BS EN 45502-2-2-2008 有源可植入医疗器件.用于治疗缓慢性心率失常的活性可植入医疗器件的特殊要求(心脏起搏器)
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【英文标准名称】:Activeimplantablemedicaldevices-Part2-2:Particularrequirementsforactiveimplantablemedicaldevicesintendedtotreattachyarrhythmia(includesimplantabledefibrillators)
【原文标准名称】:有源可植入医疗器件.用于治疗缓慢性心率失常的活性可植入医疗器件的特殊要求(心脏起搏器)
【标准号】:BSEN45502-2-2-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2008-10-31
【实施或试行日期】:2008-10-31
【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】:弯曲试验;连接件;去纤颤器;定义;尺寸;电气工程;医用电气设备;电极;电医学;频率;外科植入物;输入阻抗;铭刻;间隔;测量;测量技术;医用电子学;医学科学;医疗技术学;包装件;感知;性能试验;脉冲振幅;脉冲持续时间;脉冲能量;脉冲发生器;额定值;安全;灵敏度;规范(验收);试验
【英文主题词】:Bendtesting;Connections;Defibrillators;Definition;Definitions;Dimensions;Electricalengineering;Electricalmedicalequipment;Electrodes;Electromedicine;Frequencies;Implants(surgical);Inputimpedance;Inscription;Interval;Measurement;Measuringtechniques;Medicalelectronics;Medicalsciences;Medicaltechnology;Packages;Perception;Performancetests;Pulseamplitude;Pulsedurations;Pulseenergy;Pulsegenerators;Ratings;Safety;Sensitivity;Specification(approval);Surgicalimplants;Testing
【摘要】:ThisPart2-2ofEN45502specifiesrequirementsthatareapplicabletoIMPLANTABLECARDIOVERTERDEFIBRILLATORSandthefunctionsofACTIVEIMPLANTABLEMEDICALDEVICESintendedtotreattachyarrhythmia.TheteststhatarespecifiedinEN45502aretypetestsandaretobecarriedoutonsamplesofadevicetoshowcompliance.ThispartofEN45502isalsoapplicabletosomenon-implantablepartsandaccessoriesofthedevices(seeNote1).ThecharacteristicsoftheIMPLANTABLEPULSEGENERATORorLEADshallbedeterminedbyeithertheappropriatemethoddetailedinthisparticularstandardorbyanyothermethoddemonstratedtohaveaccuracyequalto,orbetterthan,themethodspecified.Inthecaseofdispute,themethoddetailedinthisParticularStandardshallapply.AnyaspectofanACTIVEIMPLANTABLEMEDICALDEVICEintendedtotreatbradyarrhythmiasiscoveredbyEN45502–2-1Particularrequirementsforactiveimplantablemedicaldevicesintendedtotreatbradyarrhythmia(Pacemakers).NOTE1ThedevicethatiscommonlyreferredtoasanACTIVEIMPLANTABLEMEDICALDEVICEmayinfactbeasingledevice,acombinationofdevices,oracombinationofadeviceordevicesandoneormoreaccessories.Notallofthesepartsarerequiredtobeeitherpartiallyortotallyimplantable,butthereisaneedtospecifysomerequirementsofnon-implantablepartsandaccessoriesiftheycouldaffectthesafetyorperformanceoftheimplantabledevice.NOTE2TheterminologyusedinthisEuropeanStandardisintendedtobeconsistentwiththeterminologyofDirective90/385/EEC.NOTE3InthisEuropeanStandard,termsprintedinsmallcapitallettersareusedasdefinedinClause3.Whereadefinedtermisusedasaqualifierinanotherterm,itisnotprintedinsmallcapitallettersunlesstheconceptthusqualifiedisalsodefined.NOTE4Particularrequirementsforcongestiveheartfailuredevicesareunderconsideration.Thesetypesofdevicesarenotcoveredbythisstandard.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:108P.;A4
【正文语种】:英语
【原文标准名称】:有源可植入医疗器件.用于治疗缓慢性心率失常的活性可植入医疗器件的特殊要求(心脏起搏器)
【标准号】:BSEN45502-2-2-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2008-10-31
【实施或试行日期】:2008-10-31
【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】:弯曲试验;连接件;去纤颤器;定义;尺寸;电气工程;医用电气设备;电极;电医学;频率;外科植入物;输入阻抗;铭刻;间隔;测量;测量技术;医用电子学;医学科学;医疗技术学;包装件;感知;性能试验;脉冲振幅;脉冲持续时间;脉冲能量;脉冲发生器;额定值;安全;灵敏度;规范(验收);试验
【英文主题词】:Bendtesting;Connections;Defibrillators;Definition;Definitions;Dimensions;Electricalengineering;Electricalmedicalequipment;Electrodes;Electromedicine;Frequencies;Implants(surgical);Inputimpedance;Inscription;Interval;Measurement;Measuringtechniques;Medicalelectronics;Medicalsciences;Medicaltechnology;Packages;Perception;Performancetests;Pulseamplitude;Pulsedurations;Pulseenergy;Pulsegenerators;Ratings;Safety;Sensitivity;Specification(approval);Surgicalimplants;Testing
【摘要】:ThisPart2-2ofEN45502specifiesrequirementsthatareapplicabletoIMPLANTABLECARDIOVERTERDEFIBRILLATORSandthefunctionsofACTIVEIMPLANTABLEMEDICALDEVICESintendedtotreattachyarrhythmia.TheteststhatarespecifiedinEN45502aretypetestsandaretobecarriedoutonsamplesofadevicetoshowcompliance.ThispartofEN45502isalsoapplicabletosomenon-implantablepartsandaccessoriesofthedevices(seeNote1).ThecharacteristicsoftheIMPLANTABLEPULSEGENERATORorLEADshallbedeterminedbyeithertheappropriatemethoddetailedinthisparticularstandardorbyanyothermethoddemonstratedtohaveaccuracyequalto,orbetterthan,themethodspecified.Inthecaseofdispute,themethoddetailedinthisParticularStandardshallapply.AnyaspectofanACTIVEIMPLANTABLEMEDICALDEVICEintendedtotreatbradyarrhythmiasiscoveredbyEN45502–2-1Particularrequirementsforactiveimplantablemedicaldevicesintendedtotreatbradyarrhythmia(Pacemakers).NOTE1ThedevicethatiscommonlyreferredtoasanACTIVEIMPLANTABLEMEDICALDEVICEmayinfactbeasingledevice,acombinationofdevices,oracombinationofadeviceordevicesandoneormoreaccessories.Notallofthesepartsarerequiredtobeeitherpartiallyortotallyimplantable,butthereisaneedtospecifysomerequirementsofnon-implantablepartsandaccessoriesiftheycouldaffectthesafetyorperformanceoftheimplantabledevice.NOTE2TheterminologyusedinthisEuropeanStandardisintendedtobeconsistentwiththeterminologyofDirective90/385/EEC.NOTE3InthisEuropeanStandard,termsprintedinsmallcapitallettersareusedasdefinedinClause3.Whereadefinedtermisusedasaqualifierinanotherterm,itisnotprintedinsmallcapitallettersunlesstheconceptthusqualifiedisalsodefined.NOTE4Particularrequirementsforcongestiveheartfailuredevicesareunderconsideration.Thesetypesofdevicesarenotcoveredbythisstandard.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:108P.;A4
【正文语种】:英语
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