ASTM F2068-2009 Standard Specification for Femoral Prostheses&8212 Metallic Implants《股骨假体标准规范&8212 金属植入物》.pdf

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1、Designation: F 2068 09Standard Specification forFemoral ProsthesesMetallic Implants1This standard is issued under the fixed designation F 2068; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in

2、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 metallic stemmed femoralprostheses used to replace the natural hip joint by means ofhemi-arthroplasty or total hip surg

3、ical procedures. Prosthesesfor hemi-arthroplasty are intended to articulate with the naturalacetabulum of the patient. Prostheses for total hip replacementare intended to articulate with prosthetic acetabular cups.Prostheses may have integral femoral heads or cones designedto accept modular heads.1.

4、2 Modular femoral heads, which may be affixed to coneson implants covered by this specification, are not covered bythis specification. The mechanical strength, corrosion resis-tance, and biocompatibility of the head portions of one-pieceintegral implants are covered by this specification.1.3 Femoral

5、 prostheses included within the scope of thisspecification are intended for fixation by press fit between theprosthesis and host bone, the use of bone cement, or throughthe ingrowth of host bone into a porous coating.1.4 Custom femoral prostheses, designed explicitly for asingle patient, are not cov

6、ered within the scope of thisspecification.1.5 Prostheses incorporating nonmetallic (for example,polymer composite) implants, nonporous bioactive ceramiccoatings, or porous-polymer coatings, are specifically excludedfrom the scope of this specification.1.6 The requirements for modular connections of

7、 multicom-ponent modular femoral hip prostheses are not covered by thisspecification.1.7 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.2. Referenced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed Titanium, for Su

8、rgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, 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 Wrough

9、t Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical 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

10、Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)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 Impl

11、ant Applications (UNS R30563)3F 620 Specification for Alpha Plus Beta Titanium AlloyForgings for Surgical ImplantsF 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

12、 ofMetallic Surgical Implant MaterialsF 748 Practice for Selecting Generic Biological Test Meth-ods 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-te

13、rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF 983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF 1044 Test Method for Shear Testing of Calcium Phos-phate Coatings and Metallic Coatings1This specification is under the jurisdiction of ASTM Commi

14、ttee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved Sept. 1, 2009. Published September 2009. Originallyapproved in 2000. Last previous edition approved in 2003 as F 2068 03.2For referenced ASTM standard

15、s, 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.3Withdrawn. The last approved version of this historical standard is referencedon www.astm

16、.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants (UNS R56406)F 1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic Coat

17、ingsF 1440 Practice for Cyclic Fatigue Testing of MetallicStemmed Hip Arthroplasty Femoral Components WithoutTorsionF 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)F 1537 Specification for Wrought Cobalt-28Chromium-6MolybdenumAlloys fo

18、r Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)F 1580 Specification for Titanium and Titanium-6Aluminum-4 Vanadium Alloy Powders for Coatings ofSurgical ImplantsF 1586 Specification for Wrought Nitrogen Strengthened21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar for S

19、urgicalImplants (UNS S31675)F 1612 Practice for Cyclic Fatigue Testing of MetallicStemmed Hip Arthroplasty Femoral Components withTorsionF 1636 Specification for Bores and Cones for ModularFemoral Heads3F 1813 Specification for Wrought Titanium12 Molybde-num6 Zirconium2 IronAlloy for Surgical Implan

20、t (UNSR58120)F 1814 Guide for Evaluating Modular Hip and Knee JointComponentsF 1854 Test Method for Stereological Evaluation of PorousCoatings on Medical ImplantsF 1978 Test Method for Measuring Abrasion Resistance ofMetallic Thermal Spray Coatings by Using the TaberAbraser2.2 ISO Documents:4ISO 583

21、2-1:1997 Implants for SurgeryMetallicMaterialsPart 1: Wrought Stainless SteelISO 5832-3:1996 Implants for SurgeryMetallicMaterialsPart 3: Wrought Titanium 6-Aluminum4-Vanadium AlloyISO 5832-4:1996 Implants for SurgeryMetallicMaterialsPart 4: Cobalt-Chromium-Molybdenum Cast-ing AlloyISO 5832-9:1992 I

22、mplants for SurgeryMetallicMaterialsPart 9: Wrought High Nitrogen Stainless SteelISO 5832-12:2007 Implants for SurgeryMetallicMaterialsPart 12: Wrought Cobalt-Chromium-Molybdenum AlloyISO 5832-12:2007/Cor 1: 2008 Implants for SurgeryMetallic MaterialsPart 12: Wrought Cobalt-Chromium-Molybdenum Alloy

23、, Technical Corrigendum 1ISO 5832-14:2007 Implants for SurgeryMetallicMaterialsPart 14: Wrought Titanium 15-Molybdenum5-Zirconium 3-Aluminum AlloyISO 7206-2:1996 Implants for SurgeryPartial and TotalHip Joint ProsthesesPart 2: Articulating Surfaces Madeof Metallic, Ceramic and Plastics materialsISO

24、7206-4:1989 Implants for SurgeryPartial and TotalHip Joint ProsthesesPart 4: Determination of EnduranceProperties of Stemmed Femoral Components with Appli-cation of TorsionISO 7206-8:1995 Implants for SurgeryPartial and TotalHip Joint ProsthesesPart 8: Endurance Performance ofStemmed Femoral Compone

25、nts with Application of Tor-sionISO 7206-6:1992 Implants for SurgeryPartial and TotalHip Joint ProsthesesPart 6: Determination of EnduranceProperties of Head and Neck Region of Stemmed FemoralComponents3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 bore, nan internal cavity,

26、in the form of a truncatedright cone, used to engage with the cone of a femoral neck.3.1.2 collar, nflange at the junction of the neck andproximal body.3.1.3 cone, nthe truncated conic geometry on a femoralhip prosthesis used to engage with the bore of a femoral head.3.1.4 distal stem, nregion of th

27、e implant that extendsdistally from the proximal body. This part of the implant isintended for insertion within the femoral medullary canal. Thedistal stem may be in direct apposition with bone or may befixed in the femoral medullary canal using bone cement.3.1.5 head, nconvex spherical bearing memb

28、er for articu-lation with the natural acetabulum or prosthetic acetabulum.3.1.6 hemi-arthroplasty, nreplacement of the naturalfemoral head with a prosthetic femoral head held in place by animplant extending into the shaft of the femur. The naturalacetabulum is not altered.3.1.7 modular (Type II) hea

29、d, na femoral head that is notintegral with the neck and proximal body. It is a convexbearing member for articulation with either natural acetabulumor the prosthetic acetabulum. It possesses an integrally ma-chined bore for fitting the cone of a modular (Type II) implant.3.1.8 modular (Type II) impl

30、ant, na femoral hip compo-nent in which the head is not integral with the neck andproximal body of the implant. The modular implant is intendedfor insertion within the femoral medullary canal. It possesses acone that provides a stable connection for the modular (TypeII) head.3.1.9 mono-block (Type I

31、) implant, na femoral hip com-ponent in which the head is integral with the neck and proximalbody of the implant.3.1.10 neck, nthe portion of the femoral prosthesis con-necting the proximal body and the prosthetic femoral head.Theneck is integral with the proximal body, and is either perma-nently at

32、tached to the head (Type I devices) or to a conedesigned to accept a modular head (Type II devices).3.1.11 porous surface, nan outermost layer(s) of all orpart of the femoral implant characterized by interconnectingsubsurface pores, generally with the volume porosity between30 and 70 %, average pore

33、 size between 100 and 1000 m, anda thickness between 500 and 1500 m (in accordance with Test4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.F2068092Method F 1854). This porous layer may be manufactureddirectly into the me

34、tallic implant by casting or by variouselectro/chemical/thermal/mechanical means, or applied as acoating of particles, beads, or mesh by processes such assintering or plasma spray.3.1.12 proximal body, nregion of the implant whichextends distally from the trochanteric region to the diaphysealregion

35、of the femur. This portion of the implant may be indirect apposition with bone or may be fixed in the femoralmedullary canal using bone cement.3.1.13 total hip arthroplasty, nreplacement of the naturalfemoral head with a prosthetic femoral head held in place by animplant extending into the shaft of

36、the femur and replacementof the natural acetabulum with a prosthetic acetabulum. Theprosthetic femoral head articulates with the bearing surface ofthe prosthetic acetabulum.4. Classification of Implant Type4.1 Femoral prostheses falling within the scope of thisspecification are of four types as defi

37、ned as follows. There areno distinguishing features (for example, collars or lack thereof,fenestrations, and so forth) that would exempt any device fromany requirement of this specification.4.1.1 Type IASingle-piece (mono-block), metallic femo-ral total hip or hemi-arthroplasty hip prosthesis with a

38、n integralstem, neck and head. The stem is designed such that the centerof the head, the axis of the neck, and proximal body, and thedistal stem all lie in the same medial/lateral plane.4.1.2 Type IBSingle-piece (mono-block), metallic, femo-ral total hip or hemi-arthroplasty hip prosthesis with an i

39、ntegralstem, neck, and head. The stem is designed such that the centerof the head, the axis of the neck, the proximal body, and thedistal stem do not lie in the same medial/lateral plane. Thiswould include anteverted necks, proximally curved stems,distally bowed stems, and so forth.4.1.3 Type IIAMod

40、ular metallic femoral hip prosthesesthat could include a modular (Type II) head or other modularcomponents, or both. Such “modular” designs allow for moreflexible inventory management and provide a means foradjusting prosthesis neck length and, therefore, leg length atsurgery. The stem is designed s

41、uch that the center of the head,the axis of the neck, the proximal body, and the distal stem alllie in the same medial/lateral plane.4.1.4 Type IIBModular metallic femoral hip prosthesisthat could include a modular (Type II) head or other modularcomponents, or both. Such “modular” designs allow for

42、moreflexible inventory management and provide a means foradjusting prosthesis neck length and, therefore, leg length atsurgery. The stem is designed such that the center of the head,the axis of the neck, the proximal body, and the distal stem donot lie in the same medial/lateral plane. This would in

43、cludeanteverted necks, proximally curved stems, distally bowedstems, and so forth.5. Materials5.1 All devices conforming to this specification shall befabricated from materials with adequate mechanical strengthand durability, corrosion resistance, and biocompatibility.Some examples of materials from

44、 which femoral hip prosthe-ses have been successfully fabricated include SpecificationsF67, F75, F90, F 136, F 138, F 562, F 563, F 620, F 745,F 799, F 1108, F 1472, F 1537, F 1580, F 1586, and F 1813,and ISO Standards 5832/1:1997/3:1996/4:1996/9:1992/12:2007/Cor 1:2008/14:2007.5.1.1 Mechanical Stre

45、ngthNot all of the materials listedin 5.1 possess sufficient mechanical strength for critical highlystressed components. Conformance of a selected material to itsstandard and successful clinical usage of the material in aprevious implant design are not sufficient to ensure the strengthof an implant.

46、 Manufacturing processes and implant design canstrongly influence material properties. Therefore, regardless ofthe material selected, the femoral hip implant must meet theperformance requirements of Section 6.5.1.2 Corrosion ResistanceMaterials with limited or nohistory of successful use for orthope

47、dic implant applicationmust be determined to exhibit corrosion resistance equal to orbetter than one of the materials listed in 5.1 when tested inaccordance with Test Method F 746.5.1.3 BiocompatibilityMaterials with limited or no his-tory of successful use for orthopedic implant application shallbe

48、 determined to exhibit acceptable biological response equalto or better than one of the materials listed in 5.1 when testedin accordance with Practices F 748 and F 981.5.1.4 The selection, strength, and processing of implantmaterials shall be consistent with the performance require-ments contained i

49、n Section 6, corrosion resistance of 5.1.2, andthe biocompatilibity requirements of 5.1.3.6. Performance Considerations6.1 Structural RequirementsFemoral prostheses conform-ing to this specification shall be capable of withstandingnormal static and dynamic loading in the physiological rangewithout overload fracture, plastic deformation, or fatiguefracture.NOTE 1Consult the rationale inAppendix X2 for comments regardingthe application of 6.1.6.1.1 Fatigue performance of the femoral hip componentsmay be characterized by testing in a