1、Designation:F171496(Reapproved 2013)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
2、,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 ofmat
3、erials 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,or
4、equivalent 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
5、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 be
6、recognized,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 acombin
7、ation 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 process
8、ed 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 valu
9、es stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.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(UN
10、S 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
11、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 Ultr
12、a-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF732 Test Method for Wear Testing of Polymeric MaterialsUsed in Total Joint ProsthesesF799 Specification for Cobalt-28Chromium-6Molybdenum1This guide is under the jurisdiction of ASTM Committee F04 on Medical andS
13、urgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved March 15,2013.Published April 2013.Originallyapproved in 1996.Last previous edition approved in 2008 as F1714 96(2008).DOI:10.1520/F1714-96R13.2For referenced ASTM standards,
14、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 AST
15、M International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 Alloy Forgings for Surgical Implants(UNS R31537,R31538,R31539)G40 Terminology Relating to Wear and Erosion2.2 ISO Standard:ISO 6474 Implants for SurgeryCeramic Materials Based onAlumina43.Significance an
16、d Use3.1 This guide uses a weight-loss method of wear determi-nation for the polymeric components used with hip jointprostheses,using serum or demonstrated equivalent fluid forlubrication,and running under a dynamic load profile repre-sentative of the human hip-joint forces during walking(1,2).5The basis for this weight-loss method for wear measurementwas originally developed(3)for pin-on-disk wear studies(seePractice F732)and has been extended to total hip replacements(4,5)femoral-tibial knee p
