ASTM F2091-2015 Standard Specification for Acetabular Prostheses《髋臼假体的标准规格》.pdf

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1、Designation: F2091 01 (Reapproved 2012)F2091 15Standard Specification forAcetabular Prostheses1This standard is issued under the fixed designation F2091; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A

2、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 acetabular resurfacing devices used to provide a functioning articulation between the bones of theacetabulum

3、and the femur.1.2 This specification is intended to provide basic descriptions of materials and device geometry. Additionally, thosecharacteristics determined to be important to in vivo performance of the device are defined.1.3 Acetabular prostheses included within the scope of this specification ar

4、e intended for mechanical fixation by press-fitbetween the prosthesis and host bone, by the use of bone cement or through biological fixation.cement, the use of bone screws orsimilar means of mechanical fixation, or through biological fixation of host bone and/or soft connective tissue into a porous

5、 surface.1.4 Custom (designed explicitly for a single patient), revision, or constrained acetabular prostheses are not covered within thescope of this specification.1.5 This specification does not cover the details for quality assurance, design control, production control contained in 21 CFR820 (Qua

6、lity System Regulation) and ISO 9001.2. Referenced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNSR50700)F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgic

7、al Implants (UNSR30075)F86 Practice for Surface Preparation and Marking of Metallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNSR30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Inter

8、stitial) Alloy for Surgical ImplantApplications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants(UNS S31673)F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications(

9、UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical ImplantApplications (UNS R30563) (Withdrawn 2005)3F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsF603 Specification for High-Purity Dense Aluminum

10、Oxide for Medical ApplicationF629 Practice for Radiography of Cast Metallic Surgical ImplantsF648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsF745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solutio

11、n-Annealed SurgicalImplant Applications (Withdrawn 2012)3F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subc

12、ommitteeF04.22 on Arthroplasty.Current edition approved Jan. 15, 2012March 15, 2015. Published January 2012May 2015. Originally approved in 2001. Last previous edition approved in 20062012 asF2091 01 (2006).(2012). DOI: 10.1520/F2091-01R11.10.1520/F2091-15.2 For referencedASTM standards, visit theAS

13、TM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standardsstandards Document Summary page on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM stand

14、ard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM

15、 is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1F748 Practice for Selecting Generic Biological Test Methods for Materials and DevicesF799 Specification for Cobalt-28Chromium-6Molybdenum Alloy

16、 Forgings for Surgical Implants (UNS R31537, R31538,R31539)F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and BoneF983 Practice for Permanent Marking of Orthopaedic Implant ComponentsF1044 Test Method for Shear Testing

17、 of Calcium Phosphate Coatings and Metallic CoatingsF1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic CoatingsF1160 Test Method for Shear and Bending Fatigue Testing of Calcium

18、 Phosphate and Metallic Medical and Composite CalciumPhosphate/Metallic CoatingsF1185 Specification for Composition of Hydroxylapatite for Surgical ImplantsF1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)F1472 Specification for Wrought Tita

19、nium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)F1501 Test Method for Tension Testing of Calcium Phosphate Coatings (Withdrawn 2000)3F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNSR31538, and UNS R31539)F1580 Sp

20、ecification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical ImplantsF1714 Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator DevicesF1820 Test Method for Determining the Forces for Disassembly of Modular Acetabular DevicesF1978 Test Me

21、thod for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber AbraserF2033 Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, andPolymeric MaterialsF2565 Guide for Extensively Irradiation-Crosslinked Ultra-Hi

22、gh Molecular Weight Polyethylene Fabricated Forms for SurgicalImplant ApplicationsF2582 Test Method for Impingement of Acetabular Prostheses2.2 ISO Standards:ISO 58325832-1, -3, -4, -9, -12, -12/Cor:1, -14 Implants for surgeryMetallic materials for surgical implants3ISO 58345834-1, -2, -3, -4, -5 Im

23、plants for surgeryUltra high molecular weight polyethylene3ISO 64746474-1 Implants for surgeryCeramic materials based on high purity alumina3ISO 6474-2 Implants for surgeryCeramic materialsPart 2: Composite materials based on a high-purity alumina matrix withzirconia reinforcement3ISO 9001 Quality s

24、ystemsModel for quality assurance in design/development, production, installation, and servicing3ISO 14242-1 Implants for surgeryWear of total hip-joint prosthesesPart 1: Loading and displacement parameters forwear-testing machines and corresponding environmental conditions for test3ISO 14242-2 Impl

25、ants for surgeryWear of total hip-joint prosthesesPart 2: Methods of measurement3ISO 14242-3 Implants for surgeryWear of total hip joint prosthesesPart 3: Loading and displacement parameters for orbitalbearing type wear testing machines and corresponding environmental conditions for test3ISO 21535 N

26、on-active surgical implantsJoint replacement implantsSpecific requirements for hip-joint replacement implant32.3 Code of Federal Regulations:21 CFR 820 Quality System Regulation43. Terminology3.1 Definitions:3.1.1 bearing element, narticulating surface element between the femoral head and shell or b

27、onding agent (bone cement).3.1.2 cavity, nany slot, cut, hole, or other feature within the shell intended to accommodate modular adjunct fixation elements;instruments for insertion, extraction, and so forth; or for manufacturing purposes.3.1.3 fixation element, nany peg, spike, threadform, or other

28、protrusion from the exterior surface of the shell intended toincrease the surface contact or mechanical interlock between the component, the bonding agent, the natural acetabulum, or acombination thereof.3.1.4 flange, nrim extending from the entry diameter of bearing element.3.1.5 porous coating,sur

29、face, na region on the exterior surface of the shell characterized by interconnecting subsurface pores,generally with volume porosity between 30 and 70 %, average pore size between 100 and 1000 m, and a thickness between 5003 Available from International Organization for Standardization (ISO), 1, ch

30、. de la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http:/www.iso.org.4 Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http:/dodssp.daps.dla.mil.F2091 152and 1500 m. This porous layer may be manufactured directl

31、y into the device by casting or by various electro/chemical/thermal/mechanical means, or applied as a coating of particles, beads, or mesh by processes such as sintering or plasma spray.3.1.6 radiographic marker, nnonstructural, generally thin wire, designed to be apparent on X-rays taken after plac

32、ement ofimplants that otherwise would be unapparent on such X-rays.3.1.7 retention element, nany ring, taper, wire, or other protrusion or cavity from the interior surface of the shell or the exteriorsurface of the bearing element that is intended to affix the bearing element to the shell.3.1.8 shel

33、l, nmetal structure supporting the articulating surface material, and which may be fixed rigidly to the articulatingsurface or fixed such that it allows the articulating surface to rotate or translate.3.1.9 surface texturing, nrepetitive or random deviations from the nominal surface that forms the t

34、hree dimensionaltopography of the surface.3.2 Dimensions of acetabular prostheses should be designated in accordance with Figs. 1-3 or by an equally acceptable anddetailed method.NOTE 1Figs. 1-3 are intended to be illustrative of typical acetabular prostheses and to designate dimensions, but represe

35、ntation of the componentsdoes not otherwise form part of the standard.4. Types4.1 Acetabular prostheses falling within the scope of this specification are of two types, as defined below. There are nodistinguishing features (for example, augmentation or lack thereof, holes, and so forth) that would e

36、xempt any device from anyrequirement of this specification.4.1.1 Type ISingle-piece acetabular prostheses.NOTE 2Specifications to both bearing elements and shell may apply.4.1.2 Type IIMultipiece, modular structure prostheses.5. Material5.1 The choice of materials is understood to be a necessary, bu

37、t not sufficient, assurance of function of the device made fromthem. All devices conforming to this specification shall be fabricated from materials with adequate mechanical strength anddurability, corrosion resistance, and biocompatibility.5.1.1 Mechanical StrengthVarious components of acetabular p

38、rostheses have been successfully fabricated from the followingmaterials: See Specifications F67, F75, F90, F136, F138, F562, F563, F603, F648, F745, F799, F1108, F1185, F1377, F1472,F1537, F1580; and ISO 5832, ISO 5834 and ISO 6474. 5832-1, -3, -4, -9, -12, -12/Cor:1, -14, ISO 5834-1, -2, -3, -4, -5

39、 and ISO6474-1, -2. However, not all of these materials may possess sufficient mechanical strength for critical highly stressed componentsnor for articulating surfaces. Associated standards include Practices F601 and F629 and Guide F2565.Key:SD1 Diameter of spherical socket SR Retention element dist

40、ance from SD2SD2 Retentive or nonretentive entry diameter SH Overall heightSD3 Effective spherical external diameter S Angle from shell face to SC1 centerSC1 Dome cavity diameter (when present) SP1 Fixation element width or diameterSC2 Apical cavity diameter (when present) SP2 Fixation element heigh

41、tSW Minimum wall thickness SP3 Distance to fixation element from shell faceSG Surface texture or coating depthFIG. 1 Shell Cross SectionF2091 1535.1.2 Corrosion ResistanceMaterials with limited or no history of successful use for orthopaedic implant application shall bedetermined to exhibit corrosio

42、n resistance equal to or better than one of the materials listed in 5.1.1 when tested in accordance toTest Method F746.5.1.3 BiocompatibilityMaterials with limited or no history of successful use for orthopaedic implant application mustshall bedetermined to exhibit acceptable biological response equ

43、al to or better than one of the materials listed in 5.1.1 when tested inaccordance to Practices F748 and F981 for a given application.Key:BD2 Retentive or nonretentive entry diameter BH1 Distance from bearing element faceBD3 Relief diameter (entry chamfer, if present, to domeneed not extend through

44、the whole BI Inside depthcircumference) BR Retention element depthBD4 Effective spherical external diameter B Angle of chamfer element from BD2BD5 Outside diameter of the bearing element to BD3BD6 Flange diameter (when present) B Angle of augmentation of anBP Depth of BD2 extended lipBW Minimum wall

45、 thickness BL1 Offset of from center of BD4BF Flange thickness (when present)FIG. 2 Bearing Element Cross SectionKey:BD2 Retentive or nonretentive entry diameter Bd4 Minor effective sphericalBD3 Relief diameter (entry chamfer, if present, external diameterneed not extend through the whole Bd5 Minor

46、external diametercircumference) Bd6 Minor flange diameter (whenBD4 Effective spherical external diameter present)BD5 Major external diameter BE EccentricityBD6 Major flange diameter (when present)FIG. 3 Plan View of Oval/Eccentric Configuration of Bearing Element and ShellF2091 1546. Performance Req

47、uirements6.1 Structural RequirementsAcetabular prostheses conforming to this specification shall be capable of withstanding normalstatic and dynamic loading in the physiological range. It shall also demonstrate wear rates substantially equivalent to or less thansterile ultra-high-molecular-weight po

48、lyethylene (Specification F648) with a cobalt chromium couple. See Test Method F1820 andGuideGuides F1714 and F2565.6.2 Metal and Ceramic Coating or Surface Texture IntegrityThe coating shall be free of detrimental blisters, delaminations,contamination, or poorly defined coating boundaries when view

49、ed with no magnification. It shall not fail by spalling, cracking,detrimental material loss, or detrimental degradation.The following test methods shall be used (if applicable):Test Methods F1044,F1147, F1160, F1501, and F1978.NOTE 3In situations in which these tests may not be considered appropriate, other test methods may be considered.6.3 There are relevant failure modes listed below which, at a minimum, shall be considered in the evaluation of the safety andefficacy of an acetabular prosthesis. The failure modes may be addressed t