ASTM_F_3047M_-_15.pdf

Designation:F3047M15Standard Guide forHigh Demand Hip Simulator Wear Testing of Hard-on-hardArticulations1This standard is issued under the fixed designation F3047M;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 The objective of this guide is to advise researchers onthe possible high demand wear test features that should beincluded in evaluation of hard on hard articulations.This guidemakes suggestions of what high demand test features may needto be added to an overall high demand wear test regime.Devicearticulating components manufactured from other metallicalloys,ceramics or with coated or elementally modified sur-faces could possibly be evaluated with this guide.Howeversuch materials may include risks and failure mechanismswhich are not adressed in this guide.1.2 Hard-on-hard hip bearing systems include metal-on-metal,ceramic-on-ceramic,ceramic-on-metal,or any otherbearing systems where both the head and cup components havehigh surface hardness.An argument has been made that thehard-on-hard THR articulation may be better for younger moreactive patients.These younger patients may be more physicallyfit and expect to be able to perform more energetic activities.Consequently,new designs of hard-on-hard THR articulationsmay have some implantations subjected to more demandingand longer wear performance requirements.1.3 Total Hip Replacement(THR)with metal-on-metalarticulations have been used clinically for more than 50 years(1,2).2Early designs had mixed clinical results.Eventuallythey were eclipsed by THR systems using metal on polyeth-ylene articulations.In the 1990s the metal-on-metal articula-tion again became popular with more modern designs(3),including surface replacement.1.4 In the 1970s the first ceramic-on-ceramic THR articu-lations were used.In general,the early results were notsatisfactory(4,5).Improvement in alumina,and new designsin the 1990s improved the results for ceramic-on-ceramicarticulations(6).1.5 The values stated in SI units are to be regarded as thestandard.1.6 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:3F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants(UNS R31537,R31538,R31539)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants(UNSR31537,UNS R31538,and UNS R31539)F1814 Guide for Evaluating Modular Hip and Knee JointComponentsF1820 Test Method for Determining the Forces for Disas-sembly of Modular Acetabular DevicesF1877 Practice for Characterization of ParticlesF2033 Specification for Total Hip Joint Prosthesis and HipEndoprosthesis Bearing Surfaces Made of Metallic,Ceramic,and Polymeric Materials2.2 ISO Standards:4ISO 5832-4 Implants for SurgeryMetallic MaterialsPart4:Cobalt-Chromium-Molybdenum Casting AlloyISO 5832-12 Implants for SurgeryMetallic MaterialsPart 12:Wrought Cobalt-Chromium-Molybdenum AlloyISO 7206-2 Implants for SurgeryPartial and Total HipJoint ProsthesesPart 2:Articulating Surfaces Made of1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved March 15,2015.Published May 2015.DOI:10.1520/F3047M-15.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.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.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 Metallic,Ceramic and Plastics MaterialsISO 14242-1 Implants for SurgeryWear of Total Hip-JointProstheses.Part 1:Loading and Displacement Parametersfor Wear-Testing Machines and Corresponding Environ-mental Conditions for TestISO 14242-2 Implants for SurgeryWear of Total Hip-JointProstheses.Part 2:Methods of MeasurementISO 14242-3:2009 Implants for SurgeryWear of TotalHip-Joint ProsthesesPart 3:Loading and DisplacementParameters for Orbital Bearing Type Wear TestingISO 17853 Wear of Implan