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【英文标准名称】:Medicalelectricalequipment-Part2-58:Particularrequirementsforbasicsafetyandessentialperformanceoflensremovaldevicesandvitrectomydevicesforophthalmicsurgery
【原文标准名称】:医疗电气设备.第2-58部分:眼科手术用晶状体移除装置和玻璃体切除装置基本安全性和重要性能的详细要求
【标准号】:IEC80601-2-58-2008
【标准状态】:现行
【国别】:国际
【发布日期】:2008-10-01
【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】:基本安全性;控制;定义;诊断设备;电器;电气工程;医用电气设备;电气保护设备;电气安全;电医学;目镜;眼;红外线辐射;检验;使用说明书;透镜;机械安全;医疗设备;医学科学;医疗技术学;眼科设备;眼科光学;眼科学;保护装置;视网膜;安全性;安全工程;安全性要求;规范(验收);外科学;手术器械;试验;玻璃体切除术
【英文主题词】:Basicsafety;Controls;Definitions;Diagnosticequipment;Electricappliances;Electricalengineering;Electricalmedicalequipment;Electricalprotectionequipment;Electricalsafety;Electromedicine;Eyepieces;Eyes;Infraredradiation;Inspection;Instructionsforuse;Lenses;Mechanicalsafety;Medicaldevices;Medicalequipment;Medicalscience;Medicalsciences;Medicaltechnology;Ophthalmicequipment;Ophthalmicoptics;Ophthalmology;Protectivedevices;Retina;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Surgery;Surgicalinstruments;Testing;Vitrectomy
【摘要】:Replacement:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofLENSREMOVALDEVICESandVITRECTOMYDEVICESforophthalmicsurgery(asdefinedin201.3.208and201.3.217)andassociatedACCESSORIESthatcanbeconnectedtothisMEDICALELECTRICALEQUIPMENT,hereafterreferredtoasMEEQUIPMENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.NOTESeealso4.2ofthegeneralstandard.
【中国标准分类号】:C32
【国际标准分类号】:11_040_70
【页数】:53P;A4
【正文语种】:英语