Designation:F2081−06(Reapproved2017)StandardGuideforCharacterizationandPresentationoftheDimensionalAttributesofVascularStents1ThisstandardisissuedunderthefixeddesignationF2081;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguidecoverstheidentificationofandrecom-mendedmeasurementmethodsforthosedimensionalattributesofvascularstentsthataredeemedrelevanttosuccessfulclinicalperformance.Thedeliverysystempackagedwithandlabeledspecificallyforuseduringtheplacementofthestentisalsoincludedwithinthescopeofthisguide.1.2Thisguideaddressesonlythedimensionalcharacteris-ticsofstents.Materialpropertyandstentfunctionalcharacter-isticsarenotaddressedherein.Alldimensionalcharacteristicsdescribedinthisguiderefertoinvitro(“bench-top”)charac-terization.Becauseofvariablepatientfactors,forexample,vesselcompliance,theactualinvivocharacteristicsmaybeslightlydifferent.1.3Thisguideincludesrecommendationsgenerallyappli-cabletoballoon-expandableandself-expandingstentsfabri-catedfrommetalsandmetalalloys.Itdoesnotspecificallyaddressanyattributesuniquetocoatedstentsorpolymericorbiodegradablestents,althoughtheapplicationofthisguidetothoseproductsisnotprecluded.1.4Whiletheyarenotspecificallyincludedwithinthescopeofthisguide,stentsindicatedforplacementinnonvascularlocations,suchastheesophagusorbileduct,alsomightbecharacterizedbythemethodscontainedherein.Likewise,thisguidedoesnotincluderecommendationsforendovasculargrafts(“stent-grafts”)orotherconduitdevicescommonlyusedtotreataneurysmaldiseaseorperipheralvesseltraumaortoprovidevascularaccess,althoughsomeinformationincludedhereinmaybeapplicabletothosedevices.1.5Thisguidedoesnotincluderecommendationsforbal-looncatheterssoldasstand-aloneangioplastycatheters,eventhoughsomeofthosecathetersmaybeusedforthedeliveryofunmountedstentssup...
