IEC 60601-1-10-2007 医用电气设备.第1-10部分:基本安全和基本性能的一般要求.补充标准:生理闭环控制器开发的要求
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【英文标准名称】:Medicalelectricalequipment-Part1-10:Generalrequirementsforbasicsafetyandessentialperformance-CollateralStandard:Requirementsforthedevelopmentofphysiologicclosed-loopcontrollers
【原文标准名称】:医用电气设备.第1-10部分:基本安全和基本性能的一般要求.补充标准:生理闭环控制器开发的要求
【标准号】:IEC60601-1-10-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-11
【实施或试行日期】:
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/SC62A
【标准类型】:()
【标准水平】:()
【中文主题词】:特点;闭合;控制器;定义;电器;电气工程;电疗设备;电疗;设备;使用说明;做标记;医疗设备;医疗科学;医疗技术;生理的;生理特性;安全;安全设备;信号;规范(验收);测试
【英文主题词】:Characteristics;Closedloop;Controllers;Definitions;Electricappliances;Electricalappliances;Electricalengineering;Electricalmedicalequipment;Electromedicine;Equipment;Instructionsforuse;Marking;Medicalequipment;Medicalsciences;Medicaltechnology;Physiological;Physiologicalproperty;Safety;Safetydevices;Safetyrequirements;Signals;Specification(approval);Testing
【摘要】:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofMEDICALELECTRICALEQUIPMENTandMEDICALELECTRICALSYSTEMS,hereafterreferredtoasMEEQUIPMENTandMESYSTEMS.Thiscollateralstandardspecifiesrequirementsforthedevelopment(analysis,design,VERIFICATIONandVALIDATION)ofaPHYSIOLOGICCLOSED-LOOPCONTROLLER(PCLC)aspartofaPHYSIOLOGICCLOSED-LOOPCONTROLSYSTEM(PCLCS)inMEEQUIPMENTandMESYSTEMStocontrolaPHYSIOLOGICVARIABLE.NOTEAPHYSIOLOGICVARIABLEcanbeabodychemistry(e.g.electrolytes,bloodglucose),aphysicalproperty(e.g.PATIENTtemperature,electrophysiologic,hemodynamic),orapharmaceuticalconcentration.ThiscollateralstandardappliestovarioustypesofPCLC,e.g.linearandnon-linear,adaptive,fuzzy,neuralnetworks.Thiscollateralstandarddoesnotspecify:?additionalmechanicalrequirements;or?additionalelectricalrequirements.Thiscollateralstandardappliestoaclosed-loopcontroller(seeFigure1)thatsetstheCONTROLLEROUTPUTVARIABLEinordertoadjust(i.e.,changeormaintain)themeasuredPHYSIOLOGICVARIABLEbyrelatingittotheREFERENCEVARIABLE.Aclosed-loopcontrollerthatmaintainsaphysicalorchemicalVARIABLE,usingfeedbackthatisnotmeasuredfromaPATIENT,isoutsidethescopeofthisstandard.
【中国标准分类号】:C37
【国际标准分类号】:11_040;11_040_55
【页数】:79P;A4
【正文语种】:英语
【原文标准名称】:医用电气设备.第1-10部分:基本安全和基本性能的一般要求.补充标准:生理闭环控制器开发的要求
【标准号】:IEC60601-1-10-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-11
【实施或试行日期】:
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/SC62A
【标准类型】:()
【标准水平】:()
【中文主题词】:特点;闭合;控制器;定义;电器;电气工程;电疗设备;电疗;设备;使用说明;做标记;医疗设备;医疗科学;医疗技术;生理的;生理特性;安全;安全设备;信号;规范(验收);测试
【英文主题词】:Characteristics;Closedloop;Controllers;Definitions;Electricappliances;Electricalappliances;Electricalengineering;Electricalmedicalequipment;Electromedicine;Equipment;Instructionsforuse;Marking;Medicalequipment;Medicalsciences;Medicaltechnology;Physiological;Physiologicalproperty;Safety;Safetydevices;Safetyrequirements;Signals;Specification(approval);Testing
【摘要】:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofMEDICALELECTRICALEQUIPMENTandMEDICALELECTRICALSYSTEMS,hereafterreferredtoasMEEQUIPMENTandMESYSTEMS.Thiscollateralstandardspecifiesrequirementsforthedevelopment(analysis,design,VERIFICATIONandVALIDATION)ofaPHYSIOLOGICCLOSED-LOOPCONTROLLER(PCLC)aspartofaPHYSIOLOGICCLOSED-LOOPCONTROLSYSTEM(PCLCS)inMEEQUIPMENTandMESYSTEMStocontrolaPHYSIOLOGICVARIABLE.NOTEAPHYSIOLOGICVARIABLEcanbeabodychemistry(e.g.electrolytes,bloodglucose),aphysicalproperty(e.g.PATIENTtemperature,electrophysiologic,hemodynamic),orapharmaceuticalconcentration.ThiscollateralstandardappliestovarioustypesofPCLC,e.g.linearandnon-linear,adaptive,fuzzy,neuralnetworks.Thiscollateralstandarddoesnotspecify:?additionalmechanicalrequirements;or?additionalelectricalrequirements.Thiscollateralstandardappliestoaclosed-loopcontroller(seeFigure1)thatsetstheCONTROLLEROUTPUTVARIABLEinordertoadjust(i.e.,changeormaintain)themeasuredPHYSIOLOGICVARIABLEbyrelatingittotheREFERENCEVARIABLE.Aclosed-loopcontrollerthatmaintainsaphysicalorchemicalVARIABLE,usingfeedbackthatisnotmeasuredfromaPATIENT,isoutsidethescopeofthisstandard.
【中国标准分类号】:C37
【国际标准分类号】:11_040;11_040_55
【页数】:79P;A4
【正文语种】:英语
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