湖南2025自考[醫(yī)療器械與裝備工程]英語（二）高頻題(考點)一、單項選擇（共10題，每題1分）1.Inthefieldofmedicaldevicemanufacturing,ultrasonicweldingiswidelyusedduetoitsabilitytojoinheat-sensitivematerialswithoutcausingdamagetothestructuralintegrityofthecomponents.A.advantageouslyB.adverselyC.predominantlyD.efficiently2.TheFoodandDrugAdministration(FDA)requiresmanufacturerstosubmitpremarketapproval(PMA)applicationsforhigh-riskmedicaldevicesbeforetheycanbecommerciallymarketedintheUnitedStates.A.preliminaryB.postmarketC.conditionalD.regulatory3.3Dprintingtechnologyhasrevolutionizedtheproductionofcustomizedprostheticlimbs,allowingforpatient-specificdesignswithhighprecision.A.standardizedB.modularC.personalizedD.industrial4.Whendesigningmedicalimagingequipment,engineersmustensurethattheradiationdoseremainswithinsafelimitstominimizepatientexposure.A.minimalB.permissibleC.excessiveD.operational5.TheISO13485standardoutlinesqualitymanagementrequirementsforthedesign,production,anddistributionofmedicaldevices,emphasizingtraceabilityandriskmitigation.A.operationalB.complianceC.theoreticalD.procedural6.Artificialintelligence(AI)isincreasinglyappliedinmedicaldiagnosticsystemstoenhanceaccuracyandreducehumanerrorininterpretingtestresults.A.redundancyB.variabilityC.reliabilityD.complexity7.Biocompatibilitytestingisacriticalstepinensuringthatmedicalimplantsdonotcausenegativeimmuneresponsesortissuerejectioninpatients.A.allergicB.systemicC.localizedD.reversible8.TheEuropeanUnion'sMedicalDeviceRegulation(MDR)mandatesthatmanufacturersconductpostmarketsurveillance(PMS)tomonitorthesafetyandperformanceofdevicesaftertheyarereleased.A.periodicB.preliminaryC.optionalD.voluntary9.Robot-assistedsurgerysystemsimproveoperationalprecisionbyenablingsurgeonstoperformminimallyinvasiveprocedureswithenhanceddexterity.A.manualB.automatedC.traditionalD.experimental10.Regulatorydocumentationmustincludetechnicalspecifications,clinicaldata,andmanufacturingprocedurestoensurecompliancewithglobalstandards.A.exhaustiveB.summarizedC.verifiedD.confidential二、完形填空（共1題，每題2分，共20分）Readthepassagebelowandchoosethebestwordforeachblank.TheEvolutionofMedicalDeviceManufacturingThemanufacturingofmedicaldeviceshasundergonesignificantadvancementsoverthepastfewdecades,drivenbytechnologicalinnovationsandregulatoryreforms.Initially,mostdeviceswerehandcraftedusingbasictools,buttheadventofautomationrevolutionizedtheindustrybyimprovingefficiencyandconsistency.Today,high-precisionmachineryandcomputer-aideddesign(CAD)areessentialinproducingdevicessuchaspacemakers,respirators,anddialysismachines.Moreover,theintegrationofsmarttechnologieshasenabledthedevelopmentofconnectedmedicaldevicesthatcanmonitorpatienthealthinrealtime.Forexample,wearablesensorsandremotemonitoringsystemshavetransformedthewaychronicdiseasesaremanaged.However,theseinnovationsalsoraiseethicalandprivacyconcerns,necessitatingstringentdataprotectionmeasures.Toensuredevicesafety,manufacturersmustadheretointernationalstandardssuchasISO13485andFDAguidelines.Regulatorycomplianceinvolvesrigoroustesting,qualitycontrol,andtraceabilitythroughouttheproductlifecycle.Asthehealthcareindustrycontinuestoevolve,themanufacturingofmedicaldeviceswillfurtherembracedigitalization,artificialintelligence,andsustainablepracticestomeetthegrowingdemandforpatient-centricsolutions.1.A.processB.productionC.developmentD.design2.A.transformativeB.traditionalC.limitedD.inefficient3.A.utilizedB.manufacturedC.engineeredD.assembled4.A.facilitatesB.hindersC.requiresD.neglects5.A.advancementsB.limitationsC.challengesD.failures6.A.wearableB.invasiveC.improvisedD.passive7.A.addressesB.ignoresC.challengesD.overlooks8.A.measuresB.proceduresC.standardsD.principles9.A.regulatoryB.technicalC.ethicalD.commercial10.A.accelerateB.delayC.prioritizeD.optimize三、閱讀理解（共5題，每題2分，共10分）Readthepassagebelowandanswerthequestions.TheRoleofIoTinMedicalDeviceManagementTheInternetofThings(IoT)hasemergedasagame-changerinthemedicaldeviceindustry,enablingreal-timedatacollection,remotediagnostics,andsmartmonitoring.Connecteddevices,suchasimplantablepacemakersandhomebloodpressuremonitors,cantransmitcriticalhealthmetricstohealthcareproviders,improvingdiagnosticaccuracyandpatientoutcomes.Additionally,IoTsolutionsenhancesupplychainefficiencybytrackingmedicalequipment,managinginventory,andalertingstakeholdersaboutmaintenanceneeds.However,theimplementationofIoTinhealthcarefacessignificantchallenges,includingcybersecurityrisks,dataprivacyconcerns,andinteroperabilityissues.RegulatorybodiessuchastheFDAandtheEuropeanMedicinesAgency(EMA)haveissuedguidelinestoensurethatIoT-enableddevicesmeetsafetyandsecuritystandards.Manufacturersmustprioritizeencryption,securecommunicationprotocols,andpatientconsentmechanismstoaddresstheseregulatoryrequirements.Despitetheseobstacles,thepotentialbenefitsofIoTinmedicaldevicemanagementaretremendous.Byleveragingsmarttechnologies,healthcaresystemscanreducecosts,improveoperationalefficiency,anddelivermorepersonalizedcare.Asdigitaltransformationcontinues,IoTwillplayanincreasinglypivotalroleinshapingthefutureofhealthcaredelivery.1.WhatistheprimarypurposeofIoTinmedicaldevicemanagement?A.ToenhancemanufacturingprocessesB.ToimprovepatientmonitoringanddatacollectionC.TostreamlinesupplychainoperationsD.Toincreasedevicesales2.Accordingtothepassage,whatarethreekeychallengesassociatedwithIoTinhealthcare?A.Costinefficiency,technicalcomplexity,andlimitedscalabilityB.Cybersecurityrisks,dataprivacyconcerns,andinteroperabilityissuesC.Regulatorydelays,manufacturingflaws,andpatientresistanceD.Powersupplyfailures,signaldisruptions,andusererrors3.HowdoregulatorybodiesaddressIoT-enabledmedicaldevices?A.ByprohibitingtheiruseinhealthcaresettingsB.ByencouragingrapidadoptionwithoutoversightC.ByissuingguidelinesforsafetyandsecuritycomplianceD.Bytransferringresponsibilitytomanufacturers4.WhatbenefitsdoesIoTbringtohealthcaresystems?A.Reducedcosts,improvedefficiency,andenhancedpatientcareB.Increasedcompetition,shorterdevelopmentcycles,andwidermarketreachC.Higherdeviceprices,longerapprovaltimes,andfewerinnovationsD.Manualdataprocessing,limitedscalability,andtraditionalmethods5.Whatistheauthor'sperspectiveonthefutureofIoTinhealthcare?A.ItisineffectiveandshouldbeabandonedB.IthaslimitedpotentialandwillremainunderutilizedC.ItisapivotaltechnologythatwilltransformhealthcaredeliveryD.Itisashort-termtrendthatwillloserelevanceovertime四、翻譯（共2題，每題5分，共10分）TranslatethefollowingsentencesintoChinese.1.Theintegrationofartificialintelligenceintomedicalimagingsystemshassignificantlyimproveddiagnosticaccuracybyanalyzingcomplexdatasetsandidentifyingsubtleanomalies.2.Regulatorycomplianceinthemedicaldeviceindustryrequiresmanufacturerstosubmitextensivedocumentation,includingtechnicalmanuals,clinicaltrials,andpostmarketsurveillancereports,todemonstratethattheirproductsmeetglobalstandards.五、簡答題（共2題，每題10分，共20分）1.ExplainthesignificanceoftheISO13485standardinmedicaldevicemanufacturing.2.Howdoes3Dprintingtechnologycontributetothecustomizationofmedicaldevices?Providetwospecificexamples.答案與解析一、單項選擇1.A.advantageously-解析：超聲波焊接在醫(yī)療器械制造中具有“有利”地連接熱敏材料的能力，不會損壞組件的結(jié)構(gòu)完整性。2.A.preliminary-解析：FDA要求制造商在將高風(fēng)險醫(yī)療器械商業(yè)化之前提交“初步”的PMA申請。3.C.personalized-解析：3D打印技術(shù)通過允許個性化設(shè)計，徹底改變了定制假肢的生產(chǎn)。4.B.permissible-解析：設(shè)計醫(yī)療成像設(shè)備時，必須確保輻射劑量保持在“允許”的安全范圍內(nèi)，以最大限度地減少患者暴露。5.B.compliance-解析：ISO13485標準概述了醫(yī)療器械設(shè)計、生產(chǎn)和分銷的“質(zhì)量管理要求”，強調(diào)可追溯性和風(fēng)險mitigation。6.C.reliability-解析：AI在醫(yī)療診斷系統(tǒng)中的應(yīng)用提高了“可靠性”，減少了人為錯誤。7.B.systemic-解析：生物相容性測試是確保醫(yī)療植入物不會引起全身性免疫反應(yīng)或組織排斥的關(guān)鍵步驟。8.A.periodic-解析：歐盟的MDR要求制造商進行“定期”的PMS，以監(jiān)控設(shè)備發(fā)布后的安全性和性能。9.B.automated-解析：機器人輔助手術(shù)系統(tǒng)通過使外科醫(yī)生能夠進行微創(chuàng)手術(shù)，提高了操作精度，體現(xiàn)了自動化優(yōu)勢。10.C.verified-解析：監(jiān)管文件必須包括技術(shù)規(guī)格、臨床數(shù)據(jù)和制造程序，以確保符合全球標準。二、完形填空1.B.production-解析：本文討論的是“醫(yī)療設(shè)備的生產(chǎn)”過程。2.A.transformative-解析：自動化徹底改變了制造業(yè)。3.A.utilized-解析：自動化被“利用”來提高效率。4.A.facilitates-解析：自動化促進了高精度機械的使用。5.A.advancements-解析：制造業(yè)經(jīng)歷了技術(shù)進步。6.A.wearable-解析