ISO 14708-2-2005 外科植入物.有源可植入医疗装置.第2部分:心脏起搏器
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【英文标准名称】:Implantsforsurgery-Activeimplantablemedicaldevices-Part2:Cardiacpacemakers
【原文标准名称】:外科植入物.有源可植入医疗装置.第2部分:心脏起搏器
【标准号】:ISO14708-2-2005
【标准状态】:作废
【国别】:国际
【发布日期】:2005-10
【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;定义;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;间距;作标记;测量;医用电子学;医疗技术学;起搏器;包装件;感觉;性能试验;脉冲振幅;脉冲持续时间;脉冲发生器;额定值;安全;安全要求;灵敏度;规范(验收);试验;用户信息
【英文主题词】:bendtesting;definition;definitions;electricalengineering;electricalmedicalequipment;electrodes;electromedicine;frequencies;implants(surgical);inputimpedance;interval;marking;measurement;medicalelectronics;medicaltechnology;pacemakers;packages;perception;performancetests;pulseamplitude;pulsedurations;pulsegenerators;ratings;safety;safetyrequirements;sensitivity;specification(approval);surgicalimplants;testing;userinformation
【摘要】:ThisPart2specifiesrequirementsthatareapplicabletothoseACTIVEIMPLANTABLEMEDICALDEVICESintendedtotreatbradyarrhythmias.TheteststhatarespecifiedinISO14708aretypetests,andaretobecarriedoutonsamplesofadevicetoshowcompliance.ThisPart2isalsoapplicabletosomenon-implantablepartsandaccessoriesofthedevices(seeNote1).ThecharacteristicsoftheIMPLANTABLEPULSEGENERATORorLEADshallbedeterminedbyeithertheappropriatemethoddetailedinthisPart2orbyanyothermethoddemonstratedtohaveanaccuracyequalto,orbetterthan,themethodspecified.Inthecaseofdispute,themethoddetailedinthisPart2shallapply.AnyfeaturesofanACTIVEIMPLANTABLEMEDICALDEVICEintendedtotreattachyarrhythmiasarecoveredbyanotherISOdocumentunderdevelopment.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:96P.;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2部分:心脏起搏器
【标准号】:ISO14708-2-2005
【标准状态】:作废
【国别】:国际
【发布日期】:2005-10
【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;定义;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;间距;作标记;测量;医用电子学;医疗技术学;起搏器;包装件;感觉;性能试验;脉冲振幅;脉冲持续时间;脉冲发生器;额定值;安全;安全要求;灵敏度;规范(验收);试验;用户信息
【英文主题词】:bendtesting;definition;definitions;electricalengineering;electricalmedicalequipment;electrodes;electromedicine;frequencies;implants(surgical);inputimpedance;interval;marking;measurement;medicalelectronics;medicaltechnology;pacemakers;packages;perception;performancetests;pulseamplitude;pulsedurations;pulsegenerators;ratings;safety;safetyrequirements;sensitivity;specification(approval);surgicalimplants;testing;userinformation
【摘要】:ThisPart2specifiesrequirementsthatareapplicabletothoseACTIVEIMPLANTABLEMEDICALDEVICESintendedtotreatbradyarrhythmias.TheteststhatarespecifiedinISO14708aretypetests,andaretobecarriedoutonsamplesofadevicetoshowcompliance.ThisPart2isalsoapplicabletosomenon-implantablepartsandaccessoriesofthedevices(seeNote1).ThecharacteristicsoftheIMPLANTABLEPULSEGENERATORorLEADshallbedeterminedbyeithertheappropriatemethoddetailedinthisPart2orbyanyothermethoddemonstratedtohaveanaccuracyequalto,orbetterthan,themethodspecified.Inthecaseofdispute,themethoddetailedinthisPart2shallapply.AnyfeaturesofanACTIVEIMPLANTABLEMEDICALDEVICEintendedtotreattachyarrhythmiasarecoveredbyanotherISOdocumentunderdevelopment.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:96P.;A4
【正文语种】:英语
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