本文件规定了适用于那些旨在通过听觉通路的电刺激治疗听力损伤的有源植入式医疗器械的要求。通过电刺激以外的方式治疗听力损伤的设备不在本文件的范围内。 本文件中规定的试验为型式试验，将在器械样品上进行，以显示符合性。 本文件也适用于器械的非植入部件和附件（见注释）。 可植入部件的电特性通过本文档中详述的适当方法或通过被证明具有等于或优于指定方法的准确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。注意，通常被称为有源植入式医疗装置的装置实际上可以是单个装置、装置的组合、或一个或多个装置与一个或多个附件的组合。并非所有这些部件都要求部分或全部可植入，本文件规定了可能影响可植入部件安全性或性能的非可植入部件和附件的要求。

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.