Designation:F2942−13StandardGuideforinvitroAxial,Bending,andTorsionalDurabilityTestingofVascularStents1ThisstandardisissuedunderthefixeddesignationF2942;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguideincludesthreeseparatecyclicdeformationdurabilityguidesrelatedtovascularstents:bending,axial,andtorsional.1.2Thisguidedoesnotaddressflatplate,localcrushdurability,ormulti-modetesting.1.3Thisguideappliestoballoon-expandableandself-expandingstentsfabricatedfrommetalsandmetalalloys.Itdoesnotspecificallyaddressanyattributesuniquetocoatedstents(i.e.,stentwithasurfacelayerofanadditionalmaterial(s)),monolithicallypolymericstents,orabsorbablestents,althoughtheapplicationofthisstandardtothoseproductsisnotprecluded.1.4Thisguideisapplicabletotestingofstent(s)(orarepresentativeportionofastent).Whiledurabilitytestingofcouponsamples(e.g.,ascaled-upportionofthestentstructure)canprovideusefulinformation,itisnotwithinthescopeofthisguide.1.5Thisguideappliestoendovasculargrafts(“stent-grafts”)andotherconduitproductscommonlyusedtotreataneurismaldisease,peripheralvesseltrauma,ortoprovidevascularaccess.Theinformationprovidedhereindoesnotaddressallissuesrelatedtotestingofthesedevices.1.6Thisguideappliestoinvitromodelingofstentdurabil-ityfromnon-radialarterialmotions.Suchmotionsmayarisefrommusculoskeletalactivities,includingwalkingandbreathing,andcardiacmotion.ASTMF2477addressespulsa-tile(i.e.,radial)durabilityofvascularstents.1.7Thisguidedoesnotprovidetheinvivophysiologicdeformationconditionsforavascularstent.Itisincumbentupontheuserofthestandardtodevelopandjustifytheseboundaryconditions(e.g.,literaturereview,invivostudies,cadaverstudies,ormodelingofstentvesselinteraction)inthesedurabilitybenchtests.Additionalconditionsthatmaybeconsideredincludevesselcalcificatio...
