Designation:F1628–95(Reapproved2000)StandardSpecificationforLabelingandMarkingofCuffedandUncuffedTrachealTubesandRelatedTreatmentsIntendedforUseDuringLaserSurgery1ThisstandardisissuedunderthefixeddesignationF1628;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversthelabeling,marking,warn-ings,andprecautionsforcuffedanduncuffedtrachealtubesandrelatedmaterialsintendedbythemanufacturerforuseduringlasersurgeryoftheairway.1.2RationaleforthisspecificationistoprovideastandardformatforreportingresultsobtainedfromTestMethodF1497.Safetyandperformancetests,withavailabilityofresults,aredescribedinthisspecificationtoallowamanufacturerthemaximumuseoftechnologicalalternativesindesignandmaterials.Thisspecificationaddressesthelaserresistanceoftheshaftofthetrachealtubes.Othercomponentsofthesystem,suchastheinflationsystemandcuff,areoutsidethescopeofthisspecification.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.2.ReferencedDocuments2.1ASTMStandards:F1242SpecificationforCuffedandUncuffedTrachealTubes2F1497TestMethodforDeterminingtheLaserResistanceoftheShaftofTrachealTubes33.Terminology3.1Definitions—Fordefinitionsotherthanthoselistedbe-lowrefertoSpecificationF1242andTestMethodF1497.3.1.1device—atrachealtubeortrachealtubetreatmentmaterial.3.1.2marking—informationpermanentlyaffixedbythemanufacturertoanysurfaceofatrachealtubeortoanyappliedcomponentofalaserresistanttrachealtubetreatmentthatisaffixedtoorprotectsthecomponentuptothepointitisappliedtothetrachealtube.3.1.3product—commerciallyavailabledeviceinitspack-agedandlabeledform.3.1.4trachealtube—atubetoconveygasesorvaporstoandfromthetrachea.Thistermshallbeusedratherthansynonymssuchas“endotracheal,”“intratracheal,”or“catheter.”3.1.4.1laserresistanttrachealtube—atrachealtubethatisint...
