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1、AmericanNationalANSI/AAMIEC11:1991/(R)2001StandardDiagnosticelectrocardiographicdevicesAssociationfortheAAMIAdvancementofMedicalInstrumentationAssociationfortheAdvancementofMedicalInstrumentation1110N.GlebeRd.,Suite220Arlington,VA22201-4795©2000bytheAssociationfortheAdv
2、ancementofMedicalInstrumentationAllRightsReservedCopyrightandPermissionsPublication,reproduction,photocopying,storage,ortransmission,electronicallyorotherwise,ofalloranypartofthesedocumentswithoutthepriorwrittenpermissionoftheAssociationfortheAdvancementofMedicalInstrum
3、entationorthecopyrightholder(ifnotAAMI)isprohibitedbylaw.Itisillegalunderfederallaw(17U.S.C.§101,etseq.)tomakecopiesofalloranypartofthesedocuments(whetherinternallyorexternally)withoutthepriorwrittenpermissionofthecopyrightholder.Violatorsrisklegalaction,includingcivila
4、ndcriminalpenalties,anddamagesof$100,000peroffense.Forpermissionregardingtheuseofalloranypartofthesedocuments,contactAAMI,1110N.GlebeRoad,Suite220,Arlington,VA22201-4795.Phone:(703)525-4890;Fax:(703)525-1067.ViolatorsofthiscopyrightpolicyshouldbereportedtoAAMI’slegalcou
5、nsel:McKenna&Cuneo,L.L.P.1900KStreet,N.W.Washington,DC20006Attn:JacquelineA.Henson,Esq.Phone:(202)496-7500EC11DiagnosticelectrocardiographicdevicesDiagnosticelectrocardiographicdevicesANSI/AAMIEC11:1991/(R)2001(RevisionofANSI/AAMIEC11:1982andANSI/AAMIEC11a:1984)American
6、NationalStandardDiagnosticelectrocardiographicdevicesDevelopedbyAssociationfortheAdvancementofMedicalInstrumentationApproved24October1991andreaffirmed4May2001byAmericanNationalStandardsInstituteAbstract:Thisstandardestablishesminimumsafetyandperformancerequirementsforel
7、ectrocardiographic(ECG)systemswithdirectwritingdeviceswhichareintendedforuseinECGcontouranalysisfordiagnosticpurposes.CommitteerepresentationAssociationfortheAdvancementofMedicalInstrumentationThisstandardwasdevelopedbytheDiagnosticElectrocardiographSubcommitteeunderthe
8、auspicesoftheElectrocardiographCommittee.Committeeapprovalofthestandarddoesnotnecessarilyimplythatallcommittee
