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。购买本文件时可获得的所有当前修订均包含在购买本文件中。

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.All current amendments available at time of purchase are included with the purchase of this document.