【英文标准名称】:StandardTestMethodforConductingCyclicPotentiodynamicPolarizationMeasurementstoDeterminetheCorrosionSusceptibilityofSmallImplantDevices
【原文标准名称】:进行循环动电位极化测量以测定小型植入装置的腐蚀敏感性的标准试验方法
【标准号】:ASTMF2129-2006
【标准状态】:现行
【国别】:
【发布日期】:2006
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:F04.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:腐蚀;耐腐蚀性;腐蚀试验;敏感性测定;测量;外科植入物;灵敏性;试验方法
【英文主题词】:corrosion;cyclicpolarization;medicaldevicetesting;pittingpotential;protectionpotential;restpotential;
【摘要】:Corrosionofimplantablemedicaldevicescanhavedeleteriouseffectsonthedeviceperformanceormayresultinthereleaseofcorrosionproductswithharmfulbiologicalconsequences;therefore,itisimportanttodeterminethegeneralcorrosionbehavioraswellasthesusceptibilityofthedevicestolocalizedcorrosion.Theformingandfinishingstepsusedtocreateanimplantabledevicemayhavesignificanteffectsonthecorrosionresistanceofthematerialoutofwhichthedeviceisfabricated.Duringtheselectionprocessofamaterialforuseasanimplantabledevice,testingthecorrosionresistanceofthematerialisanessentialstep;however,itdoesnotnecessarilyprovidecriticaldataregardingdeviceperformance.Toaccommodatethewidevarietyofdeviceshapesandsizesencountered,avarietyofholdingdevicescanbeused.Notethatthemethodisintentionallydesignedtoreachconditionsthataresufficientlyseveretocausebreakdownanddeteriorationofthemedicaldevicesandthattheseconditionsmaynotbenecessarilyencounteredinvivo.Theresultsofthiscorrosiontestconductedinartificialphysiologicalelectrolytescanprovideusefuldataforcomparisonofdifferentdevicematerials,designs,ormanufacturingprocesses.However,notethatthistestmethoddoesnottakeintoaccounttheeffectsofcells,proteins,andsoforthonthecorrosionbehaviorinvivo.1.1Thistestmethodassessesthecorrosionsusceptibilityofsmall,metallic,implantmedicaldevices,orcomponentsthereof,usingcyclic(forwardandreverse)potentiodynamicpolarization.Examplesofdevicetypesthatmaybeevaluatedbythistestmethodinclude,butarenotlimitedto,vascularstents,ureteralstents(SpecificationF1828),filters,supportsegmentsofendovasculargrafts,cardiacoccluders,aneurysmorligationclips,staples,andsoforth.1.2Thistestmethodisusedtoassessadeviceinitsfinalformandfinish,asitwouldbeimplanted.Thesesmalldevicesshouldbetestedintheirentirety.Theupperlimitondevicesizeisdictatedbytheelectricalcurrentdeliverycapabilityofthetestapparatus(seeSection).Itisassumedthattestmethods,suchasReferenceTestMethodG5andTestMethodG61havebeenusedformaterialscreening.1.3Becauseofthevarietyofconfigurationsandsizesofimplants,thistestmethodprovidesavarietyofspecimenholderconfigurations.1.4Thistestmethodisintendedforuseonimplantabledevicesmadefrommetalswitharelativelyhighresistancetocorrosion.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:8P.;A4
【正文语种】: