ASTM_F_2887_-_12.pdf

Designation:F288712Standard Specification forTotal Elbow Prostheses1This standard is issued under the fixed designation F2887;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 specification covers total elbow replacement(TER)prostheses and hemi-elbow replacement(“hemi”)prosthesesused to provide functioning articulation by employing humeral,ulnar,and/or radial components that allow for the restoration ofmotion of the human elbow joint complex.1.2 Included within the scope of this specification are elbowprosthesis components for primary and revision surgery withlinked and non-linked designs and components implanted withor without use of bone cement.1.3 This specification is intended to provide basic descrip-tions of material and prosthesis geometry.In addition,thosecharacteristics determined to be important to the in vivoperformance of the prosthesis are defined.However,compli-ance with this specification does not itself mean that a devicethat will provide satisfactory clinical performance.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.2.Referenced Documents2.1 ASTM Standards:2F75 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 ImplantsF90 SpecificationforWroughtCobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions(UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI(Extra Low Interstitial)Alloy for SurgicalImplant Applications(UNS R56401)F451 Specification for Acrylic Bone CementF565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF732 Test Method for Wear Testing of Polymeric MaterialsUsed in Total Joint ProsthesesF746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants(UNS R31537,R31538,R31539)F983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1044 Test Method for Shear Testing of Calcium PhosphateCoatings and Metallic CoatingsF1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants(UNS R56406)F1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic CoatingsF1160 Test Method for Shear and Bending Fatigue Testingof Calcium Phosphate and Metallic Medical and Compos-ite Calcium Phosphate/Metallic CoatingsF1223 Test Method for Determination of Total Knee Re-placement ConstraintF1377 Specification for Cobalt-28Chromium-6MolybdenumPowder for Coating of Orthopedic Implants(UNSR30075)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications(UNSR56400)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants(UNSR31537,UNS R31538,and UNS R31539)F1580 SpecificationforTitaniumandTitanium-6Aluminum-4 Vanadium Alloy Powders for Coatings ofSurgical ImplantsF1814 Guide for Evaluating Modular Hip and Knee JointComponentsF2759 Guide for Assessment of the Ultra High MolecularWeight Polyethylene(UHMWPE)Used in Orthopedic andSpinal Devices1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Dec.15,2012.Published March 2013.DOI:10.1520/F288712.2For 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 2.2 ISO Standards:3ISO 58323 Implants for SurgeryMetallic MaterialsPart 3:Wrought Titanium 6-Aluminum 4-Vandium AlloyISO 58324 Implants for SurgeryMetallic MaterialsPart 4:Cobalt-Chromium-Molybdenum Casting AlloyISO 583212 Implants for SurgeryMetallic MaterialsPart 12:Wrought Cobalt-Chromium-Molybdenum AlloyISO 58342 Implants for SurgeryUltra High MolecularWeight PolyethylenePart 2:Moulded FormsISO 6018 Orthopaedic ImplantsGeneral Requirements forMarking,Packaging,and LabelingISO 10993 Biological Evaluation of Medical DevicesPartI:Evaluation and Testing Within a Risk ManagementProcessISO 142431 Implants for SurgeryWear of Total Knee-Joint ProsthesesPart 1:Loading and Displacement Pa-rameters for Wear-testing Machines wi