标准摘要
[中文适用范围]： 本文件规定了有源植入式循环支持装置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：通常称为有源植入式医疗器械的器械实际上可以是单个器械、多个器械的组合、或者一个或多个器械与一个或多个附件的组合。 并非所有这些部件都需要部分或完全植入，但如果非植入部件和附件可能影响植入式设备的安全或性能，则需要指定主要要求。 本文件中指定的测试是型式测试，将在设备样本上进行，以评估设备行为响应，并不打算用于制造产品的常规测试。 本文件的范围包括： ——心室辅助装置 (VAD)、左心或右心支持； ——全人工心脏（TAH）； ——双心室辅助装置（biVAD）； ——经皮辅助装置； ——儿科辅助装置。 [外文原描述]： 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.
英文名称Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices