BS EN 45502-2-1-2004 活性可植入医疗设备.用于治疗缓慢性心率失常的活性可植入医疗器件的详细要求(心脏起搏器)
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【英文标准名称】:Activeimplantablemedicaldevices-Particularrequirementsforactiveimplantablemedicaldevicesintendedtotreatbradyarrhythmia(cardiacpacemakers)
【原文标准名称】:活性可植入医疗设备.用于治疗缓慢性心率失常的活性可植入医疗器件的详细要求(心脏起搏器)
【标准号】:BSEN45502-2-1-2004
【标准状态】:现行
【国别】:英国
【发布日期】:2004-01-20
【实施或试行日期】:2004-01-20
【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】:弯曲试验;定义;定义(术语);电气工程;医用电气设备;电极;电医学;频率;植入物(外科);输入阻抗;铭刻;间隔;测量;医用电子学;医疗技术学;起搏器;包装件;感知;性能试验;脉冲振幅;脉冲持续时间;脉冲发生器;额定值;安全性;灵敏度;规范(验收);外科植入物;试验
【英文主题词】:Bendtesting;Definition;Definitions;Electricalengineering;Electricalmedicalequipment;Electrodes;Electromedicine;Frequencies;Implants(surgical);Inputimpedance;Inscription;Interval;Measurement;Medicalelectronics;Medicaltechnology;Pacemakers;Packages;Perception;Performancetests;Pulseamplitude;Pulsedurations;Pulsegenerators;Ratings;Safety;Sensitivity;Specification(approval);Surgicalimplants;Testing
【摘要】:ThisPart2-1specifiesrequirementsthatareapplicabletothoseACTIVEIMPLANTABLEMEDICALDEVICESintendedtotreatbradyarrhythmias.TheteststhatarespecifiedinEN45502aretypetests,andaretobecarriedoutonsamplesofadevicetoshowcompliance.ThisPart2-1isalsoapplicabletosomenon-implantablepartsandaccessoriesofthedevices(seeNote1).ThecharacteristicsoftheIMPLANTABLEPULSEGENERATORorLEADshallbedeterminedbyeithertheappropriatemethoddetailedinthisPart2-1orbyanyothermethoddemonstratedtohaveanaccuracyequalto,orbetterthan,themethodspecified.Inthecaseofdispute,themethoddetailedinthisPart2-1shallapply.AnyfeaturesofanACTIVEIMPLANTABLEMEDICALDEVICEintendedtotreattachyarrhythmiasarecoveredbyEN45502?2-2.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:98P;A4
【正文语种】:英语
【原文标准名称】:活性可植入医疗设备.用于治疗缓慢性心率失常的活性可植入医疗器件的详细要求(心脏起搏器)
【标准号】:BSEN45502-2-1-2004
【标准状态】:现行
【国别】:英国
【发布日期】:2004-01-20
【实施或试行日期】:2004-01-20
【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】:弯曲试验;定义;定义(术语);电气工程;医用电气设备;电极;电医学;频率;植入物(外科);输入阻抗;铭刻;间隔;测量;医用电子学;医疗技术学;起搏器;包装件;感知;性能试验;脉冲振幅;脉冲持续时间;脉冲发生器;额定值;安全性;灵敏度;规范(验收);外科植入物;试验
【英文主题词】:Bendtesting;Definition;Definitions;Electricalengineering;Electricalmedicalequipment;Electrodes;Electromedicine;Frequencies;Implants(surgical);Inputimpedance;Inscription;Interval;Measurement;Medicalelectronics;Medicaltechnology;Pacemakers;Packages;Perception;Performancetests;Pulseamplitude;Pulsedurations;Pulsegenerators;Ratings;Safety;Sensitivity;Specification(approval);Surgicalimplants;Testing
【摘要】:ThisPart2-1specifiesrequirementsthatareapplicabletothoseACTIVEIMPLANTABLEMEDICALDEVICESintendedtotreatbradyarrhythmias.TheteststhatarespecifiedinEN45502aretypetests,andaretobecarriedoutonsamplesofadevicetoshowcompliance.ThisPart2-1isalsoapplicabletosomenon-implantablepartsandaccessoriesofthedevices(seeNote1).ThecharacteristicsoftheIMPLANTABLEPULSEGENERATORorLEADshallbedeterminedbyeithertheappropriatemethoddetailedinthisPart2-1orbyanyothermethoddemonstratedtohaveanaccuracyequalto,orbetterthan,themethodspecified.Inthecaseofdispute,themethoddetailedinthisPart2-1shallapply.AnyfeaturesofanACTIVEIMPLANTABLEMEDICALDEVICEintendedtotreattachyarrhythmiasarecoveredbyEN45502?2-2.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:98P;A4
【正文语种】:英语
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