虑所有未来和新兴技术。基于这些新技术的心脏封堵器系统可以受益于基于本文件基本要求的评估。为了验证和验证这些心脏封堵器系统，也可能需要进行超出本文件范围的测试。

This document specifies important in vitro tests including functional and durability characteristics of transcatheter cardiac occluders, and their delivery systems and accessories. This document does not specify exact test methods for functional and durability testing, but it offers requirements and recommendations for performance tests of the cardiac occluder system.Surgical occluders have been omitted from the scope of this document given their significant differences in device geometry, materials, implantation methods, and test methods as compared to transcatheter cardiac occluders.This document is applicable to all intracardiac occluders intended for transcatheter implantation in humans (e.g. atrial septal occluder, ventricular septal occluder, patent foramen ovale occluder, left atrial appendage occluder, and paravalvular leak occluders). This document does not cover non-cardiac occluders, but elements of this document can be applicable to patent ductus arteriosus occluders.The following devices and components are outside the scope of this document: surgical devices, cardiac shunt devices, atrial flow regulators, active components (such as sensors), or degradable or animal tissue components.This document is applicable to both newly developed and modified cardiac occluders, their accessory devices, packaging, and labelling.This document defines operational conditions and performance requirements for cardiac occluders where either adequate scientific or clinical evidence, or both, exists for their justification.NOTE      At the time of this document, it is impossible to take all future and emerging technologies into consideration. The cardiac occluder systems based on these new technologies can benefit from evaluation based on the basic requirements of this document. Testing beyond the scope of this document can also be necessary in order to verify and validate these cardiac occluder systems.

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