【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.基本安全和基本性能的一般要求.补充标准.物理闭环控制器开发的要求
【标准号】:BSEN60601-1-10-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2008-08-29
【实施或试行日期】:2008-08-29
【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】:特性;闭环;控制器;定义;电器;电气工程;医用电气设备;电医学;设备;使用说明书;作标记;医疗设备;医学科学;医疗技术学;生理学的;生理学特性;安全;安全装置;安全要求;信号;规范(验收);测试
【英文主题词】:Characteristics;Closedloop;Controllers;Definition;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_01
【页数】:44P.;A4
【正文语种】:英语