ASTM F2068-2003 Standard Specification for Femoral Prostheses&8212 Metallic Implants《大腿股假体标准规范 金属植入物》.pdf

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1、Designation: F 2068 03Standard 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 (e) 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 sur

3、gical 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 Femora

5、l 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 co

6、vered 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 o

7、f multicom-ponent modular femoral hip prostheses are not covered by thisspecification.1.7 The values stated in SI units are to be regarded as thestandard.2. Referenced Documents2.1 ASTM Standards:F 67 Specification for Unalloyed Titanium for SurgicalImplant Applications (UNS R50250, UNS R 50400, UNS

8、R 50550, UNS R50700)2F 75 Specification for Cobalt-28Chromium-6MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)2F 86 Practice for Surface Preparation and Marking of Me-tallic Surgical Implants2F 90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for

9、Surgical Implant Applica-tions (UNS R30605)2F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra-Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)2F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplant

10、s (UNS S31673)2F 562 Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R 30035)2F 563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563)2F 620 Specificati

11、on for Alpha Plus Beta Titanium AlloyForgings for Surgical Implants2F 745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications2F 746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant Materials2F 748

12、Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices2F 799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)2F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect t

13、o Effect ofMaterials on Muscle and Bone2F 983 Practice for Permanent Marking of Orthopaedic Im-plant Components2F 1044 Test Method for Shear Testing of Calcium Phos-phate Coatings and Metallic Coatings2F 1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants (UNS R56

14、406)21This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved Sept. 10, 2003. Published October 2003. Originallyapproved in 2000. Last previous edit

15、ion approved in 2001 as F 2068 01e1.2Annual Book of ASTM Standards, Vol 13.01.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic Coatings2F 1440 Practice for Cycl

16、ic Fatigue Testing of MetallicStemmed Hip Arthroplasty Femoral Components WithoutTorsion2F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)2F 1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS

17、R31537,UNS R 31538, and UNS R31539)2F 1580 Specification for Titanium and Titanium-6Aluminum-4Vanadium Alloy Powders for Coatings ofSurgical Implants2F 1612 Practice for Cyclic Fatigue Testing of MetallicStemmed Hip Arthroplasty Femoral Components withTorsion2F 1636 Specification for Bores and Cones

18、 for ModularFemoral Heads3F 1814 Specification for Evaluating Modular Hip and KneeJoint Components2F 1854 Test Method for Stereological Evaluation of PorousCoatings on Medical Implants2F 1978 Test Method for Measuring Abrasion Resistance ofMetallic Thermal Spray Coatings by Using the TaberyAbraser22

19、.2 ISO Documents:ISO 5832-1:1997 Implants for SurgeryMetallicMaterialsPart 1: Wrought Stainless Steel4ISO 5832-3:1996 Implants for SurgeryMetallicMaterialsPart 3: Wrought Titanium 6-Aluminum4-Vanadium Alloy4ISO 5832-4:1996 Implants for SurgeryMetallicMaterialsPart 4: Cobalt-Chromium-Molybdenum Cast-

20、ing Alloy4ISO 5832-9:1992 Implants for SurgeryMetallicMaterialsPart 9: Wrought High Nitrogen StainlessSteel4ISO 7206-2:1996 Implants for SurgeryPartial and TotalHip Joint ProsthesesPart 2: Articulating Surfaces Madeof Metallic, Ceramic and Plastics materials4ISO 7206-4:1989 Implants for SurgeryParti

21、al and TotalHip Joint ProsthesesPart 4: Determination of EnduranceProperties of Stemmed Femoral Components with Appli-cation of Torsion4ISO 7206-8:1995 Implants for SurgeryPartial and TotalHip Joint ProsthesesPart 8: Endurance Performance ofStemmed Femoral Components with Application of Tor-sion4ISO

22、 7206-6:1992 Implants for SurgeryPartial and TotalHip Joint ProsthesesPart 6: Determination of EnduranceProperties of Head and Neck Region of Stemmed FemoralComponents43. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 bore, nan internal cavity, in the form of a truncatedright co

23、ne, 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 the implant that extendsdistally fro

24、m 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 member for articu-lation with the natu

25、ral 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) head, na femoral head that is notinte

26、gral 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) implant, na femoral hip compo-nent of

27、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) implant, na femoral hip com-pone

28、nt 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 attached to the head (Type I device

29、s) 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 size between 100 and 1000 m, and

30、a thickness between 500 and 1500 m (in accordance with TestMethod F 1854). This porous layer may be manufactureddirectly into the metallic implant by casting or by variouselectro/chemical/thermal/mechanical means, or applied as acoating of particles, beads, or mesh by processes such assintering or p

31、lasma spray.3.1.12 proximal body, nregion of the implant whichextends distally from the trochanteric region to the diaphysealregion 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 arthropl

32、asty, nreplacement of the naturalfemoral head with a prosthetic femoral head held in place by animplant extending into the shaft of the femur and replacementof the natural acetabulum with a prosthetic acetabulum. The3Discontinued; See 2000 Annual Book of ASTM Standards, Vol 13.01.4Available from Ame

33、rican National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.F2068032prosthetic 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 t

34、ypes as defined 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 prost

35、hesis with an 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 prosthes

36、es with anintegral stem, neck, and head. The stem is designed such thatthe center of the head, the axis of the neck, the proximal body,and the distal stem do not lie in the same medial/lateral plane.This would include anteverted necks, proximally curved stems,distally bowed stems, and so forth.4.1.3

37、 Type IIAModular 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 i

38、s designed such 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” design

39、s allow for 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. T

40、his would includeanteverted 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 ma

41、terials from which femoral hip prosthe-ses have been successfully fabricated include SpecificationsF 67, F 75, F 90, F 136, F 138, F 562, F 563, F 620, F 745,F 799, F 1108, F 1472, F 1537, and F 1580 and ISO Standards5832/1:1997/3:1996/4:1996/9:1992.5.1.1 Mechanical StrengthNot all of the materials

42、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. Manufacturing processes and

43、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 orthopedic implant applicationmust b

44、e 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 mustbe determined to exhibit accepta

45、ble 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 in Section 6, corrosion resista

46、nce 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 defo

47、rmation, or fatiguefracture.NOTE 1Consult the rationale in Appendix X2 for comments regardingthe application of 6.1.6.1.1 Fatigue performance of the femoral hip componentsmay be characterized by testing in accordance with ISO7206-4:1989, Practice F 1612, or Practice F 1440. Representa-tive samples s

48、hall be able to withstand cyclic loading with aminimum load of 300 N and a maximum load of 2.3 kN inaccordance with ISO 7206-8:1995 when tested in accordancewith ISO 7206-4:1989 or Practice F 1612, or cyclic loadingwith a minimum load of 300 N and a maximum load of 3.3 kNwhen tested in accordance wi

49、th Practice F 1440. For ASTMtest methods, use an unsupported implant length of 50 mm inaccordance with the ASTM definition. The representative testsamples should be selected from the standard (average patient)size range and which presents the worse case stress conditionsfor the design series. To meet the worse case stress recommen-dation, implants should be tested with the worst-case offsethead.6.1.2 Alternatively, the demonstrated fatigue strength of theimplant size with the highest stresses, when tested with theworst-case offset head and in acc