本文件规定了主动植入式循环支持设备的安全性和性能要求，包括型式试验、动物研究和临床评估要求。 注:通常被称为主动植入式医疗设备的设备实际上可以是单个设备、设备组合，或者一个或多个设备和一个或多个附件的组合。并非所有这些零件都要求部分或完全可植入，但需要明确非植入材料的主要要求- 可植入部件和附件，如果它们可能影响可植入设备的安全或性能。 本文件中规定的试验为型式试验，将在装置样品上进行，以评估装置的行为反应，不用于制造产品的常规试验。 本文件范围包括: -心室辅助装置（VAD），左或右心脏支持； -人工心脏总数（TAH）； -双心室辅助装置； -经皮辅助装置； -儿科辅助设备。

This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements. NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products. Included in the scope of this document are: — ventricular assist devices (VAD), left or right heart support; — total artificial hearts (TAH); — biventricular assist devices (biVAD); — percutaneous assist devices; — paediatric assist devices.