ASTM_F_3044_-_14.pdf

Designation:F304414Test Method forStandard Test Method for Evaluating the Potential forGalvanic Corrosion for Medical Implants1This standard is issued under the fixed designation F3044;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This test method covers conducting galvanic corrosiontests to characterize the behavior of two dissimilar metals inelectrical contact that are to be used in the human body asmedical implants or as component parts to medical implants.Examples of the types of devices that might be assessedinclude overlapping stents of different alloys,stent and stentmarker combinations,orthopedic plates and screws where oneor more of the screws are of a different alloy than the rest of thedevice,and multi-part constructs where two or more alloys areused for the various component parts.Devices which are to bepartially implanted,but in long-term contact within the body(such as external fixation devices)may also be evaluated usingthis method.1.2 This test method covers the selection of specimens,specimen preparation,test environment,method of exposure,and method for evaluating the results to characterize thebehavior of galvanic couples in an electrolyte.1.3 Devices and device components are intended to betested in their finished condition,as would be implanted(thatis,the metallurgical and surface condition of the sample shouldbe in or as close as possible to the same condition as in thefinished device).1.4 This test method does not address other types ofcorrosion and degradation damage that may occur in a devicesuch as fretting,crevices,or the effect of any galvanicallyinduced potentials on stress corrosion and corrosion fatigue.Surface modifications,such as from scratches(possibly intro-duced during implantation)or effects of welding(duringmanufacture),are also not addressed.These mechanisms areoutside of the scope of this test method.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.NOTE1Additional information on galvanic corrosion testing andexamples of the conduct and evaluation of galvanic corrosion tests inelectrolytes are given in Ref.(1).22.Referenced Documents2.1 ASTM Standards:3D1193 Specification for Reagent WaterF2129 Test Method for Conducting Cyclic PotentiodynamicPolarization Measurements to Determine the CorrosionSusceptibility of Small Implant DevicesG1 Practice for Preparing,Cleaning,and Evaluating Corro-sion Test SpecimensG3 Practice for Conventions Applicable to ElectrochemicalMeasurements in Corrosion TestingG5 Reference Test Method for Making PotentiodynamicAnodic Polarization MeasurementsG15 Terminology Relating to Corrosion and Corrosion Test-ing(Withdrawn 2010)4G16 Guide for Applying Statistics to Analysis of CorrosionDataG31 Guide for Laboratory Immersion Corrosion Testing ofMetalsG46 Guide for Examination and Evaluation of Pitting Cor-rosionG59 Test Method for Conducting Potentiodynamic Polariza-tion Resistance MeasurementsG71 Guide for Conducting and Evaluating Galvanic Corro-sion Tests in ElectrolytesG82 Guide for Development and Use of a Galvanic Seriesfor Predicting Galvanic Corrosion PerformanceG102 Practice for Calculation of Corrosion Rates and Re-lated Information from Electrochemical Measurements3.Significance and Use3.1 Implantable medical devices can be made of dissimilarmetals or come into electrical contact with dissimilar metals1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved Jan.15,2014.Published May 2014.DOI:10.1520/F3044-14.2The boldface number in parentheses refers to the reference provided at the endof the document.3For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.4The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 leading to the potential for galvanic corrosion,which mayresult in the release of corrosion products with harmfulbiological consequences or a compromise of structural integ-rity of the device.Therefore,it is important to determine thesusceptibility of these types of devices to galvanic corrosion.3.2 Use of this test method is intended to provide informa-tion on the possible galvanic