BS EN 60601-2-39-2008 医疗电气设备.腹膜透析设备的基本安全和重要性能的特殊要求
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【英文标准名称】:Medicalelectricalequipment—Part2-39:Particularrequirementsforbasicsafetyandessentialperformanceofperitonealdialysisequipment
【原文标准名称】:医疗电气设备.腹膜透析设备的基本安全和重要性能的特殊要求
【标准号】:BSEN60601-2-39-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2009-03-31
【实施或试行日期】:2009-03-31
【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】:随附表格;定义;渗析;透析器;电器;电气安全;环境条件;特点;医院设备;使用说明书;医疗设备;医学科学;医疗技术学;最低要求;腹膜透析设备;安全;安全要求
【英文主题词】:Accompanyingforms;Definition;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.
【中国标准分类号】:C37
【国际标准分类号】:11_040_99
【页数】:26P.;A4
【正文语种】:英语
【原文标准名称】:医疗电气设备.腹膜透析设备的基本安全和重要性能的特殊要求
【标准号】:BSEN60601-2-39-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2009-03-31
【实施或试行日期】:2009-03-31
【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】:随附表格;定义;渗析;透析器;电器;电气安全;环境条件;特点;医院设备;使用说明书;医疗设备;医学科学;医疗技术学;最低要求;腹膜透析设备;安全;安全要求
【英文主题词】:Accompanyingforms;Definition;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.
【中国标准分类号】:C37
【国际标准分类号】:11_040_99
【页数】:26P.;A4
【正文语种】:英语
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