ASTM F2477-2007 血管支架的体外脉动持久性测试用标准试验方法

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【英文标准名称】:StandardTestMethodsforinvitroPulsatileDurabilityTestingofVascularStents
【原文标准名称】:血管支架的体外脉动持久性测试用标准试验方法
【标准号】:ASTMF2477-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:(TestMethod)
【标准水平】:()
【中文主题词】:磨损;通路;合金;特征;充气囊;弯曲;生物降解能力;血管;校准;涂覆的;条件;导(线)管;遮盖物;破碎;曲线的;周期的;测定;偏差;疾病;持久性;持续时间;动态的;血管内的;可扩张的;扩张件;水力的;仪器;实验室测试;极限;负荷;测量装置;金属;重叠;个人保健;生理学的;高聚物;压力容器;公
【英文主题词】:durabilitytest;endovascularcardiology;fatiguetest;interventionalcardiology;intravasculardevicetest;pressurecontrol;pulsatilefatigue;stentdurability;stentfatigue;stenttest;straincontrol;vascularstent
【摘要】:1.1Thesetestmethodscoverthedeterminationofthedurabilityofavascularstentbyexposingittophysiologicallyrelevantdiametricdistensionlevelsbymeansofhydrodynamicpulsatileloading.Thistestingoccursonastenttestspecimenthathasbeendeployedintoamock(elasticallysimulated)vessel.Thetypicaldurationofthistestis10yearsofequivalentuse(at72beatsperminute),oratleast380millioncycles.1.2Thesetestmethodsareapplicabletoballoon-expandableandself-expandingstentsfabricatedfrommetalsandmetalalloys.Itdoesnotspecificallyaddressanyattributesuniquetocoatedstents,polymericstents,orbiodegradablestents,althoughtheapplicationofthistestmethodtothoseproductsisnotprecluded.1.3Thesetestmethodsdonotincluderecommendationsforendovasculargrafts("stent-grafts")orotherconduitproductscommonlyusedtotreataneurismaldiseaseorperipheralvesseltraumaortoprovidevascularaccess,althoughsomeinformationincludedhereinmaybeapplicabletothosedevices.1.4Thesetestmethodsarevalidfordeterminingstentfailureduetotypicalcyclicbloodvesseldiametricdistension.Thesetestmethodsdonotaddressothermodesoffailuresuchasdynamicbending,torsion,extension,crushing,orabrasion.1.5Thesetestmethodsdonotaddresstestconditionsforcurvedmockvessels.1.6Thesetestmethodsdonotaddresstestconditionsforoverlappingstents.1.7Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.1.8GeneralCaveat8212;Thisdocumentcontainsguidancefortestingasiscurrentlycarriedoutinmostlaboratories.Othertestingtechniquesmayprovetobemoreeffectiveandareencouraged.Whichevertechniqueisused,itisincumbentuponthetestertojustifytheuseoftheparticulartechnique,instrument,andprotocol.Thisincludesthechoiceofandpropercalibrationofallmeasuringdevices.Deviationsfromanyofthesuggestionsinthisdocumentmaybeappropriatebutmayrequirethesamelevelofcomprehensivejustificationthatthetechniquesdescribedhereinwillrequire.
【中国标准分类号】:C30
【国际标准分类号】:11_040_25
【页数】:10P.;A4
【正文语种】: