ASTM F2606-2008 三点弯曲血管球囊膨胀型支架和支架装置的标准指南

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【英文标准名称】:StandardGuideforThree-PointBendingofBalloonExpandableVascularStentsandStentSystems
【原文标准名称】:三点弯曲血管球囊膨胀型支架和支架装置的标准指南
【标准号】:ASTMF2606-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.30
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:bending;deliverysystem;elasticity;flexibility;flexural;flexure;stent;stentsystem;stiffness
【摘要】:Thisguidecanbeusedtoobtainforceversusdeflectionormidspanbendingmomentversusmidspancurvaturecurvesforstentsandstentsystemssubjectedtothree-pointbendingconditions.Bendingflexibilityofastentsystemmaybeafactorinitsabilitytotrackthroughthevascularanatomy,andmaybeafactorinvasculartraumaalongthedeliverypathwaydistaltotheguidecatheter.Bendingflexibilityofadeployedstentmaybeonemeasureofitsabilitytoflexwithavessel,ortoconformtothenaturalcurvatureofavessel.Bendingflexibilityofadeliverysystemmayalsobeofinterestifitisdesiredtoassesstheseparatecontributionsofthedeliverysystemandthemountedstenttotheoverallflexibilityofthestentsystem.Thisguideisnotintendedtodeterminematerialproperties,stentsystemtrackability(abilityofastentsystemtofollowaguidewireand/orguidecatheterthroughvasculartortuosity),orstentsystemdeliverability(abilityofastentsystemtodeliverastenttotheimplantationsite(s)orthroughparticularlevel(s)ofvasculartortuosity).Whilethisguidedoesnotdeterminestentsystemtrackabilityordeliverability,itcanprovidequantitativeinsightintohowstentsystembendingflexibilityaffectstrackabilityanddeliverability.Similarly,whilethisguidedoesnotdetermineconformabilityofadeployedstent,itcanprovidequantitativeinsightintohowstentand/orstentsystembendingflexibilityaffectsdeployedstentconformability.Sincethisguidequantifiesbendingflexibility,itmaybeusefulindeterminingthemagnitudeofbendingflexibilityeffectsonbending-relatedperformancedifferencesbetweenthetestarticleandcontroldevices.Thethree-pointbendingproceduresprovidedinthisguideareintendedtobeusedtocharacterizeballoon-expandablestentandstentsystemflexibilityduringproductdevelopment.Theymaynotnecessarilysatisfyanyparticularrequirementsofnationalorinternationalregulatorybodies.1.1Thisguideprovidesguidelinesforquantitativelycharacterizingballoon-expandablestentandstentsystemflexibilityusingthree-pointbendingprocedures.Guidelinesareprovidedforcharacterizingdeployedstentflexibility,andforcharacterizingpre-deploymentstentsystemflexibilityintheregionofthestentandballoon.1.2Thisguideisnotrecommendedfortestarticlesthatcannotbeappropriatelyevaluatedusingaspanlengthtostentouterdiameter(astested)ratioofatleast4:1.Testarticlesthatdonotmeetthisrequirementarelikelytoexhibitappreciabledeformationbymodesotherthanbending.1.3Thisguidedoesnotprovideproceduresforcharacterizingthebendingflexibilityofself-expandingstents,self-expandingstentsystems,endoprostheses(stent-grafts),orendoprosthesessystems.However,someaspectsofthisguidemaybeusefulfordevelopingappropriatethree-pointbendingcharacterizationproceduresforthesedevices.Whilethisguidewasdevelopedwithvascularstentsandstentsystemsinmind,itmaybeusefulforcharacterizingthebendingflexibilityofballoon-expandablestentsandstentsystemsusedinnon-vascularapplications.1.4ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesaremathematicalconversionstoinch-poundunitsthatareprovidedforinformationonlyandarenotconsideredstandard.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:6P.;A4
【正文语种】:英语