人工耳蜗植入体电极导线拉伸性评价方法研究  

Study on evaluation method of electrode lead stretchability of cochlear implant

作　　者：陈甜甜 付丽 田佳 于哲 谭菲菲 张克 丁锡燕 CHEN Tian-tian;FU Li;TIAN Jia;YU Zhe;TAN Fei-fei;ZHANG Ke;DING Xi-yan(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,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,济南250101

出　　处：《医疗卫生装备》2023年第1期93-96,共4页Chinese Medical Equipment Journal

摘　　要：介绍了人工耳蜗植入体相关标准及其对电极导线的相关要求,阐述了采用直流电阻测试法和阻抗遥测法对拉伸后的人工耳蜗植入体电极导线进行开路试验的过程,比较了采用高精度万用表测量法和示波器测量法测量拉伸后的电极导线绝缘阻抗的结果,验证了盐水预处理对拉伸后的电极导线绝缘阻抗的影响,并给出了人工耳蜗植入体电极导线拉伸性评价的方法建议,为相关产品的检验人员提供了参考和思路。Relevant standards for cochlear implants and their requirements for electrode leads were introduced, and the process of open-circuit testing of stretched cochlear implant electrode leads using DC resistance measurement and impedance telemetry was described. The results of measuring the insulation impedance of stretched electrode leads using high-precision multimeter measurement and oscilloscope measurement were compared, and the effect of saline pretreatment on the insulation impedance of stretched electrode leads was verified. Methodological suggestions were proposed for evaluating the tensile properties of cochlear implant electrode leads. References and ideas were provided for inspectors of related products.

关 键 词：人工耳蜗植入体 电极导线 拉伸性 绝缘试验 开路试验 

分 类 号：R318.6[医药卫生—生物医学工程] TH777[医药卫生—基础医学]