BS EN 62353-2008 医疗电气设备.医疗电气设备的循环试验和维修后试验

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【英文标准名称】:Medicalelectricalequipment-Recurrenttestandtestafterrepairofmedicalelectricalequipment
【原文标准名称】:医疗电气设备.医疗电气设备的循环试验和维修后试验
【标准号】:BSEN62353-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2008-05-30
【实施或试行日期】:2008-05-30
【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】:事故预防;交付使用;定义;设计;接地导线;接地;电接触保护;电力系统;电器;电气工程;电气设备;医用电气设备;电气保护设备;电气安全;电驱动装置;电磁兼容性;电医学;EMC;设备安全;检验(质量保证);检验;仪器;漏电;泄漏电流测量;泄漏电流;维修;测量;机械安全;医疗设备;医学科学;医疗技术学;职业安全;防电击;检修;重复试验;连接器电阻;安全;安全装置;安全工程;安全要求;规范(验收);测试;测试条件;工作场所安全
【英文主题词】:Accidentprevention;Commissioning;Definition;Definitions;Design;Earthconductors;Earthing;Electricappliances;Electriccontactprotection;Electricpowersystems;Electricalappliances;Electricalengineering;Electricalequipment;Electricalmedicalequipment;Electricalprotectionequipment;Electricalsafety;Electrically-operateddevices;Electromagneticcompatibility;Electromedicine;EMC;Equipmentsafety;Examination(qualityassurance);Inspection;Instruments;Leakagecurrent;Leakagecurrentmeasurement;Leakagecurrents;Maintenance;Measurement;Mechanicalsafety;Medicalequipment;Medicalsciences;Medicaltechnology;Occupationalsafety;Protectionagainstelectricshocks;Repair;Repeattests;Resistanceofconductor;Safety;Safetydevices;Safetyengineering;Safetyrequirements;Specification(approval);Testing;Testingconditions;Workplacesafety
【摘要】:ThisInternationalStandardappliestotestingofMEDICALELECTRICALEQUIPMENTandMEDICALELECTRICALSYSTEMS,hereafterreferredtoasMEEQUIPMENTandMESYSTEMS,orpartsofsuchequipmentorsystems,whichcomplywithIEC60601-1,beforePUTTINGINTOSERVICE,duringMAINTENANCE,INSPECTION,SERVICINGandafterREPAIRoronoccasionofRECURRENTTESTStoassessthesafetyofsuchMEEQUIPMENTorMESYSTEMSorpartsthereof.ForequipmentnotbuilttoIEC60601-1theserequirementsmaybeusedtakingintoaccountthesafetystandardsforthedesignandinformationintheinstructionsforuseofthatequipment.ThisstandardcontainstableswithallowablevaluesrelatingtodifferenteditionsofIEC60601-1.Forthepurposeofthisstandard,theapplicationofmeasuringmethodsisindependentoftheeditionaccordingtowhichtheMEEQUIPMENTORMESYSTEMisdesigned.Thisstandardcontains:–"generalrequirements",whichcontainclausesofgeneralconcern,and–"particularrequirements",furtherclauseshandlingspecialtypesofMEEQUIPMENTorMESYSTEMSandapplyinginconnectionwiththe"Generalrequirements".NOTE1Atthisstage,therearenoparticularrequirements.ThisstandardisnotsuitabletoassesswhetherMEEQUIPMENTorMESYSTEMSoranyotherequipmentcomplywiththerelevantstandardsfortheirdesign.ThisstandarddoesnotdefinerequirementsforREPAIR,exchangeofcomponentsandMODIFICATIONofMEEQUIPMENTorMESYSTEMS.NOTE2AllMAINTENANCE,INSPECTION,SERVICING,andREPAIRdoneinaccordancewithMANUFACTURER'sinstructionsmaintaintheconformitytothestandardusedforthedesignoftheequipment.Otherwiseconformitytoapplicablerequirementshavetobeassessedandverified.ThisstandardisalsoapplicabletotestsafterREPAIR.ThetestingshallbedefinedaccordingtotheextentofworkperformedandapplicableguidancefromtheMANUFACTURER.ThisstandardisnotintendedtodefinetimeintervalsforRECURRENTTESTS.IfsuchintervalsarenotdefinedbytheMANUFACTURER,AnnexFmaybeusedtohelpestablishsuchintervals.
【中国标准分类号】:C37
【国际标准分类号】:11_040_01
【页数】:56P.;A4
【正文语种】:英语