Designation:F3044−14TestMethodforStandardTestMethodforEvaluatingthePotentialforGalvanicCorrosionforMedicalImplants1ThisstandardisissuedunderthefixeddesignationF3044;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodcoversconductinggalvaniccorrosionteststocharacterizethebehavioroftwodissimilarmetalsinelectricalcontactthataretobeusedinthehumanbodyasmedicalimplantsorascomponentpartstomedicalimplants.Examplesofthetypesofdevicesthatmightbeassessedincludeoverlappingstentsofdifferentalloys,stentandstentmarkercombinations,orthopedicplatesandscrewswhereoneormoreofthescrewsareofadifferentalloythantherestofthedevice,andmulti-partconstructswheretwoormorealloysareusedforthevariouscomponentparts.Deviceswhicharetobepartiallyimplanted,butinlong-termcontactwithinthebody(suchasexternalfixationdevices)mayalsobeevaluatedusingthismethod.1.2Thistestmethodcoverstheselectionofspecimens,specimenpreparation,testenvironment,methodofexposure,andmethodforevaluatingtheresultstocharacterizethebehaviorofgalvaniccouplesinanelectrolyte.1.3Devicesanddevicecomponentsareintendedtobetestedintheirfinishedcondition,aswouldbeimplanted(thatis,themetallurgicalandsurfaceconditionofthesampleshouldbeinorascloseaspossibletothesameconditionasinthefinisheddevice).1.4Thistestmethoddoesnotaddressothertypesofcorrosionanddegradationdamagethatmayoccurinadevicesuchasfretting,crevices,ortheeffectofanygalvanicallyinducedpotentialsonstresscorrosionandcorrosionfatigue.Surfacemodifications,suchasfromscratches(possiblyintro-ducedduringimplantation)oreffectsofwelding(duringmanufacture),arealsonotaddressed.Thesemechanismsareoutsideofthescopeofthistestmethod.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablis...
