人工耳蜗植入系统的环境适应性检测方法研究  

Research on testing methods of environmental suitability of cochlear implant system

作　　者：张在爱 陈甜甜 田佳 蒋硕 付丽 刘斌 张克 ZHANG Zai-ai;CHEN Tian-tian;TIAN Jia;JIANG Shuo;FU Li;LIU Bin;ZHANG Ke(Shandong Institute of Medical Device and Pharmaceutical Packing Inspection,NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices,Ji'nan 250101,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院,国家药品监督管理局生物材料器械安全性评价重点实验室,济南250101

出　　处：《医疗卫生装备》2022年第10期81-83,94,共4页Chinese Medical Equipment Journal

摘　　要：介绍了人工耳蜗植入系统的标准执行情况,分析了在评价人工耳蜗植入系统的环境适应性过程中遇到的问题,提出了一种辅助检测装置及其测试方法,解决了由于人工耳蜗植入体与人工耳蜗声音处理器的设计工作环境温度不同而导致在低温环境下测试失败的问题,为人工耳蜗植入系统的环境适应性检测提供了参考。The implementation of standards for the cochlear implant systems was introduced,and the problems encountered in the process of evaluating the environmental suitability of the cochlear implant system were analyzed.An auxiliary testing device and its testing method were proposed to treat the test failure in low temperature environment due to different designed operating temperature of the cochlear implant and cochlear speech processor.References were provided for environmental suitability testing of the cochlear implant system.

关 键 词：人工耳蜗植入系统 人工耳蜗植入体 声音处理器 环境适应性检测 

分 类 号：R318.6[医药卫生—生物医学工程] R764.5[医药卫生—基础医学]