标准摘要
[中文适用范围]： 本文件规定了适用于那些旨在通过听觉通路的电刺激来治疗听力障碍的有源植入式医疗设备的要求。 本文件不涵盖通过电刺激以外的方式治疗听力障碍的设备。 本文件中指定的测试是型式测试，应在设备样品上进行以显示合规性。 本文件也适用于设备的非植入部件和附件（见注）。 可植入部件的电气特性通过本文件中详述的适当方法或通过证明具有等于或优于指定方法的精度的任何其他方法来确定。 如有争议，适用本文件中详述的方法。 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，本文件规定了可能影响可植入部件的安全或性能的非植入部件和配件的要求。 [外文原描述]： This document specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this document. The tests that are specified in this document are type tests and are to be carried out on samples of a device to show compliance. This document is also applicable to non-implantable parts and accessories of the devices (see NOTE). The electrical characteristics of the implantable part are determined by either the appropriate method detailed in this document or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document applies. NOTE A 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, this document specifies those requirements of non-implantable parts and accessories which could affect the safety or performance of the implantable part.
英文名称Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems