ASTM F2091-2001(2006) Standard Specification for Acetabular Prostheses《碟状体菌柄标准规范》.pdf

1、Designation: F 2091 01 (Reapproved 2006)Standard Specification forAcetabular Prostheses1This standard is issued under the fixed designation F 2091; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number

2、 in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 th

3、e femur.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 int

4、ended 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 specificati

5、on 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, UNSR50

6、550, 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 Surgica

7、l Implant Applica-tions (UNS R30605)F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S3

8、1673)F 562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F 563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563)3F 601 Practice for Fluoresc

9、ent Penetrant Inspection of Me-tallic Surgical ImplantsF 603 Specification for High-Purity Dense Aluminum Ox-ide for Medical ApplicationF 629 Practice for Radiography of Cast Metallic SurgicalImplantsF 648 Specification for Ultra-High-Molecular Weight Poly-ethylene Powder and Fabricated Form for Sur

10、gical Im-plantsF 745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsF 746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF 748 Practice for Selecting Generic Biological Test Meth-ods

11、 for Materials and DevicesF 799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF 983 Practice for

12、 Permanent Marking of Orthopaedic Im-plant ComponentsF 1044 Test Method for Shear Testing of Calcium Phos-phate Coatings and Metallic CoatingsF 1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants (UNS R56406)F 1147 Test Method for Tension Testing of Calcium Phos-p

13、hate and Metallic CoatingsF 1160 Test Method for Shear and Bending Fatigue Testingof Calcium Phosphate and Metallic Medical and Compos-ite Calcium Phosphate/Metallic Coatings1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the di

14、rect responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved March 1, 2006. Published April 2006. Originallyapproved in 2001. Last previous edition approved in 2001 as F 2091 01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Servic

15、e at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 1185 Specification for Compositio

16、n of Hydroxylapatitefor Surgical ImplantsF 1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants(UNS R30075)F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)F 1501 Test Method for Tension Testing

17、 of Calcium Phos-phate Coatings3F 1537 Specification for Wrought Cobalt-28 Chromium-6Molybdenum Alloy for Surgical ImplantsF 1580 Specification for Titanium and Titanium-6Aluminum-4 Vanadium Alloy Powders for Coatings ofSurgical ImplantsF 1714 Guide for Gravimetric Wear Assessment of Pros-thetic Hip

18、-Designs in Simulator DevicesF 1820 Test Method for Determining theAxial DisassemblyForce of a Modular Acetabular DeviceF 1978 Test Method for Measuring Abrasion Resistance ofMetallic Thermal Spray Coatings by Using the TaberyAbraserF 2033 Specification for Total Hip Joint Prosthesis and HipEndopros

19、thesis Bearing Surfaces Made of Metallic, Ce-ramic, and Polymeric Materials2.2 ISO Standards:ISO 5832 Implants for surgeryMetallic materials for sur-gical implants4ISO 5834 Implants for surgeryUltra high molecularweight polyethylene4ISO 6474 Implants for surgeryCeramic materials basedon alumina4ISO

20、9001 Quality systemsModel for quality assurance indesign/development, production, installation, and servic-ing42.3 Code of Federal Regulations:21 CFR 820 Quality System Regulation53. Terminology3.1 Definitions:3.1.1 bearing element, narticulating surface element be-tween the femoral head and shell o

21、r bonding agent (bonecement).3.1.2 cavity, nany slot, cut, hole, or other feature withinthe shell intended to accommodate modular adjunct fixationelements; instruments for insertion, extraction, and so forth; orfor manufacturing purposes.3.1.3 fixation element, nany peg, spike, threadform, orother p

22、rotrusion from the exterior surface of the shell intendedto increase the surface contact or mechanical interlock betweenthe component, the bonding agent, or the natural acetabulum ora combination thereof.3.1.4 flange, nrim extending from the entry diameter ofbearing element.3.1.5 porous coating, na

23、region on the exterior surface ofthe shell characterized by interconnecting subsurface pores,generally with volume porosity between 30 to 70 %, averagepore size between 100 to 1000 m, and a thickness between500 to 1500 m. This porous layer may be manufactureddirectly into the device by casting or by

24、 various electro/chemical/thermal/mechanical means, or applied as a coating ofparticles, beads, or mesh by processes such as sintering orplasma spray.3.1.6 radiographic marker, nnonstructural, generally thinwire, designed to be apparent on X-rays taken after placementof implants that otherwise would

25、 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 or theexterior surface of the bearing element that is intended to affixthe bearing element to the shell.3.1.8 shell, nmetal structure supporting the artic

26、ulatingsurface material, and which may be fixed rigidly to thearticulating surface or fixed such that it allows the articulatingsurface to rotate or translate.3.1.9 surface texturing, nrepetitive or random deviationsfrom the nominal surface that forms the three dimensionaltopography of the surface.3

27、.2 Dimensions of acetabular prostheses should be desig-nated in accordance with Figs. 1-3 or by an equally acceptableand detailed method.NOTE 1Figs. 1-3 are intended to be illustrative of typical acetabularprostheses and to designate dimensions, but representation of the compo-nents does not otherwi

28、se form part of the standard.4. Types4.1 Acetabular prostheses falling within the scope of thisspecification are of two types, as defined below. There are nodistinguishing features (for example, augmentation or lackthereof, holes, and so forth) that would exempt any device fromany requirement of thi

29、s 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,but not sufficient, assurance of function of t

30、he device madefrom them.All devices conforming to this specification shall befabricated from materials with adequate mechanical strengthand durability, corrosion resistance, and biocompatibility.5.1.1 Mechanical StrengthVarious components of ac-etabular prostheses have been successfully fabricated f

31、rom thefollowing materials: See Specifications F 67, F 75, F 90, F 136,F 138, F 562, F 563, F 603, F 648, F 745, F 799, F 1108,F 1185, F 1377, F 1472, F 1537, F 1580; and ISO 5832,ISO 5834, and ISO 6474. However, not all of these materialsmay possess sufficient mechanical strength for critical highl

32、ystressed components nor for articulating surfaces. Associatedstandards include Practices F 601 and F 629.5.1.2 Corrosion ResistanceMaterials with limited or nohistory of successful use for orthopaedic implant application4Available from International Organization for Standardization, 1 Rue deVaremb,

33、 Case Postale 56, CH-1211, Geneva 20, Switzerland.5Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700Robbins Ave, Philadelphia, PA 19111-5094, Attn: NPODS.F 2091 01 (2006)2must be determined to exhibit corrosion resistance equal to orbetter than one of the materials listed i

34、n 5.1.1 when tested inaccordance to Test Method F 746.5.1.3 BiocompatibilityMaterials with limited or no his-tory of successful 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 testedi

35、n accordance to Practices F 748 and F 981 for a givenapplication.Key:SD1 Diameter of spherical socket SR Retention element 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 di

36、ameter (when present) SP1 Fixation element width or diameterSC2 Apical cavity diameter (when present) SP2 Fixation element heightSW Minimum wall thickness SP3 Distance to fixation element from shell faceSG Surface texture or coating depthFIG. 1 Shell Cross SectionKey:BD1 Diameter of spherical socket

37、 BH1 Distance from bearing element faceBD2 Retentive or nonretentive entry diameter to domeBD3 Relief diameter (entry chamfer, if present, BH2 Distance from augmentation to domeneed not extend through the whole BI Inside depthcircumference) BR Retention element depthBD4 Effective spherical external

38、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 Minimum wall thickness BL1 Offset of b from center of BD4BF Flange thickness (when present)FIG. 2 Bearing Ele

39、ment Cross SectionF 2091 01 (2006)36. Performance Requirements6.1 Structural RequirementsAcetabular prostheses con-forming to this specification shall be capable of withstandingnormal static and dynamic loading in the physiological range.It shall also demonstrate wear rates substantially equivalent

40、toor less than sterile ultra-high-molecular-weight polyethylene(Specification F 648) with a cobalt chromium couple. See TestMethod F 1820 and Guide F 1714.6.2 Metal and Ceramic Coating or Surface TextureIntegrityThe coating shall be free of detrimental blisters,delaminations, contamination, or poorl

41、y defined coatingboundaries when viewed with no magnification. It shall not failby spalling, cracking, detrimental material loss, or detrimentaldegradation. The following test methods shall be used (ifapplicable): Test Methods F 1044, F 1147, F 1160, F 1501, andF 1978.NOTE 3In situations in which th

42、ese 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 andefficacy of an acetabular prosthesis. The failure modes may beaddressed through relevant physical

43、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. Testing may encompass somecombination of static and dynamic loading environments.6.3.1 Component Disass

44、ociationDevices 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 Method F 1820.6.3.2 Fixation FailureDevices have loosened at the inter-face with the bone or bone cem

45、ent. 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 excessive wear through the bearing elementresulting in particle debris (see Guide F 1714).7. Dimensi

46、ons7.1 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, it may beappropriately marked for radiographic evaluation. Radio-graphic markers have been used in

47、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 the device.8. Finish and Appearance8.1 Bearing Element FinishAcetabular prostheses con-forming to

48、this specification shall be finished in accordancewith Specification F 2033.8.2 In accordance with Practices F86 and F 983, itemsconforming to this specification shall be marked as follows inorder of priority where space permits: manufacturer, material,lot number, catalog number, and size. Additiona

49、l 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 flange diameter (when present)FIG. 3 Plan View of Oval/Eccentric Configuration of Bearing Element and S