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60601ClauseChecklist,Rev.34(03/2007)MedicalEvaluationPackage(IEC60601-1withNationalDeviations)MECA-MedicalEquipmentComplianceAssociates,LLC(Downloadat)CompiledbyBrianR.Biersach1IEC60601-1WithNationalDeviations(UL60601-1,CSAC22.2No.601.1,EN60601-1)Company:Contact:ProductType:Phone:Model(s):Email:Ratings(V,Hz,A/W/VA,Bat.):INSULATIONDIAGRAMTable:toinsulationdiagramAreaInsulationBOP,BI,SI,DI/RIReferencevoltage(V)Requiredcreepage(mm)Requiredclearance(mm)Measuredcreepage(mm)Measuredclearance(mm)DielectricVoltage(kV)RemarksABCDEFGHIJKLMNOP60601ClauseChecklist,Rev.34(03/2007)MedicalEvaluationPackage(IEC60601-1withNationalDeviations)MECA-MedicalEquipmentComplianceAssociates,LLC(Downloadat)CompiledbyBrianR.Biersach2EVALUATIONPROCEDURE:Overallequipmentdescription,accessoriestoequipment,area(s)equipmentwillbeused,intendedpowersupply,overallobjectives¡¡MECAProjectProposal(Quote)¡PO#fromClienttoopenproject¡Anticipateddatesampleswillbereadyfortesting¡Anticipatedequipmentproductiondate¡ULL-37&L-40formssigned¡PreliminaryEvaluation:¡Examineequipment,discussitsuse,accessories,interconnectiontootherequipment,constructionmaterials¡Determineifcollateralorparticularstandardsarerequired(SeelistofCollateral&ParticularStandards)¡DocumentClassificationofequipment(PerClause5)¡Examineenclosureopenings(toolrequiredtoaccessliveparts)andpotentialmechanicalhazards,pinchpoints¡Determinepotentialhazardsundernormaluse,abnormaluse,SingleFaultConditions¡CreateInsulationDiagramAllcomponentsthatcrossabarrier(perinsulationdiagram)mustmeetcreepage&clearancerequirements-Theworkingvoltageofabarrierisdeterminedbymeasurement-Ifeither/bothsidesofbarrierarefloating,thehighestvoltagesoneithersideofbarrieraresummed(exceptwhereoneside≤25V)¡Verifypowersupplycertification,constructionandrequiredfusingforequipment¡Verifyrequiredspacings,pertheInsulationDiagram¡Determinecomponentrequirements(ULRecognition,Electrical,Mechanical,FlameRatings,etc.)¡Createtestplan(SeeTestingChecklist)¡Reviewrequirementsforlabels,usermanual(PerClause6)¡Addressanyinitialnoncompliances¡OpenULProject(ULFile#,ULProject#,ULControl#)¡SamplesreadyfortestingEquipmentEvaluation,Testing,Documentation¡VerifycorrectednoncompliancesfromPreliminaryEvaluation(asapplicable)¡Conductfullconstructionevaluationtostandardrequirements,reviewspecificationsandcertificatesforcriticalcomponents¡ConductInitialReviewwithUnderwritersLaboratories(Construction,documentationandtestplan)¡PerformrequiredtestingatMECA’sULwitnesstestingfacility(orUL,whenrequired)¡Verifylabelmarkingrequirements¡Verifyaccompanyingdocumentrequirements¡ReviewBiocompatibilityonpatientcontactparts,asapplicable(supplier’sbiocompatibilityinformationacceptable)[ISO10993-1]¡Softwareevaluation[IEC60601-1-4+ISO/IEC12207+ANSI/UL1998,2ndEdition].-Requiredifmitigatingfire,shock,ormechanicalhazardsinN.C.andS.F.C;orifrequiredbyapplicableparticularstandard(s)¡Takephotographsofequipmentforreport(1200x1600pixelsminimum)¡Createcriticalcomponentlist,includingallcomponentsneededtopasstestsandmeettherequirementsofthestandard¡WriteULInformativeTestReport(CB-Style)forUL/C-UL(forUSandCanada)Classification¡FinalreviewwithUnderwritersLaboratories¡ULIssueAuthorizationtoapplytheULMarkandprovidesULReportqEMCtesting(OptionalinUSforULMark,requiredforEuropebytheMDD)[IEC60601-1-2]qCBReport(Optional-RequiredonlyforobtainingotherSafetyMarks–VDE,TUV,NEMKO,SEMKO,etc.)(NotrequiredforCEMarking)qOptionalCEMarkingservicesforsaleintheEuropeanUnion-AssistwithyourcompliancedocumentationfortheMedicalDeviceDirective(MDD),set-upand/orworkwithyourNotifiedBody,asnecessaryByBrianR.Biersach60601ClauseChecklist,Rev.34(03/2007)MedicalEvaluationPackage(IEC60601-1withNationalDeviations)MECA-MedicalEquipmentComplianceAssociates,LLC(Downloadat)CompiledbyBrianR.Biersach3#ResolvedIssues,Noncompliances60601ClauseChecklist,Rev.34(03/2007)MedicalEvaluationPackage(IEC60601-1withNationalDeviations)MECA-MedicalEquipmentComplianceAssociates,LLC(Downloadat)CompiledbyBrianR.Biersach4IEC60601-1/UL2601-1TESTCHECKLISTAllTestsConductedat90–110%VoltageRatings,ExceptPowerInputTest(ConductedatRatedVoltage)Test#CLAUSETESTT0CONSTRUCTIONEVALUATIONRequiredSpacingsperInsulationDiagram,ConstructionRequirements,CriticalComponents[Caliper,Probes]T16.1MARKINGDURABILITYRubcottonrag15secondsonLabels/markingswitheach[DistilledWater,DenaturedAlcohol(Methylatedspirits),Isopropylalcohol]T27.1POWERINPUTAtratedvoltage,stabilizedW,V,orVArecorded[PowerAnalyzer-Volts,Amps,Watts]T315.bVOLTAGELIMITATION(PART1)If0.1μFinmains:Voltagemeasuredbetweensupplypins,enclosure,andearth[Oscilloscope,or1sec.Switchbox+VoltMeterwithmax.]T415.cVOLTAGELIMITATION(PART2)Residualvoltagemeasuredoncapacitors/circuitsafteropeningenclosureif0.27μF(120V)or0.07μF(240V)[Oscilloscope]T517.h1,17.h2DEFIBRILLATION-PROOFAPPLIEDPARTSDEFIBRILLATION-PROOFRECOVERYTIMEMeasurementstakenperFig.50or51(AppliedtoAccessibleParts)[Oscilloscope]T61