IEC 60601-2-39-2007 医用电气设备.第2-39部分:腹膜透析仪基本安全和基本性能的特殊要求
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【英文标准名称】:Medicalelectricalequipment-Part2-39:Particularrequirementsforbasicsafetyandessentialperformanceofperitonealdialysisequipment
【原文标准名称】:医用电气设备.第2-39部分:腹膜透析仪基本安全和基本性能的特殊要求
【标准号】:IEC60601-2-39-2007
【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/SC62D
【标准类型】:()
【标准水平】:()
【中文主题词】:协同形式;定义;透析;透析仪;电气设施;电气安全;环境条件;特点;家用设备;使用说明;医疗设备;医疗科学;医疗技术;最低要求;腹膜透析设备;安全;安全要求
【英文主题词】:Accompanyingforms;Definitions;Dialysis;Dialyzer;Electricalappliances;Electricalsafety;Environmentalconditions;Features;Hospitalequipment;Instructionsforuse;Medicalequipment;Medicalsciences;Medicaltechnology;Minimumrequirements;Peritonealdialysisequipments;Safety;Safetyrequirements
【摘要】:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofPERITONEALDIALYSISMEEQUIPMENTasdefinedin201.3.208,hereafterreferredtoasPDEQUIPMENT.ItappliestoPDEQUIPMENTintendedforuseeitherbymedicalstafforunderthesupervisionofmedicalexperts,includingPDEQUIPMENToperatedbythePATIENT,regardlessofwhetherthePDEQUIPMENTisusedinahospitalordomesticenvironment.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.NOTESeealso4.2ofthegeneralstandard.ThisstandardcanalsobeappliedtoPDEQUIPMENTusedforcompensationoralleviationofdisease,injuryordisability.TheseparticularrequirementsdonotapplytotheDIALYSINGSOLUTION,ortheDIALYSINGSOLUTIONCIRCUIT.
【中国标准分类号】:C37
【国际标准分类号】:11_040_60
【页数】:34P;A4
【正文语种】:英语
【原文标准名称】:医用电气设备.第2-39部分:腹膜透析仪基本安全和基本性能的特殊要求
【标准号】:IEC60601-2-39-2007
【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/SC62D
【标准类型】:()
【标准水平】:()
【中文主题词】:协同形式;定义;透析;透析仪;电气设施;电气安全;环境条件;特点;家用设备;使用说明;医疗设备;医疗科学;医疗技术;最低要求;腹膜透析设备;安全;安全要求
【英文主题词】:Accompanyingforms;Definitions;Dialysis;Dialyzer;Electricalappliances;Electricalsafety;Environmentalconditions;Features;Hospitalequipment;Instructionsforuse;Medicalequipment;Medicalsciences;Medicaltechnology;Minimumrequirements;Peritonealdialysisequipments;Safety;Safetyrequirements
【摘要】:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofPERITONEALDIALYSISMEEQUIPMENTasdefinedin201.3.208,hereafterreferredtoasPDEQUIPMENT.ItappliestoPDEQUIPMENTintendedforuseeitherbymedicalstafforunderthesupervisionofmedicalexperts,includingPDEQUIPMENToperatedbythePATIENT,regardlessofwhetherthePDEQUIPMENTisusedinahospitalordomesticenvironment.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.NOTESeealso4.2ofthegeneralstandard.ThisstandardcanalsobeappliedtoPDEQUIPMENTusedforcompensationoralleviationofdisease,injuryordisability.TheseparticularrequirementsdonotapplytotheDIALYSINGSOLUTION,ortheDIALYSINGSOLUTIONCIRCUIT.
【中国标准分类号】:C37
【国际标准分类号】:11_040_60
【页数】:34P;A4
【正文语种】:英语
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