Designation:F2394−07(Reapproved2013)StandardGuideforMeasuringSecurementofBalloonExpandableVascularStentMountedonDeliverySystem1ThisstandardisissuedunderthefixeddesignationF2394;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguideprovidesguidanceforthedesignanddevel-opmentofpre-testtreatments,tests,andtestendpointstomeasurestentsecurementofpre-mounted,unsheathed,balloon-expandablestentdeliverysystems.Thisguideisin-tendedtoaidinvestigatorsinthedesign,development,andinvitrocharacterizationofpre-mounted,unsheathed,balloon-expandablestentdeliverysystems.1.2Thisguidecoversthelaboratorydeterminationoftheshearforcerequiredtodisplaceordislodgeaballoon-expandableendovascularstentmountedonadeliverysystem.Theguideproposesasetofoptionstoconsiderwhentestingstentsecurement.Theoptionscoverpre-testtreatments,pos-siblestentsecurementtests,andrelevanttestendpoints.Anexampletestapparatusisgivenin7.1.1.3Thisguidecoversinvitrobenchtestingcharacterizationonly.Measuredlevelsofsecurementandproductdesign/processdifferentiationmaybeparticularlyinfluencedbyselec-tionsofpre-testtreatments,securementtesttype(forexample,stentgrippingmethod),andtestendpoint.Invivocharacteris-ticsmayalsodifferfrominvitroresults.1.4Thisguidedoesnotcoverallpossiblepre-testtreatments,stentsecurementtests,ortestendpoints.Itisintendedtoprovideastartingpointfromwhichtoselectandinvestigatesecurementtestoptions.1.5Thisguidedoesnotspecifyamethodformountingthestentontothedeliverysystem.1.6ThevaluesstatedineitherSIunitsorinch-poundunitsaretoberegardedseparatelyasstandard.Thevaluesstatedineachsystemmaynotbeexactequivalents;therefore,eachsystemshallbeusedindependentlyoftheother.Combiningvaluesfromthetwosystemsmayresultinnon-conformancewiththestandard.1.7Thisstandarddoesnotpurporttoaddressallofthesafetyco...
