ASTM F2091-2001(2012) Standard Specification for Acetabular Prostheses《髋臼假体标准规格》.pdf

1、Designation: F2091 01 (Reapproved 2012)Standard 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 number i

2、n 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 devicesused to provide a functioning articulation between the bones ofthe acetabulum and the f

3、emur.1.2 This specification is intended to provide basic descrip-tions of materials and device geometry. Additionally, thosecharacteristics determined to be important to in vivo perfor-mance of the device are defined.1.3 Acetabular prostheses included within the scope of thisspecification are intend

4、ed for mechanical fixation between theprosthesis and host bone, by the use of bone cement or throughbiological fixation.1.4 Custom (designed explicitly for a single patient), revi-sion, or constrained acetabular prostheses are not coveredwithin the scope of this specification.1.5 This specification

5、does not cover the details for qualityassurance, design control, production control contained in 21CFR 820 (Quality System Regulation) and ISO 9001.2. Referenced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550

6、, UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Me-tallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Im

7、plant Applica-tions (UNS R30605)F136 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)F

8、562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563)3F601 Practice for Fluorescent Penet

9、rant Inspection of Me-tallic Surgical ImplantsF603 Specification for High-Purity Dense Aluminum Oxidefor Medical ApplicationF629 Practice for Radiography of Cast Metallic SurgicalImplantsF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plant

10、sF745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsF746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Meth-ods for Materials an

11、d DevicesF799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)F981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF983 Practice for Permanent Marking o

12、f Orthopaedic Im-plant ComponentsF1044 Test Method for Shear Testing of Calcium PhosphateCoatings and Metallic Coatings1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplas

13、ty.Current edition approved Jan. 15, 2012. Published January 2012. Originallyapproved in 2001. Last previous edition approved in 2006 as F2091 01 (2006).DOI: 10.1520/F2091-01R11.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org.

14、For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA

15、 19428-2959, United States.F1108 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 Me

16、dical and Compos-ite Calcium Phosphate/Metallic CoatingsF1185 Specification for Composition of Hydroxylapatite forSurgical ImplantsF1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants(UNS R30075)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium A

17、lloy for Surgical Implant Applications (UNSR56400)F1501 Test Method for Tension Testing of Calcium Phos-phate Coatings (Discontinued 2000)3F1537 Specification for Wrought Cobalt-28Chromium-6MolybdenumAlloys for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)F1580 Specification for Titanium

18、 and Titanium-6Aluminum-4 Vanadium Alloy Powders for Coatings ofSurgical ImplantsF1714 Guide for Gravimetric Wear Assessment of Pros-thetic Hip Designs in Simulator DevicesF1820 Test Method for Determining the Axial DisassemblyForce of a Modular Acetabular DeviceF1978 Test Method for Measuring Abras

19、ion Resistance ofMetallic Thermal Spray Coatings by Using the TaberAbraserF2033 Specification for Total Hip Joint Prosthesis and HipEndoprosthesis Bearing Surfaces Made of Metallic, Ce-ramic, and Polymeric Materials2.2 ISO Standards:ISO 5832 Implants for surgeryMetallic materials for sur-gical impla

20、nts4ISO 5834 Implants for surgeryUltra high molecularweight polyethylene4ISO 6474 Implants for surgeryCeramic materials basedon high purity alumina4ISO 9001 Quality systemsModel for quality assurance indesign/development, production, installation, and servic-ing42.3 Code of Federal Regulations:21 CF

21、R 820 Quality System Regulation53. Terminology3.1 Definitions:3.1.1 bearing element, narticulating surface element be-tween the femoral head and shell or bonding agent (bonecement).3.1.2 cavity, nany slot, cut, hole, or other feature withinthe shell intended to accommodate modular adjunct fixationel

22、ements; instruments for insertion, extraction, and so forth; orfor manufacturing purposes.3.1.3 fixation element, nany peg, spike, threadform, orother protrusion from the exterior surface of the shell intendedto increase the surface contact or mechanical interlock betweenthe component, the bonding a

23、gent, the natural acetabulum, or acombination thereof.3.1.4 flange, nrim extending from the entry diameter ofbearing element.3.1.5 porous coating, na region on the exterior surface ofthe shell characterized by interconnecting subsurface pores,generally with volume porosity between 30 and 70 %, avera

24、gepore size between 100 and 1000 m, and a thickness between500 and 1500 m. This porous layer may be manufactureddirectly into the device by casting or by various electro/chemical/thermal/mechanical means, or applied as a coating ofparticles, beads, or mesh by processes such as sintering orplasma spr

25、ay.3.1.6 radiographic marker, nnonstructural, generally thinwire, designed to be apparent on X-rays taken after placementof implants that otherwise would be unapparent on suchX-rays.3.1.7 retention element, nany ring, taper, wire, or otherprotrusion or cavity from the interior surface of the shell o

26、r theexterior surface of the bearing element that is intended to affixthe bearing element to the shell.3.1.8 shell, nmetal structure supporting the articulatingsurface material, and which may be fixed rigidly to thearticulating surface or fixed such that it allows the articulatingsurface to rotate o

27、r translate.3.1.9 surface texturing, nrepetitive or random deviationsfrom the nominal surface that forms the three dimensionaltopography of the surface.3.2 Dimensions of acetabular prostheses should be desig-nated in accordance with Figs. 1-3 or by an equally acceptableand detailed method.NOTE 1Figs

28、. 1-3 are intended to be illustrative of typical acetabularprostheses and to designate dimensions, but representation of the compo-nents does not otherwise form part of the standard.4. Types4.1 Acetabular prostheses falling within the scope of thisspecification are of two types, as defined below. Th

29、ere are nodistinguishing features (for example, augmentation or lackthereof, holes, and so forth) that would exempt any device fromany requirement 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 IIMulti

30、piece, modular structure prostheses.5. Material5.1 The choice of materials is understood to be a necessary,but not sufficient, assurance of function of the device madefrom them.All devices conforming to this specification shall befabricated from materials with adequate mechanical strengthand durabil

31、ity, corrosion resistance, and biocompatibility.5.1.1 Mechanical StrengthVarious components of ac-etabular prostheses have been successfully fabricated from the4Available from International Organization for Standardization (ISO), 1, ch. dela Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http:/

32、www.iso.org.5Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http:/dodssp.daps.dla.mil.F2091 01 (2012)2following materials: See Specifications F67, F75, F90, F136,F138, F562, F563, F603, F648, F745, F799, F1108, F1185,F13

33、77, F1472, F1537, F1580; and ISO 5832, ISO 5834 andISO 6474. However, not all of these materials may possesssufficient mechanical strength for critical highly stressed com-ponents nor for articulating surfaces. Associated standardsinclude Practices F601 and F629.5.1.2 Corrosion ResistanceMaterials w

34、ith limited or nohistory of successful use for orthopaedic implant applicationshall be determined to exhibit corrosion resistance equal to orbetter than one of the materials listed in 5.1.1 when tested inaccordance to Test Method F746.5.1.3 BiocompatibilityMaterials with limited or no his-tory of su

35、ccessful use for orthopaedic implant application mustbe determined to exhibit acceptable biological response equalto or better than one of the materials listed in 5.1.1 when testedin accordance to Practices F748 and F981 for a given applica-tion.Key:SD1 Diameter of spherical socket SR Retention elem

36、ent distance from SD2SD2 Retentive or nonretentive entry diameter SH Overall heightSD3 Effective spherical external diameter SV 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 elem

37、ent heightSW Minimum wall thickness SP3 Distance to fixation element from shell faceSG Surface texture or coating depthFIG. 1 Shell Cross SectionKey:BD2 Retentive or nonretentive entry diameter BH1 Distance from bearing element faceBD3 Relief diameter (entry chamfer, if present, to domeneed not exte

38、nd through the whole BI Inside depthcircumference) BR Retention element depthBD4 Effective spherical external diameter Bv Angle of chamfer element from BD2BD5 Outside diameter of the bearing element to BD3BD6 Flange diameter (when present) BV Angle of augmentation of anBP Depth of BD2 extended lipBW

39、 Minimum wall thickness BL1 Offset of b from center of BD4BF Flange thickness (when present)FIG. 2 Bearing Element Cross SectionF2091 01 (2012)36. Performance Requirements6.1 Structural RequirementsAcetabular prostheses con-forming to this specification shall be capable of withstandingnormal static

40、and dynamic loading in the physiological range.It shall also demonstrate wear rates substantially equivalent toor less than sterile ultra-high-molecular-weight polyethylene(Specification F648) with a cobalt chromium couple. See TestMethod F1820 and Guide F1714.6.2 Metal and Ceramic Coating or Surfac

41、e TextureIntegrityThe coating shall be free of detrimental blisters,delaminations, contamination, or poorly defined coatingboundaries when viewed with no magnification. It shall not failby spalling, cracking, detrimental material loss, or detrimentaldegradation. The following test methods shall be u

42、sed (ifapplicable): Test Methods F1044, F1147, F1160, F1501, andF1978.NOTE 3In situations in which these tests may not be consideredappropriate, other test methods may be considered.6.3 There are relevant failure modes listed below which, ata minimum, shall be considered in the evaluation of safety

43、andefficacy of an acetabular prosthesis. The failure modes may beaddressed through relevant physical testing, or analyticalanalysis (for example, internal stress analysis as a result ofloading).NOTE 4There is no current ASTM standard for analytical analysis,but this is an important consideration. Te

44、sting may encompass somecombination of static and dynamic loading environments.6.3.1 Component DisassociationDevices made from mul-tiple layers or components have disassociated under clinicaluse (for example, articulating surface from the shell, porouscoating from the shell, and so forth). See Test

45、Method F1820.6.3.2 Fixation FailureDevices have loosened at the inter-face with the bone or bone cement. Fixation elements havefailed.6.3.3 Device FracturePartial or complete fracture of ei-ther the bearing element or the shell.6.3.4 Articular Surface WearAcetabular prostheses havefailed because of

46、excessive wear through the bearing elementresulting in particle debris (see Guide F1714).7. Dimensions7.1 Acetabular prostheses conforming to this specificationshould be fabricated in accordance with the general configu-ration illustrated in Figs. 1-3.7.2 If one of the components is not radiopaque,

47、it may beappropriately marked for radiographic evaluation. Radio-graphic markers have been used in the past and are considerednoncritical and may not be necessary. If a radiographic markeris used, it should be placed in a noncritical area to avoiddegrading the structural and functional properties of

48、 the device.8. Finish and Appearance8.1 Bearing Element FinishAcetabular prostheses con-forming to this specification shall be finished in accordancewith Specification F2033.8.2 In accordance with Practices F86 and F983, itemsconforming to this specification shall be marked as follows inorder of pri

49、ority where space permits: manufacturer, material,lot number, catalog number, and size. Additional informationmay include a designation for alignment.9. Supplementary Requirements9.1 Sterilization:Key: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 external diametercircumference) Bd6 Minor flange diameter (whenBD4 Effective spherical external diameter present)BD5 Major external diameter BE EccentricityBD6 Major flan