重慶2025自考[醫(yī)療器械與裝備工程]英語（二）選擇題專練一、單項選擇題（共15題，每題2分，計30分）說明：本部分題目側重醫(yī)療器械與裝備工程領域的英語應用，涉及技術術語、行業(yè)規(guī)范、醫(yī)療器械設計與管理等內(nèi)容。1.WhatistheprimarypurposeofISO13485inmedicaldevicemanufacturing?A.Toensureproductcost-effectivenessB.TostandardizepackagingdesignC.ToguaranteeproductsafetyandqualitymanagementD.Toregulatemarketingstrategies2.Whichofthefollowingisamechanicaladvantageofasurgicalinstrument?A.ItslightweightmaterialB.IncreasedleverageforprecisemovementC.EnhancedcorrosionresistanceD.Waterproofcoating3.Theterm"hysteresis"inmedicalimagingtypicallyrefersto:A.Magneticresonanceimaging(MRI)signaldelayB.UltrasoundbeamattenuationC.X-raytubeoverheatingD.CTscannernoisereduction4.Whatdoes"CEmarking"signifyforamedicaldevice?A.CompliancewithChineseregulatorystandardsB.Europeanconformitytohealth,safety,andenvironmentalrequirementsC.FDAapprovalintheUnitedStatesD.InternationalOrganizationforStandardizationcertification5.Whichcomponentisessentialforapacemakertofunctioncorrectly?A.SolarbatterypowersourceB.WirelesscommunicationmoduleC.LeadlessimplantableelectrodearrayD.Externalprogrammerinterface6.Inroboticsurgery,theterm"degreesoffreedom"(DOF)refersto:A.ThenumberofsurgicalinstrumentsarobotcanhandleB.TherangeofmotionofaroboticarmC.ThepoweroutputofasurgicallaserD.Thefrequencyofmechanicalvibrations7.Whatisakeyadvantageof3Dprintinginmedicaldeviceprototyping?A.HighproductionvolumeefficiencyB.Rapidcustomizationforpatient-specificapplicationsC.LowermaterialcostscomparedtotraditionalmanufacturingD.Reducedneedforpost-processing8.The"FDA510(k)clearance"isrequiredforamedicaldevicewhen:A.ItisintendedfordiagnosticuseonlyB.ItpresentsasignificantrisktohealthprofessionalsC.ItissubstantiallyequivalenttoapredicatedeviceD.Itrequiresclinicaltrialsbeforemarketrelease9.Whichtypeofmedicalimagingusesradioactivetracerstodetectmetabolicactivity?A.MRIB.CTC.PET(PositronEmissionTomography)D.Ultrasound10.A"biocompatible"materialinmedicaldevicesmustmeetwhichcriterion?A.HighthermalconductivityB.ResistancetochemicaldegradationbybodilyfluidsC.LowelectricalinsulationpropertiesD.Highdensityfordurability11.The"FoodandDrugAdministration(FDA)"isprimarilyresponsibleforregulating:A.PharmaceuticaldrugsintheU.S.B.MedicaldevicesandconsumerproductsC.EnvironmentalprotectionstandardsD.Agriculturalbiotechnology12.Whatisthepurposeof"sterilizationvalidation"inmedicalmanufacturing?A.TominimizeproductionwasteB.Toensuremicrobial-freedevicesmeetregulatoryrequirementsC.ToreducemanufacturingcostsD.Toimprovedeviceaesthetics13.A"microprocessor-based"medicaldevicetypicallyincludes:A.AnalogcircuitryonlyB.SoftwarefordataprocessingandcontrolC.MechanicalgearsformotiontransferD.Hydraulicfluidsystems14.Whichfactoriscriticalforelectrocardiogram(ECG)accuracy?A.High-frequencysignalamplificationB.LowimpedanceelectrodesC.VibratingneedleforbettercontactD.Wirelesstransmissioncapability15.The"medicaldevicerecall"processisinitiatedwhen:A.SalesexceedprojectedtargetsB.AdevicefailsqualitycontroltestingC.RegulatorycompliancedocumentationisincompleteD.Acompetitorlaunchesasimilarproduct二、多項選擇題（共10題，每題2分，計20分）說明：本部分題目考查對醫(yī)療器械與裝備工程領域多方面知識的綜合理解，每題有多個正確選項。1.WhichofthefollowingISOstandardsarerelevanttomedicaldevicequalitymanagement?A.ISO13485B.ISO10993(biocompatibility)C.ISO9001D.ISO62304(medicalsoftware)2.Inroboticsurgerysystems,keycomponentsinclude:A.EndoscopiccamerasB.Force-sensinginstrumentsC.Real-timefeedbacksoftwareD.Manualcontrollevers3.Medicalimagingmodalitiesthatuseionizingradiationinclude:A.X-raysB.CTscansC.MRID.PETscans4.RegulatoryrequirementsformedicaldevicesinEuropeandtheU.S.sharesimilaritiesin:A.PremarketapprovalprocessesB.QualitysystemexpectationsC.DocumentationstandardsD.Testingmethodologies5.Advantagesof3Dprintinginmedicaldevicesinclude:A.CustomizedanatomicalmodelsB.RapidprototypingforsurgicalguidesC.ReducedmaterialwasteD.Scalabilityformassproduction6.Biocompatibilitytestingformedicalimplantsmayinvolve:A.CellcultureassaysB.ImplantationstudiesinanimalmodelsC.MechanicalfatiguetestingD.Chemicalleachinganalysis7.Pacemakermalfunctioncanbecausedby:A.LeadcorrosionB.BatterydepletionC.ImproperprogrammingD.Externalelectromagneticinterference8.Medicaldevicesoftwaredevelopmentmustadhereto:A.FDA’ssoftwarevalidationguidanceB.ISO13485documentationrequirementsC.UserinterfaceaccessibilitystandardsD.Hardwareintegrationprotocols9.Sterilizationmethodsformedicaldevicesinclude:A.Autoclaving(steamsterilization)B.EthyleneoxidegasC.RadiationsterilizationD.Chemicalvapordisinfection10.Challengesinwearablemedicaldevicesinclude:A.BatterylifeoptimizationB.WirelessdatatransmissionreliabilityC.RegulatoryapprovalvariabilityacrossregionsD.Usercomfortandskincompatibility三、判斷題（共5題，每題2分，計10分）說明：本部分題目考查對醫(yī)療器械與裝備工程領域基本概念的判斷能力。1.TrueorFalse:The"FDA510(k)clearance"ismandatoryforallnewmedicaldevicesenteringtheU.S.market.2.TrueorFalse:MRImachinesuseradiowavesinsteadofionizingradiation.3.TrueorFalse:Abiocompatiblematerialmustbeinerttobodilyfluidsbutcandegradeovertimewithoutadverseeffects.4.TrueorFalse:ISO13485certificationisautomaticallygrantedifamedicaldevicemeetsFDArequirements.5.TrueorFalse:3Dprintingiscurrentlynotsuitableforproducingfunctionalmedicalimplantsduetomateriallimitations.答案與解析一、單項選擇題1.C解析：ISO13485是醫(yī)療器械質量管理體系的標準，旨在確保產(chǎn)品的安全性和質量管理符合國際要求。2.B解析：手術器械的機械優(yōu)勢指通過杠桿原理實現(xiàn)精確運動的能力，提高操作效率。3.A解析：MRI中的“遲滯效應”指信號在磁場變化時出現(xiàn)的延遲，影響圖像質量。4.B解析：CE標志代表產(chǎn)品符合歐盟健康、安全和環(huán)境要求，是醫(yī)療器械進入歐洲市場的必要認證。5.C解析：起搏器的核心部件是無源電極陣列，通過生物電信號傳輸實現(xiàn)功能。6.B解析：DOF指機器人手臂的自由度，即其運動范圍和靈活性。7.B解析：3D打印可快速制造個性化醫(yī)療模型或原型，尤其適用于手術規(guī)劃。8.C解析：510(k)申請要求新設備與已上市產(chǎn)品“實質等同”，降低審批風險。9.C解析：PET掃描利用放射性示蹤劑檢測代謝活動，屬于功能性成像技術。10.B解析：生物相容性要求材料在體內(nèi)無毒性、無排斥反應。11.B解析：FDA主要負責醫(yī)療器械和部分消費產(chǎn)品的監(jiān)管。12.B解析：滅菌驗證確保醫(yī)療器械無菌，符合衛(wèi)生標準。13.