ASTM_F_1714_-_96_2018.pdf

Designation:F171496(Reapproved 2018)Standard Guide forGravimetric Wear Assessment of Prosthetic Hip Designs inSimulator Devices1This standard is issued under the fixed designation F1714;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 guide describes a laboratory method using aweight-loss technique for evaluating the wear properties ofmaterials or devices,or both,which are being considered foruse as bearing surfaces of human-hip-joint replacement pros-theses.The hip prostheses are evaluated in a device intended tosimulate the tribological conditions encountered in the humanhip joint,for example,use of a fluid such as bovine serum,orequivalent pseudosynovial fluid shown to simulate similarwear mechanisms and debris generation as found in vivo,andtest frequencies of 1 Hz or less.1.2 Since the hip simulator method permits the use of actualimplant designs,materials,and physiological load/motioncombinations,it can represent a more physiological simulationthan basic wear-screening tests,such as pin-on-disk(seePractice F732)or ring-on-disk(see ISO 6474).1.3 It is the intent of this guide to rank the combination ofimplant designs and materials with regard to material wear-rates,under simulated physiological conditions.It must berecognized,however,that there are many possible variations inthe in vivo conditions,a single laboratory simulation with afixed set of parameters may not be universally representative.1.4 The reference materials for the comparative evaluationof candidate materials,new devices,or components,or acombination thereof,shall be the wear rate of extruded orcompression-molded,ultra-high molecular weight(UHMW)polyethylene(see Specification F648)bearing against standardcounter faces stainless steel(see Specification F138);cobalt-chromium-molybdenum alloy(see Specification F75);thermo-mechanically processed cobalt chrome(see SpecificationF799);alumina ceramic(see Specification F603),havingtypical prosthetic quality,surface finish,and geometry similarto those with established clinical history.These referencematerials will be tested under the same wear conditions as thecandidate materials.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D883 Terminology Relating to PlasticsF75 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 ImplantsF136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI(Extra Low Interstitial)Alloy for SurgicalImplant Applications(UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F370 Specification for Proximal Femoral Endoprosthesis(Withdrawn 2005)3F565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF603 Specification for High-Purity Dense Aluminum Oxidefor Medical ApplicationF648 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 Prostheses1This 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 April 1,2018.Published May 2018.Originallyapproved in 1996.Last previous edition approved in 2013 as F1714 96(2013).DOI:10.1520/F1714-96R18.2For 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.3The 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 StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 F799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants(UNS R31537,R31538,R31539)G40 Termin