·医疗卫生装备·2023年1月第44卷第1期ChineseMedicalEquipmentJournal·Vol．44·No．1·January·2023人工耳蜗植入体电极导线拉伸性评价方法研究陈甜甜，付丽，田佳，于哲，谭菲菲，张克*，丁锡燕（山东省医疗器械和药品包装检验研究院，济南250101）[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。[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[中国图书资料分类号]R318.6；TH777[文献标志码]A[文章编号]1003-8868（2023）01-0093-04DOI：10.19745/j.1003-8868.2023016StudyonevaluationmethodofelectrodeleadstretchabilityofcochlearimplantCHENTian-tian,FULi,TIANJia,YUZhe,TANFei-fei,ZHANGKe*,DINGXi-yan(ShandongInstituteofMedicalDeviceandPharmaceuticalPackagingInspection,Ji'nan250101,China)AbstractRelevantstandardsforcochlearimplantsandtheirrequirementsforelectrodeleadswereintroduced,andtheprocessofopen-circuittestingofstretchedcochlearimplantelectrodeleadsusingDCresistancemeasurementandimpedancetelemetrywasdescribed.Theresultsofmeasuringtheinsulationimpedanceofstretchedelectrodeleadsusinghigh-precisionmultimetermeasurementandoscilloscopemeasurementwerecompared,andtheeffectofsalinepretreatmentontheinsulationimpedanceofstretchedelectrodeleadswasverified.Methodologicalsuggestionswereproposedforevaluatingthetensilepropertiesofcochlearimplantelectrodeleads.Referencesandideaswereprovidedforinspectorsofrelatedproducts.[ChineseMedicalEquipmentJournal，2023，44（1）：93-96]Keywordscochlearimplant;electrodelead;stretchability;insulationtest;open-circuittesting0引言随着人类生活环境的变化，听力损失的患病率不断升高，其已成为全球重大的健康问题[1-2]。对于病变部位在内耳的重度/极重度感音神经性听力损失患者来说，人工耳蜗植入是目前听觉康复最可靠的选择[3-4]，也是获得和保持言语功能的最佳方案...
