ASTM_F_3160_-_16.pdf

Designation:F316016Standard Guide forMetallurgical Characterization of Absorbable MetallicMaterials for Medical Implants1This standard is issued under the fixed designation F3160;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 guidance document provides metallurgical charac-terization information that may be beneficial in the evaluationof absorbable metallic materials intended for medical implantapplications.This guide is primarily intended for absorbablemetallic materials that undergo further processing into afabricated final device.Therefore,this standard does notrequire assessments that are more appropriately conducted onthe final device,such as biological evaluation.However,a fewrelevant standards for finished implant devices are included forinformation purposes.1.2 The purpose of this guide is to identify appropriate testmethods and relevant medical product standards that can beused to develop future standards for new or modified absorb-able metallic materials.1.3 This guide is not intended to cover other major classesof absorbable materials such as polymers,ceramics,composites,and tissue-engineered materials.1.4 This standard guide is focused on the chemical,physical,microstructural,and mechanical properties plus in-spection guidelines for metallic materials that are used formedical implants designed to be absorbed in the body over aperiod of time.This guide focuses on material characteriza-tions and does not address device specific mechanical testingthat may be necessary to determine safety and functionality ofthe implant.1.5 Compliance with materials specifications developed inaccordance with this standard may not necessarily result in amaterial suitable for its intended purpose.Additional testingspecific to the intended use may be required.1.6 Since surface modifications of medical implants aregenerally applied in the latter stages of manufacturing,thisstandard guide does not cover the characterization of eitherabsorbable or non-absorbable surface coatings that are metallicin origin such as oxides or from the addition of other materialssuch as ceramics or polymers.However,this standard doesapply to absorbable metallic materials,regardless of thepresence or absence of a coating.1.7 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.2.Referenced Documents2.1 ASTM Standards:2A262 Practices for Detecting Susceptibility to IntergranularAttack in Austenitic Stainless SteelsA342/A342M Test Methods for Permeability of WeaklyMagnetic MaterialsA480/A480M Specification for General Requirements forFlat-Rolled Stainless and Heat-Resisting Steel Plate,Sheet,and StripA484/A484M Specification for General Requirements forStainless Steel Bars,Billets,and ForgingsA555/A555M Specification for General Requirements forStainless Steel Wire and Wire RodsA751 Test Methods,Practices,and Terminology for Chemi-cal Analysis of Steel ProductsA957 Specification for Investment Castings,Steel andAlloy,Common Requirements,for General Industrial UseB69 Specification for Rolled ZincB80 Specification for Magnesium-Alloy Sand CastingsB86 Specification for Zinc and Zinc-Aluminum(ZA)AlloyFoundry and Die CastingsB90/B90M Specification for Magnesium-Alloy Sheet andPlateB107/B107M Specification for Magnesium-Alloy ExtrudedBars,Rods,Profiles,Tubes,and WireB199 Specification for Magnesium-Alloy Permanent MoldCastingsB403 Specification for Magnesium-Alloy Investment Cast-ings1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved April 1,2016.Published May 2016.DOI:10.1520/F316016.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 B557M Test Methods for Tension Testing Wrought and CastAluminum-and Magnesium-Alloy Products(Metric)B661 Practice for Heat Treatment of Magnesium AlloysB949 Specification for General Requirements for Zinc andZinc Alloy ProductsB953 Practice for Sampling Magnesium and MagnesiumAlloys for Spectrochemical AnalysisB954 Test Method for Analysis of Magnesium and Magne-sium Alloys by Atomic Emission SpectrometryD3648 Practices for the Measurement of RadioactivityE8/E8M Test Methods for Tension Testing of