BS EN 60601-2-43-2010 医用电气设备.介入治疗用X射线设备的基本安全性和必要性能的详细要求
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【英文标准名称】:Medicalelectricalequipment-ParticularrequirementsforbasicsafetyandessentialperformanceofX-rayequipmentforinterventionalprocedures
【原文标准名称】:医用电气设备.介入治疗用X射线设备的基本安全性和必要性能的详细要求
【标准号】:BSEN60601-2-43-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2010-07-31
【实施或试行日期】:2010-07-31
【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】:心脏病学;分类系统;计算机断层摄影;定义;牙科学;电气工程;医用电气设备;电气保护设备;电医学;使用说明书;辐照器;乳腺X射线摄影术;作标记;医疗设备;医学放射学;医学科学;医疗技术学;操作说明书;性能要求;防电击;辐射防护;放射疗法;安全;安全要求;规范(验收);术语;治疗学;X射线仪;X射线设备;X射线检测;X射线发生器;X射线
【英文主题词】:Cardiology;Classificationsystems;Computedtomography;Definitions;Dentistry;Electricalengineering;Electricalmedicalequipment;Electricalprotectionequipment;Electromedicine;Instructionsforuse;Irradiationapparatus;Mammography;Marking;Medicalequipment;Medicalradiology;Medicalsciences;Medicaltechnology;Operationalinstructions;Performancerequirements;Protectionagainstelectricshocks;Radiationprotection;Radiotherapy;Safety;Safetyrequirements;Specification(approval);Terms;Therapeutics;X-rayapparatus;X-rayequipment;X-rayexamination;X-raygenerators;X-rays
【摘要】:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofX-RAYEQUIPMENTdeclaredbytheMANUFACTURERtobesuitableforRADIOSCOPICALLYGUIDEDINTERVENTIONALPROCEDURES,hereafterreferredtoasINTERVENTIONALX-RAYEQUIPMENT.Itsscopeexcludes,inparticular:–equipmentforRADIOTHERAPY;–equipmentforCOMPUTEDTOMOGRAPHY;–ACCESSORIESintendedtobeintroducedintothePATIENT;–mammographicX-RAYEQUIPMENT;–dentalX-RAYEQUIPMENT.INTERVENTIONALX-RAYEQUIPMENTdeclaredbytheMANUFACTURERtobesuitableforRADIOSCOPICALLYGUIDEDINTERVENTIONALPROCEDURES,whichdoesnotincludeaPATIENTSUPPORTaspartofthesystem,isexemptfromthePATIENTSUPPORTprovisionsofthisstandard.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoINTERVENTIONALX-RAYEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoINTERVENTIONALX-RAYEQUIPMENTandtoMESYSTEMS,asrelevant.
【中国标准分类号】:C43
【国际标准分类号】:11_040_50;37_040_25
【页数】:58P.;A4
【正文语种】:英语
【原文标准名称】:医用电气设备.介入治疗用X射线设备的基本安全性和必要性能的详细要求
【标准号】:BSEN60601-2-43-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2010-07-31
【实施或试行日期】:2010-07-31
【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】:心脏病学;分类系统;计算机断层摄影;定义;牙科学;电气工程;医用电气设备;电气保护设备;电医学;使用说明书;辐照器;乳腺X射线摄影术;作标记;医疗设备;医学放射学;医学科学;医疗技术学;操作说明书;性能要求;防电击;辐射防护;放射疗法;安全;安全要求;规范(验收);术语;治疗学;X射线仪;X射线设备;X射线检测;X射线发生器;X射线
【英文主题词】:Cardiology;Classificationsystems;Computedtomography;Definitions;Dentistry;Electricalengineering;Electricalmedicalequipment;Electricalprotectionequipment;Electromedicine;Instructionsforuse;Irradiationapparatus;Mammography;Marking;Medicalequipment;Medicalradiology;Medicalsciences;Medicaltechnology;Operationalinstructions;Performancerequirements;Protectionagainstelectricshocks;Radiationprotection;Radiotherapy;Safety;Safetyrequirements;Specification(approval);Terms;Therapeutics;X-rayapparatus;X-rayequipment;X-rayexamination;X-raygenerators;X-rays
【摘要】:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofX-RAYEQUIPMENTdeclaredbytheMANUFACTURERtobesuitableforRADIOSCOPICALLYGUIDEDINTERVENTIONALPROCEDURES,hereafterreferredtoasINTERVENTIONALX-RAYEQUIPMENT.Itsscopeexcludes,inparticular:–equipmentforRADIOTHERAPY;–equipmentforCOMPUTEDTOMOGRAPHY;–ACCESSORIESintendedtobeintroducedintothePATIENT;–mammographicX-RAYEQUIPMENT;–dentalX-RAYEQUIPMENT.INTERVENTIONALX-RAYEQUIPMENTdeclaredbytheMANUFACTURERtobesuitableforRADIOSCOPICALLYGUIDEDINTERVENTIONALPROCEDURES,whichdoesnotincludeaPATIENTSUPPORTaspartofthesystem,isexemptfromthePATIENTSUPPORTprovisionsofthisstandard.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoINTERVENTIONALX-RAYEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoINTERVENTIONALX-RAYEQUIPMENTandtoMESYSTEMS,asrelevant.
【中国标准分类号】:C43
【国际标准分类号】:11_040_50;37_040_25
【页数】:58P.;A4
【正文语种】:英语
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