2026年医疗器械技术人员招聘考试（英语）历年参考题库含答案详解.docxVIP

2026年医疗器械技术人员招聘考试（英语）历年参考题库含答案详解

一、单项选择题

下列各题只有一个正确答案，请选出最恰当的选项（共20题）

1、WhichISOstandardspecifiesrequirementsforqualitymanagementsystemsinthemedicaldeviceindustry?

A.ISO9001

B.ISO13485

C.ISO17025

D.ISO27001

2、UndertheFDAs510(k)PremarketNotification,whichstatementiscorrect?

A.Productsmustbesignificantlyequivalenttoapredicatedevice.

B.Clinicaldataisrequiredforallapplications.

C.OnlyClassIdevicesareeligible.

D.FDAapprovalisguaranteed.

3、Whichdevicecalibrationmethodisconsideredmostreliableforprecisioninstruments?

A.Visualinspection

B.Comparisonwithareferencestandard

C.Automatedself-calibration

D.Periodicre-verification

4、Whichinfectioncontrolpracticeisrecommendedforreusablemedicaldevices?

A.Single-usepackagingonly

B.High-temperaturesterilization

C.DisinfectionwithUVlight

D.Ethicalcleaningandsterilization

5、Whatdoesbiocompatibilityrefertoinmedicaldevicetesting?

A.Devicematerialsafety

B.Clinicaltrialsuccessrate

C.Userinterfacedesign

D.Marketingapprovalspeed

6、Whichdevicecategoryrequirespremarketapproval(PMA)bytheFDA?

A.ClassIdevices

B.ClassIIdevices

C.ClassIIIdevices

D.deviceswithoutregulatoryclassification

7、Whichtermdescribesadevicedesignedforaspecificfunctionwithoutintendedchange?

A.Conventionalwisdom

B.Intendeduse

C.Unintendeduse

D.Off-labeluse

8、Whichstandardspecifiesrequirementsformedicaldevicesoftware?

A.IEC62304

B.ISO13485

C.FDA21CFRPart820

D.IEC60601-1

9、Whichmaterialiscommonlyusedforbiocompatiblehypodermicneedles?

A.Titanium

B.stainlesssteel

C.polypropylene

D.silicone

10、WhichFDAregulationmandatespostmarketsurveillanceformedicaldevices?

A.FDCAct

B.FDMA

C.21CFRPart11

D.PMDA

11、根据《医疗器械监督管理条例》，医疗器械注册证书的有效期是？

（A）5年

（B）3年

（C）2年

（D）1年

12、无菌医疗器械的灭菌工艺中，辐照灭菌属于哪种灭菌方式？

（A）湿热灭菌