ASTM F3047M-2015 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations《硬质对硬质关节的高需求髋部模拟器磨损试验标准指南》.pdf
《ASTM F3047M-2015 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations《硬质对硬质关节的高需求髋部模拟器磨损试验标准指南》.pdf》由会员分享,可在线阅读,更多相关《ASTM F3047M-2015 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations《硬质对硬质关节的高需求髋部模拟器磨损试验标准指南》.pdf(8页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F3047M 15Standard 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 las
2、t 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
3、 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
4、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 c
5、omponents 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 TH
6、R 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 eclips
7、ed 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 n
8、otsatisfactory (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
9、 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
10、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-6Mol
11、ybdenum 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 fo
12、r 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 C
13、obalt-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 A
14、rthroplasty.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 ser
15、viceastm.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 Har
16、bor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1Metallic, 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 Test
17、ISO 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 Implant MaterialsPolymer and MetalW
18、ear ParticlesIsolation, Characterization and Quantifi-cation3. Terminology3.1 Definitions:3.1.1 acetabular linerportion of the modular acetabulardevice with an internal hemispherical socket intended toarticulate with the head of a femoral prosthesis. The externalgeometry of this component interfaces
19、 with the acetabular shellthrough a locking mechanism which may be integral to thedesign of the liner and shell or may rely upon additionalcomponents (for example, metal ring, screws, and so forth).3.1.2 acetabular shellthe metallic external, hollow struc-ture that provides additional mechanical sup
20、port or reinforce-ment for an acetabular liner and whose external featuresinterface directly with the bones of the pelvic socket (forexample, through bone cement, intimate press-fit, coatings forattachment to bone cement or tissue, integral screw threads,anchoring screws, pegs, and so forth). The ac
21、etabular shell maybe solid or contain holes for fixation to the pelvis or attachmentof instrumentation.3.1.3 acetabular liner/shell anglethe angle between thepolar axis of the acetabular articulating surface and thehorizontal (see ISO 14242 Part 1 paragraph 7.4).3.1.4 alloy fabricated formthe raw ma
22、terial form of themetallic alloy and any processing techniques used to fabricatethe final form of the implant.3.1.5 breakaway weara higherunexpected wear rate thatfollows a period of steady-state wear as illustrated in Fig. 2.3.1.6 breakaway wear with recoverya breakaway wearrate that returns to the
23、 lower steady state wear rates. Thebreakaway/recovery phenomenon can be a single event or asmultiple episodic events during the otherwise steady-stateconditions as illustrated in Fig. 2.3.1.7 ceramic-on-ceramic hip prosthesisa device intendedto replace a human hip joint in which the ball and cuparti
24、culating surfaces are composed of high purity alumina oralumina matrix composite ceramics. The ball is attached to anintramedullary femoral stem. Device articulating componentsmanufactured from other ceramic materials or with coated orelementally modified surfaces may have special concernswhich are
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