湖北2025自考[医疗器械与装备]英语二模拟题及答案.docxVIP

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湖北2025自考[医疗器械与装备工程]英语（二）模拟题及答案

一、选择题（共20题，每题1分，计20分）

1.Inthefieldofmedicaldevicemanufacturing,whichofthefollowingmaterialsiscommonlyusedforsurgicalinstrumentsduetoitshighcorrosionresistanceanddurability?

A.Stainlesssteel

B.Aluminumalloy

C.Titaniumalloy

D.Plasticpolymer

2.Theprocessofensuringthatmedicaldevicesmeetsafetyandperformancestandardsisknownas______.

A.Qualityassurance

B.Devicevalidation

C.Regulatorycompliance

D.Riskmanagement

3.Whichinternationalstandardisprimarilyfocusedonthequalitymanagementsystemsformedicaldevicemanufacturers?

A.ISO13485

B.IEC60601

C.FDA21CFR

D.ISO9001

4.Inmedicalimagingequipment,thetermcontrastagentreferstoasubstancethat______.

A.Enhancesimageclarity

B.Reducesradiationexposure

C.Improvesdeviceefficiency

D.Increasesscanningspeed

5.TheFoodandDrugAdministration(FDA)isaregulatoryagencyinwhichcountry?

A.Japan

B.China

C.Germany

D.UnitedStates

6.WhichtypeofmedicaldeviceisclassifiedasaClassIIIdeviceundertheFDAregulations?

A.Bandages

B.Hearingaids

C.Pacemakers

D.Surgicalblades

7.Theprinciplebehindultrasoundimagingisbasedontheuseof______.

A.X-rays

B.Magneticfields

C.Soundwaves

D.Electricalcurrents

8.Inthecontextofmedicaldevicedesign,ergonomicsreferstothestudyof______.

A.Devicereliability

B.Userinteractionandcomfort

C.Manufacturingefficiency

D.Materialstrength

9.Whichofthefollowingisakeyrequirementformedicaldevicesintendedforimplantation?

A.Biocompatibility

B.Waterproofing

C.Lowpowerconsumption

D.Highthermalconductivity

10.TheEuropeanUnionMedicalDeviceRegulation(EUMDR)isapplicableto______.

A.AllmedicaldevicessoldinEurope

B.Onlyhigh-riskmedicaldevices

C.Onlydiagnosticequipment

D.Onlysurgicalinstruments

11.Aclinicaltrialisaprocessusedto______.

A.Testthesafetyofamedicaldevice