Designation:F2129−19aStandardTestMethodforConductingCyclicPotentiodynamicPolarizationMeasurementstoDeterminetheCorrosionSusceptibilityofSmallImplantDevices1ThisstandardisissuedunderthefixeddesignationF2129;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodassessesthecorrosionsusceptibilityofsmall,metallic,implantmedicaldevices,orcomponentsthereof,usingcyclic(forwardandreverse)potentiodynamicpolarization.Examplesofdevicetypesthatmaybeevaluatedbythistestmethodinclude,butarenotlimitedto,vascularstents,ureteralstents(SpecificationF1828),filters,supportsegmentsofendovasculargrafts,cardiacoccluders,aneurysmorligationclips,staples,andsoforth.1.2Thistestmethodisusedtoassessadeviceinitsfinalformandfinish,asitwouldbeimplanted.Thesesmalldevicesshouldbetestedintheirentirety.Theupperlimitondevicesizeisdictatedbytheelectricalcurrentdeliverycapabilityofthetestapparatus(seeSection6).Itisassumedthattestmethods,suchasReferenceTestMethodG5andTestMethodG61havebeenusedformaterialscreening.1.3Becauseofthevarietyofconfigurationsandsizesofimplants,thistestmethodprovidesavarietyofspecimenholderconfigurations.1.4Thistestmethodisintendedforuseonimplantabledevicesmadefrommetalswitharelativelyhighresistancetocorrosion.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafety,health,andenvironmentalpracticesanddeter-minetheapplicabilityofregulatorylimitationspriortouse.1.7Thisinternationalstandardwasdevelopedinaccor-dancewithinternationallyrecognizedprinciplesonstandard-izationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,Guidesa...
