ISO 14708-6-2010 外科植入物.有源可植入医疗装置.第6部分:用于治疗快速性心律失常(包括可植入去纤颤器)有源植入式医疗器件的特殊要求
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【英文标准名称】:Implantsforsurgery-Activeimplantablemedicaldevices-Part6:Particularrequirementsforactiveimplantablemedicaldevicesintendedtotreattachyarrhythmia(includingimplantabledefibrillators)
【原文标准名称】:外科植入物.有源可植入医疗装置.第6部分:用于治疗快速性心律失常(包括可植入去纤颤器)有源植入式医疗器件的特殊要求
【标准号】:ISO14708-6-2010
【标准状态】:现行
【国别】:国际
【发布日期】:2010-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC150
【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;批注;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;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】:ThispartofISO14708specifiesrequirementsthatareapplicabletoIMPLANTABLECARDIOVERTERDEFIBRILLATORSandthefunctionsofACTIVEIMPLANTABLEMEDICALDEVICESintendedtotreattachyarrhythmia.TheteststhatarespecifiedinISO14708aretypetestsandaretobecarriedoutonsamplesofadevicetoshowcompliance.ThispartofISO14708isalsoapplicabletosomenon-implantablepartsandaccessoriesofthedevices(seeNote1).ThecharacteristicsoftheIMPLANTABLEPULSEGENERATORorLEADshallbedeterminedbyeithertheappropriatemethoddetailedinthispartofISO14708orbyanyothermethoddemonstratedtohaveaccuracyequalto,orbetterthan,themethodspecified.Inthecaseofdispute,themethoddetailedinthispartofISO14708shallapply.AnyaspectofanACTIVEIMPLANTABLEMEDICALDEVICEintendedtotreatbradyarrhythmiasiscoveredbyISO14708-2.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:120P.;A4
【正文语种】:英语
【原文标准名称】:外科植入物.有源可植入医疗装置.第6部分:用于治疗快速性心律失常(包括可植入去纤颤器)有源植入式医疗器件的特殊要求
【标准号】:ISO14708-6-2010
【标准状态】:现行
【国别】:国际
【发布日期】:2010-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC150
【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;批注;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;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】:ThispartofISO14708specifiesrequirementsthatareapplicabletoIMPLANTABLECARDIOVERTERDEFIBRILLATORSandthefunctionsofACTIVEIMPLANTABLEMEDICALDEVICESintendedtotreattachyarrhythmia.TheteststhatarespecifiedinISO14708aretypetestsandaretobecarriedoutonsamplesofadevicetoshowcompliance.ThispartofISO14708isalsoapplicabletosomenon-implantablepartsandaccessoriesofthedevices(seeNote1).ThecharacteristicsoftheIMPLANTABLEPULSEGENERATORorLEADshallbedeterminedbyeithertheappropriatemethoddetailedinthispartofISO14708orbyanyothermethoddemonstratedtohaveaccuracyequalto,orbetterthan,themethodspecified.Inthecaseofdispute,themethoddetailedinthispartofISO14708shallapply.AnyaspectofanACTIVEIMPLANTABLEMEDICALDEVICEintendedtotreatbradyarrhythmiasiscoveredbyISO14708-2.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:120P.;A4
【正文语种】:英语
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