人工耳蜗植入体刺激器外壳气密性检测方法  

On Detection Method of the Hermeticity of the Stimulator Case of the Cochlear Implant System

作　　者：付丽 陈甜甜 张克[1] 张在爱 蒋硕[1] Fu Li;Chen Tiantian;Zhang Ke;Zhang Zaiai;Jiang Shuo(Medical Equipment Department,Shandong Quality Inspection Center for Medical Devices,Jinan Shandong 250101,China)

机构地区：[1]山东省医疗器械产品质量检验中心医用电器室,山东济南250101

出　　处：《医疗装备》2020年第5期46-48,共3页Medical Equipment

摘　　要：在人工耳蜗植入系统中,刺激器是接收、处理电信号、保证刺激电极正确刺激人体耳蜗神经的核心部件。刺激器外壳的密封性保证了刺激器内部电路与人体之间的有效隔离,既可以防止内部电路所含的有害成分渗入到人体,又可以保证体液不会腐蚀内部电路,对患者的生命安全及患者感知声音的效果有着重要影响。YY0989.7-2017是针对人工耳蜗植入系统的专用要求,现分析影响该标准规定整体泄漏检测的准确性因素,阐述整体泄漏检测过程中所遇到的问题,并给予解决方法和注意事项。In the cochlear implant system, the stimulator is the core components to receive and deal with the electrical signal and ensure the stimulating electrode can stimulate the cochlear nerve of the body correctly. The hermeticity of the stimulator case ensure the effective isolation between the internal circuit of the stimulator and the human body, it’s not only can prevent the harmful components contained in the internal circuit from penetrating into the human body, but also can ensure the body fluid will not corrode the internal circuit, so it has an important impact on the life safety of patients and the effect of patient’s perception of voice. YY0989.7-2017 is the particular requirements for cochlear implant systems, the paper focuses on the analysis of the factors affecting the accuracy of the gross leak test specified in the standard, expounds the problems encountered in the process of the gross leak test, and gives solutions and precautions.

关 键 词：人工耳蜗植入系统 整体泄漏检测 刺激器 

分 类 号：R764[医药卫生—耳鼻咽喉科]