AAMI TIR38-2019 Medical device safety assurance case guidance 医疗器械安全保证案例指导.pdf

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AAMITechnicalInf。rmati。nRep。此AAMITIR38:2019

Medicaldevicesafetyassurance

caseguidance

Approved25January2019by

AAMI

Abstract:Pr.。videsguidanceonh。wtocompleteanAssuranceCaseRepo付in。rdertocomplywiththenew

add『itionalFDApre-marketrequiremen隐forinfusionpumps.Includesadetailedbutstrictly

hypotheticalexample『romthemedicaldeviced。main.

Keywords:safetyclaim，『iskmanagement,infusionpumps,qualitysystems

AAMITechnicalInformationReport

Atechnicalinformationrep。叫（TIR)isaρυblicationoftheAssociationfortheAdvancementofMedicallnstrumentati。n

(AAMI)StandardsB。ardthataddressesaparticularaspectofmedical恒chnology

AIth。ughthematerialpresentedinaTlRmayneedfurtherevaluationbyexpe叫s.releasingtheinfom咱ti。nisvaluable

becausetheindustryandtheprofessi

onshaveanimmediaten回dfor~.

ATIRdiffersmarledlyfromastandard。rrecommendedpractice.andreader骂shouldunderstand伽edifferences

betweenthesedocuments

Standar甘sandrecommendedp咱cticesaresu时ectt。aformalpro曲ssorcommitteeapproval，。ublicrevi脚，and

resolutionofallcomments.ThisprocessofconsensusissupervisedbytheAAMIStandardsB。ardand,inthe臼seof

AmericanNationalStandar回s.bytheAmericanNationalStandardsInstitute.

ATIRisnotsubjecttothe回meformal邵阳。valprocessasastandard.However,aTIRisapprovedfordistributionby

atechnicalcommitteeandtheAAMIStandardsB。a币。

Anotherdifferenceisthat,althoughbothstandardsandTIRsarereviewedperiodically,astandardmustbeacted。n

reaffirmed,revised，。rwithdrawn-andtheactionfor

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