【英文标准名称】:Activeimplantablemedicaldevices-Particularrequirementsforcochlearandauditorybrainstemimplantsystems
【原文标准名称】:有源可植入医疗器械.耳蜗和听觉脑干植入系统的详细要求
【标准号】:BSEN45502-2-3-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2010-03-31
【实施或试行日期】:2010-03-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:听度;定义(术语);残疾;耳;电气工程;医用电气设备;电极;电医学;频率;听力(听觉保护);植入物(外科);输入阻抗;测量;测量技术;医用电子学;医疗技术学;包装件;感知;性能试验;额定值;安全性;灵敏度;规范(验收);刺激器;外科植入物;试验
【英文主题词】:Audiobility;Definitions;Disability;Ears;Electricalengineering;Electricalmedicalequipment;Electrodes;Electromedicine;Frequencies;Hearing(auditoryperception);Implants(surgical);Inputimpedance;Measurement;Measuringtechniques;Medicalelectronics;Medicaltechnology;Packages;Perception;Performancetests;Ratings;Safety;Sensitivity;Specification(approval);Stimulators;Surgicalimplants;Testing
【摘要】:ThisPart2-3ofEN45502specifiesrequirementsthatareapplicabletothoseACTIVEIMPLANTABLEMEDICALDEVICESthatareintendedtotreathearingimpairmentviaelectricalstimulationoftheauditorypathways.DeviceswhichtreathearingimpairmentviameansotherthanelectricalstimulationarenotcoveredbythisEuropeanStandard.TheteststhatarespecifiedinEN45502aretypetestsandaretobecarriedoutonsamplesofadevicetoshowcompliance.TheelectricalcharacteristicsoftheIMPLANTABLEPARTshallbedeterminedbyeithertheappropriatemethoddetailedinthisparticularstandardorbyanyothermethoddemonstratedtohaveanaccuracyequalto,orbetterthan,themethodspecified.Inthecaseofdispute,themethoddetailedinthisparticularstandardshallapply.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:48P;A4
【正文语种】:英语