青海2025自考[医疗器械与装备]英语二模拟题及答案.docxVIP

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青海2025自考[医疗器械与装备工程]英语（二）模拟题及答案

一、单项选择题（共20题，每题1分，计20分）

1.Inthefieldofmedicaldevicemanufacturing,whichofthefollowingmaterialsiscommonlyusedforbiocompatibleimplantsduetoitsexcellentcorrosionresistanceandmechanicalstrength?

A.Stainlesssteel

B.Titaniumalloy

C.Plasticpolymer

D.Ceramiccomposite

2.Theprocessofensuringthatmedicaldevicesmeetsafetyandperformancestandardsisknownas:

A.Qualityassurance

B.Regulatorycompliance

C.Productvalidation

D.Alloftheabove

3.WhatdoestheISO13485standardprimarilyfocusonin医疗器械与装备工程?

A.Environmentalsustainability

B.Qualitymanagementsystems

C.Clinicaltrialprotocols

D.Devicecalibrationprocedures

4.WhichofthefollowingisakeyconsiderationwhendesigningamedicaldeviceforuseintheQinghairegion,wheretemperaturescandropbelow-20°C?

A.Waterproofing

B.Thermalinsulation

C.UVresistance

D.Electromagneticcompatibility

5.Inthecontextofmedicalimagingequipment,whatdoesthetermresolutionreferto?

A.Theabilitytoproducehigh-contrastimages

B.Theclarityoftheimagedetail

C.Thespeedofimageacquisition

D.TheintensityofX-raypenetration

6.WhichtypeofmedicaldeviceisclassifiedasaClassIIImedicaldeviceintheFDAsregulatoryframework?

A.Bandages

B.Surgicalmasks

C.Pacemakers

D.Elasticbands

7.Thetermsterilizationinmedicaldevicemanufacturingrefersto:

A.Cleaningthedevicewithalcohol

B.Killingallmicroorganismsonthedevice

C.Applyingalubricanttothedevice

D.Checkingthedevicefordefects

8.Whatistheprimarypurposeofariskmanagementfilein医疗器械与装备工程?

A.Todocumentmarketingstrategies

B.Toassessandmitigatepotentialhazards

C.Totrackinventorylevels

D.Topreparefinancialreports

9.Whichofthefollowingisacommonmethodforensuringthereliabilityofmedicalelectronicdevices?

A.Regularlyreplacingbatteries

B.Conductingstresstesting

C.Applyingdecora