北京2025自考[醫(yī)療器械與裝備工程]英語(yǔ)（二）選擇題專練一、單選題（共10題，每題2分）1.Medicaldevicesareclassifiedintodifferentriskcategoriesbasedontheirpotentialtocauseharm.WhichofthefollowingstatementsbestdescribestheClassIIImedicaldevice?A.Deviceswithminimalriskofinjuryorillness.B.Devicesthatarenon-invasiveandhavealowriskofmalfunction.C.Devicesthatmaysupportorsustainlifeandhavethehighestriskoffailure.D.Devicesthatareintendedfordiagnosticortherapeuticpurposesbutcarrymoderaterisk.2.IntheISO13485qualitymanagementsystem,whichdocumentoutlinesthecompany’sprocessformanagingproductrisksandhazards?A.RiskManagementPlanB.QualityManualC.ControlPlanD.CorrectiveActionRequest3.Abiocompatiblematerialusedinorthopedicimplantsmustmeetwhichofthefollowingcriteriatoensurelong-termimplantationsafety?A.Highelectricalconductivitytoaidinosseointegration.B.Compatibilitywithhumantissues,minimaltoxicity,andnoimmuneresponse.C.Highthermalexpansiontomatchbonedensity.D.Abilitytobesterilizedwithoutdegradingitsmechanicalproperties.4.TheFDA’s510(k)submissionisrequiredformedicaldevicesthat:A.Areintendedfordiagnosticuseonly.B.ArealreadyclearedformarketingintheU.S.andrequiremodifications.C.Areclassifiedaslow-riskdevicesrequiringnopremarketreview.D.AremanufacturedoutsidetheU.S.forimport.5.Whichmedicalimagingmodalityusesmagneticfieldsandradiowavestogeneratedetailedimagesofinternalbodystructureswithoutionizingradiation?A.ComputedTomography(CT)B.MagneticResonanceImaging(MRI)C.PositronEmissionTomography(PET)D.Ultrasound6.Inmedicaldevicedesign,the"user-centereddesign"approachemphasizes:A.Minimizingmanufacturingcostsregardlessofusability.B.Prioritizingtechnicalspecificationsoveruserneeds.C.Ensuringthedeviceiseasytooperateandunderstandforitsintendedusers.D.Reducingregulatorycompliancerequirements.7.Asterilizationmethodusingsteamunderpressuretokillmicroorganismsiscalled:A.EthyleneOxideGasSterilizationB.AutoclavingC.RadiationSterilizationD.UVSterilization8.Whichinternationalstandardspecifiesrequirementsforthesafetyandperformanceofmedicalelectricalequipment?A.IEC60601B.ISO10993C.IEC62304D.ISO134859.The"GoodManufacturingPractices(GMP)"inthemedicaldeviceindustryprimarilyfocuson:A.Marketingandadvertisingofmedicalproducts.B.Ensuringproductqualityandconsistencythroughstandardizedprocesses.C.Reducingproductcoststomaximizeprofits.D.Postmarketsurveillanceandregulatoryreporting.10.Amedicaldevicethatrequiresreprocessingbetweenusesmustbedesignedtoallowforsafeandeffectivecleaningandsterilization.Whichfactoriscriticalinthisdesign?A.Lightweightmaterialstoreducehandlingeffort.B.Smoothsurfaceswithnocrevicestopreventmicrobialbuildup.C.Highaestheticappealforpatientcomfort.D.Complexmechanicalcomponentsfordurability.二、多選題（共5題，每題2分）1.Whichofthefollowingregulatoryagenciesoverseemedicaldeviceapprovalindifferentregions?A.U.S.FoodandDrugAdministration(FDA)B.EuropeanMedicinesAgency(EMA)C.ChinaNationalMedicalProductsAdministration(NMPA)D.MinistryofHealth,LabourandWelfare(MHLW)ofJapanE.WorldHealthOrganization(WHO)2.Keyrequirementsforamedicaldevice’sriskmanagementplaninclude:A.Identificationofhazardsandpotentialharm.B.Assessmentofriskseverityandlikelihood.C.Implementationofcontrolmeasurestomitigaterisks.D.Documentationofriskanalysisactivities.E.Regularreviewandupdateoftheplan.3.Biocompatibilitytestingformedicalimplantsinvolvesevaluating:A.Hemocompatibility(bloodcompatibility).B.Cytotoxicity(cellulartoxicity).C.Sensitizationpotential(allergicreactions).D.Irritationpotential(tissuereaction).E.Mechanicalstrengthunderphysiologicalloads.4.AdvantagesofusingMagneticResonanceImaging(MRI)inmedicaldiagnosticsinclude:A.Noexposuretoionizingradiation.B.Highspatialresolutionfordetailedimaging.C.Abilitytovisualizesofttissueseffectively.D.Compatibilitywithmostcontrastagents.E.Shortexaminationtimesforpatients.5.Criticalconsiderationsinmedicaldevicepackaginginclude:A.Protectionagainstphysicaldamageduringtransport.B.Barrierpropertiestopreventcontamination.C.Compliancewithregulatoryrequirementsforsterilization.D.Child-resistantfeaturesforsafety.E.Cost-effectivenesswithoutcompromisingsafety.三、判斷題（共10題，每題1分）1.TrueorFalse?AClassImedicaldevicehasthehighestriskofcausingharmcomparedtoClassIIandClassIIIdevices.2.TrueorFalse?TheISO10993seriesofstandardscoversthebiocompatibilityofmedicalmaterials.3.TrueorFalse?A510(k)submissionisrequiredfornewmedicaldevicesenteringtheU.S.market.4.TrueorFalse?Ultrasoundimagingusessoundwavestocreateimages,anditissaferthanMRIforpatientswithmetalimplants.5.TrueorFalse?GoodManufacturingPractices(GMP)primarilyfocusondocumentationratherthanactualproductionprocesses.6.TrueorFalse?Autoclavingisthemosteffectivemethodforsterilizingmedicaldevicesthatareheat-sensitive.7.TrueorFalse?User-centereddesign(UCD)ensuresthatamedicaldevicemeetstheneedsofhealthcareprofessionalsratherthanpatients.8.TrueorFalse?Medicaldevicesrequiringreprocessingmustbedesignedwithfeaturesthatpreventmicrobialcontaminationaftercleaning.9.TrueorFalse?TheFDA’sQualitySystemRegulation(QSR)isequivalenttoISO13485intermsofrequirements.10.TrueorFalse?Amedicaldevice’sriskmanagementplanshouldbeupdatedonlyifsignificantchangesaremadetothedevice.答案與解析一、單選題1.C-解析：ClassIIImedicaldevicesareintendedtosupportorsustainlifeandhavethehighestriskoffailure,requiringstrictregulatoryoversight.2.A-解析：TheRiskManagementPlanisakeydocumentinISO13485,detailinghowthecompanyidentifies,analyzes,andcontrolsproductrisks.3.B-解析：Biocompatibilityensuresthematerialissafeforlong-termimplantation,withminimaltoxicityandnoadverseimmuneresponses.4.B-解析：The510(k)submissionisfordevicesthataresubstantiallyequivalenttoalreadyclearedproducts.5.B-解析：MRIusesmagneticfieldsandradiowaves,unlikeCT(X-rays),PET(ionizingradiation),orultrasound(soundwaves).6.C-解析：User-centereddesignprioritizesusabilityandeaseofoperationfortheintendedusers.7.B-解析：Autoclavingusessteamunderpressureforsterilization,acommonmethodinhealthcare.8.A-解析：IEC60601isthestandardformedicalelectricalequipmentsafety.9.B-解析：GMPensuresproductqualitythroughstandardizedmanufacturingprocesses.10.B-解析：Smooth,crevice-freesurfacespreventmicrobialbuildupinreprocesseddevices.二、多選題1.A,B,C,D-解析：FDA(U.S.),EMA(Europe),NMPA(China),andMHLW(Japan)aremajorregulatoryagenciesformedicaldevices.WHOisaglobalhealthorganization,notaregulatorybody.2.A,B,C,D,E-解析：Riskmanagementrequireshazardidentification,riskassessment,controls,documentation,andperiodicreviews.3.A,B,C,D-解析：Biocompatibilitytestingincludeshemocompatibility,cytotoxicity,sensitization,andirritation.Mechanicalstrengthisnotpartofbiocompatibilitytesting.4.A,B,C,D-解析：MRIhasnoionizingradiation,highresolution,effectivesofttissueimaging,andcompatibilitywithcontrastagents.Shortexaminationtimesarenotaprimaryadvantage.5.A,B,C,E-解析：Packagingmustprotectdevices,preventcontamination,meetsterilizationrequirements,andbecost-effective.Child-resistantfeaturesarenotalwaysnecessary.三、判斷題1.Fal