IEC-60601-1-4-检查表-中英文版

TESTREPORTIEC60601-1-4MedicalelectricequipmentPart1-4:GeneralrequirementsforsafetyCollateralStandard:ProgrammableelectricalmedicalsystemsReportreferenceNo.........................:×××Compiledby(+signature)................:.....................................................Reviewedby(+signature)...............:.....................................................Dateofissue.....................................:Jan18,2010Applicant..........................................:Address.............................................:Standard............................................:601-1-4TestReportFormNo........................:I601-1_C/97-04TRFOriginator.................................:UnderwritersLaboratoriesInc.MasterTRF......................................:dated97-04Copyrightblanktestreport...............:ThebodiesparticipatingintheCommitteeofCertificationBodies(CCB).ThisreportisbasedonablanktestreportthatwaspreparedbyKEMAusinginformationobtainedfromtheTRForiginator.Testprocedure..................................:TestreportonlyProceduredeviation..........................:N/ANon-standardtestmethod.................:N/ATypeoftestobject............................:Trademark........................................:Model/typereference........................:Manufacturer....................................:Address.............................................:Rating...............................................:Page2of15ReportNo.XXXXTRFNo.I6011__CTRForiginator:ULGENERALINFORMATIONCopyofmarkingplatePage3of15ReportNo.XXXXTRFNo.I6011__CTRForiginator:ULTestitemparticulars(seealsoclause5):Classificationofinstallationanduse..........................................:TransportableandportableSupplyconnection......................................................................:Non-detachablecordAccessoriesanddetachablespartsincludedintheevaluation...:---Optionsincluded........................................................................:---Possibletestcaseverdicts:-testcasedoesnotapplytothetestobject........................:N/A-testobjectdoesmeettherequirement..................................:Yes-testobjectdoesnotmeettherequirement............................:NoAbbreviationsusedinthereport:-normalcondition..............................................................:N.C.-singlefaultcondition....................:S.F.C.-operationalinsulation.......................................................:OP-basicinsulation.............................:BI-basicinsulationbetweenpartsofoppositepolarity.........:BOP-supplementaryinsulation..............:SI-doubleinsulation..............................................................:DI-reinforcedinsulation.....................:RIGeneralremarks:ThisreportisnotvalidasaCBTestReportunlessappendedtoaCBTestCertificateissuedbyaNCB,inaccordancewithIECEE02.(seeAttachment#)referstoadditionalinformationappendedtothereport.(seeappendedtable)referstoatableappendedtothereport.Throughoutthisreportapointisusedasthedecimalseparator.Thetestsresultspresentedinthisreportrelateonlytotheobjecttested.Thisreportshallnotbereproducedexceptinfullwithoutthewrittenapprovalofthetestinglaboratory.Listoftestequipmentmustbekeptonfileandavailableforreview.Summaryofcontentsprovidedonthelastpageofthisreport.Generalproductinformationandconsiderations:TheA&J-POCB01OxygenConcentratorisintendedforuseasanoxygenconcentratortoprovidesupplementallowflowoxygentherapyinthehome,nursinghomes,patientcarefacilities,etc.TheA&J-POCB01isavailablebyprescriptiononlyunderthesupervisionofaphysician,andisnotintendedtosupportorsustainlife.Page4of15ReportNo.××××TRFNo.I6011__CTRForiginator:ULSECTIONREQUIREMENTComment/ObservationCompliance(YES/NO/N/A)6.Identification,markinganddocuments//6.8Accompanyingdocuments//6.8.201AllrelevantinformationregardingsignificantRESIDUALRiskincludingdescriptionsoftheHAZARDSandanyactionsbytheOPERATORortheUSERnecessarytoavoid/mitigatethemshallbeplacedinboththeINSTRUCTIONSFORUSEandtheRISKMANAGEMENTFILE.“UseManual”and“RiskManagementReport”includealltherelevantinformationregardingsignificantRESIDUALRiskincludingdescriptionsoftheHAZARDSandanyactionsbytheOPERATORortheUSERnecessarytoavoid/mitigatethem.YES6.8.202ACCOMPANYINGDOCUMENTSforthePEMSshallidentify,asaminimum,theMANUFACTURERandauniqueidentifiersuchasrevisionlevelanddateofrelease/issue.“UseManual””identifiestheMANUFACTURERandauniqueidentifiersuchasrevisionlevelanddateofrelease/issue.YES52Abnormaloperationandfaultconditions//52.201Documentation//52.201.1DocumentsproducedfromapplicationofthisstandardshallbemaintainedandTheprocedureforDeviceriskanalysisshallformpartofthequalityrecords;seefigure201.Thisshouldbedoneinaccordancewith6.3ofISO9000-3.Documentsproducedfromapplicationofthisstandardmaintainedaccordingto“DocumentManagementRequirementsofR&DDepartment”andtheprocedureforDeviceriskanalysishasformedapartofthequalityrecordsinthe“RiskManagementReport”accordingto6.3ofISO9000-3YES52.201.2Thesedocuments,hereinreferredtoastheRISKMANAGEMENTFILE,shallbeapproved,issuedan