BS EN 45502-2-3-2010 有源可植入医疗器械.耳蜗和听觉脑干植入系统的详细要求

标准号：BS EN 45502-2-3-2010
中文标准名称：有源可植入医疗器械.耳蜗和听觉脑干植入系统的详细要求
英文标准名称：Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
标准类型：C45
发布日期：2010/3/31 12:00:00
实施日期：2010/3/31 12:00:00
中国标准分类号：C45
国际标准分类号：11.040.40
适用范围：This Part 2-3 of EN 45502 specifies requirements that are applicable to those ACTIVE IMPLANTABLEMEDICAL DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditorypathways. Devices which treat hearing impairment via means other than electrical stimulation are notcovered by this European Standard.The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a deviceto show compliance.The electrical characteristics of the IMPLANTABLE PART shall be determined by either the appropriatemethod detailed in this particular standard or by any other method demonstrated to have an accuracyequal to, or better than, the method specified. In the case of dispute, the method detailed in this particularstandard shall apply.