心血管植入物.经导管心脏封堵器

[中文适用范围]： 本文件规定了重要的体外测试，包括经导管心脏封堵器及其输送系统和配件的功能和耐用特性。 本文件没有指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。 鉴于与经导管心脏封堵器相比，手术封堵器在装置几何形状、材料、植入方法和测试方法方面存在显着差异，因此已从本文件的范围中省略。 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、左心耳封堵器和瓣周漏封堵器）。 本文件不涵盖非心脏封堵器，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的范围内：手术设备、心脏分流设备、心房流量调节器、有源组件（例如传感器）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、其附属装置、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，其中有足够的科学或临床证据，或两者都有其合理性。 注：在撰写本文件时，不可能考虑到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，还可能需要进行超出本文件范围的测试。 [外文原描述]： 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.