AAMI TIR12-2020(R2023) Designing, testing, and__labeling medical devices intended for processing by health care facilities A guide for device manufacturers 医疗设备的设计、测试和标签.pdf

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AAMITechnicalInf，。rmationReportAAMITIR12:2020/(R)2023

Designing,testing,andlabelingmedicaldevices

intendedforprocessingbyhealthcarefacilities:A

guidefordevicemanufacturers

Approved17September2020andreaffirmed7September2023by

AAMI

Abstract:Thistechnicalinformationreport(TIR)providesguidancetomedicaldevicemanufacturers,whoare

requiredtoprovideinstructi。nsthatdetailtheprocessingstepsfr，。mpre-treatmentatthe。f

usethroughtheterminalprocessandstoragetopanyreusableandsingle-usemedical

devicesthatareprocessedbyahealthcarefacilitypri。rt。clir、icaluse.

Keywords:cleaning,decontamination,disinfection,instructionsforuse,medicaldevicedesign,steriliZation

AAMITechnicalInformationReport

Atechnicalinformationrepo叫σJR)isapublicationoftheAss。ciationfortheAdvan佣mentofMedicallnstrumen阳tion

(AAMJ)StandardsB。ardthataddressesaparticularaspect。fmedicaltechn。l。gy.

Although由ematerialpresentedinaTIRmayneedfurtherevaluati。nbyexperts,releasingtheinformationisvaluable

becausetheindustryandtheprofessionshaveanimmediateneedforit.

ATIRdiffersmarkedlyfromastandardorrecommendedpractice,andreaderssh。uldunderstandthedifferen。es

betweenthesedocuments.

Standardsandrecommendedpracticesaresubjecttoaformalprocessofc。mmitteeapproval,publicreview,and

resolution。fallcomments.ThisprocessofconsensusissupervisedbytheAAMIStandardsBoardand,inthecase。f

AmericanNationalStandards,bytheAmericanNationalStandardsInstitute.

ATIRisnotsubjecttothesameformalapprovalprocessasastandard.However,aTIRisapprovedfordistributionby

atechni臼Icomm

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