Standard Number: YY 0989.7-2017(YY0989.7-2017)
Chinese:手术植入物 有源植入式医疗器械 第7部分:人工耳蜗植入系统的专用要求
English:Implants for surgery-Active implantable medical devices-Part7:Particular requirements for cochlear implant systems
Effective Date:2018-01-01
ICS:11.040.40
Standard Applicability:This standard specifies requirements specific to active implantable medical devices that are intended to treat hearing impairment through electrical stimulation of the auditory pathway, and this standard applies equally to certain non-implantable parts and accessories of the device. This standard does not apply to devices intended to treat hearing impairment by means of non-electrical stimulation. The electrical characteristics of the implanted part shall be verified by appropriate methods listed in this part or by other methods whose accuracy can be demonstrated to be equal to or better than those specified. In case of dispute, the methods specified in this part shall be used.
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