ASTM F2068-2015 Standard Specification for Femoral ProsthesesMetallic Implants《股骨假体金属植入物的标准规格》.pdf

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1、Designation: F2068 09F2068 15Standard Specification forFemoral ProsthesesMetallic Implants1This standard is issued under the fixed designation F2068; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A numb

2、er 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 metallic stemmed femoral prostheses used to replace the natural hip joint by means ofhemi-arthroplasty or total h

3、ip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the naturalacetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prosthesesmay have integral femoral heads or cones designed to accept modula

4、r heads.1.2 Modular femoral heads, which may be affixed to cones on implants covered by this specification, are not covered by thisspecification. The mechanical strength, corrosion resistance, and biocompatibility of the head portions of one-piece integralimplants are covered by this specification.1

5、.3 Femoral prostheses included within the scope of this specification are intended for fixation by press fit between theprosthesis and host bone, the use of bone cement, or through the ingrowth of host bone into a porous coating.1.4 Custom femoral prostheses, designed explicitly for a single patient

6、, are not covered within the scope of this specification.1.5 Prostheses incorporating nonmetallic (for example, polymer composite) implants, nonporous bioactive ceramic coatings, orporous-polymer coatings, are specifically excluded from the scope of this specification.1.6 The requirements for modula

7、r connections of multicomponent modular femoral hip prostheses are not covered by thisspecification.1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.2. Referenced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed

8、 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 Surgical Implants (UNSR30075)F86 Practice for Surface Preparation and Marking of Metallic Surgical ImplantsF90 Specif

9、ication for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNSR30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-

10、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(UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for

11、Surgical ImplantApplications (UNS R30563) (Withdrawn 2005)3F620 Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct respons

12、ibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Sept. 1, 2009March 15, 2015. Published September 2009May 2015. Originally approved in 2000. Last previous edition approved in 20032009as F2068 03.F2068 09. DOI: 10.1520/F2068-09.10.1520/F2068-15.2 For referencedASTM standards, vi

13、sit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards 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 States1F745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed SurgicalImplant Applications (Withdra

16、wn 2012)3F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methods for Materials and DevicesF799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,R31539)F

17、981 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 of Calcium Phosphate Coatings and Metallic CoatingsF1108 Sp

18、ecification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic CoatingsF1440 Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion(Withdrawn 20

19、12)3F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNSR31538, and UNS R31539)F1580 Specification for Titanium and Titanium-6 Alumi

20、num-4 Vanadium Alloy Powders for Coatings of Surgical ImplantsF1586 Specification for Wrought Nitrogen Strengthened 21Chromium10Nickel3Manganese2.5Molybdenum StainlessSteel Alloy Bar for Surgical Implants (UNS S31675)F1612 Practice for Cyclic FatigueTesting of Metallic Stemmed HipArthroplasty Femora

21、l Components withTorsion (Withdrawn2011)3F1636 Specification for Bores and Cones for Modular Femoral Heads (Withdrawn 2001)3F1813 Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)F1814 Guide for Evaluating Modular Hip and Knee Joint ComponentsF1

22、854 Test Method for Stereological Evaluation of Porous Coatings on Medical ImplantsF1978 Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber AbraserF2996 Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems2.

23、2 ISO Documents:3ISO 5832-1:19975832-1:2007/Cor 1:2008 Implants for SurgeryMetallic MaterialsPart 1: Wrought Stainless SteelISO 5832-3:1996 Implants for SurgeryMetallic MaterialsPart 3: Wrought Titanium 6-Aluminum 4-Vanadium AlloyISO 5832-4:1996 Implants for SurgeryMetallic MaterialsPart 4: Cobalt-C

24、hromium-Molybdenum Casting AlloyISO 5832-9:19925832-9:2007 Implants for SurgeryMetallic MaterialsPart 9: Wrought High Nitrogen Stainless SteelISO 5832-12:2007 Implants for SurgeryMetallic MaterialsPart 12: Wrought Cobalt-Chromium-Molybdenum AlloyISO 5832-12:2007/Cor 1: 20081:2008 Implants for Surger

25、yMetallic MaterialsPart 12: Wrought Cobalt-Chromium-Molybdenum Alloy, Technical Corrigendum 1ISO 5832-14:2007 Implants for SurgeryMetallic MaterialsPart 14: Wrought Titanium 15-Molybdenum 5-Zirconium3-Aluminum AlloyISO 7206-2:19967206-2:2011 Implants for SurgeryPartial andTotal Hip Joint ProsthesesP

26、art 2:Articulating Surfaces Madeof Metallic, Ceramic and Plastics materialsISO 7206-4:19897206-4:2010 Implants for SurgeryPartial and Total Hip Joint ProsthesesPart 4: Determination ofEndurance Properties and Performance of Stemmed Femoral Components with Application of TorsionISO 7206-7 Implants fo

27、r SurgeryPartial and Total Hip Join ProsthesesPart 7: Endurance Performance of Stemmed FemoralComponents without Application of Torsion (withdrawn)ISO 7206-8:1995 Implants for SurgeryPartial and Total Hip Joint ProsthesesPart 8: Endurance Performance of StemmedFemoral Components with Application of

28、Torsion (withdrawn)ISO 7206-6:19927206-6:2013 Implants for SurgeryPartial and Total Hip Joint ProsthesesPart 6: Determination ofEndurance Properties of Head and Testing and Performance Requirements of Neck Region of Stemmed Femoral Components3. Terminology3.1 Definitions of Terms Specific to This St

29、andard:3.1.1 bore, nan internal cavity, in the form of a truncated right cone, used to engage with the cone of a femoral neck.3.1.2 collar, nflange at the junction of the neck and proximal body.3.1.3 cone, nthe truncated conic geometry on a femoral hip prosthesis used to engage with the bore of a fe

30、moral head.3 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.F2068 1523.1.4 distal stem, nregion of the implant that extends distally from the proximal body. This part of the implant is intended forinsertion within the fe

31、moral medullary canal. The distal stem may be in direct apposition with bone or may be fixed in the femoralmedullary canal using bone cement.3.1.5 head, nconvex spherical bearing member for articulation with the natural acetabulum or prosthetic acetabulum.3.1.6 hemi-arthroplasty, nreplacement of the

32、 natural femoral head with a prosthetic femoral head held in place by an implantextending into the shaft of the femur. The natural acetabulum is not altered.3.1.7 modular (Type II) head, na femoral head that is not integral with the neck and proximal body. It is a convex bearingmember for articulati

33、on with either a natural acetabulum or the prosthetic acetabulum. It possesses an integrally machined borefor fitting the cone of a modular (Type II) implant.3.1.8 modular (Type II) implant, na femoral hip component in which the head is not integral with the neck and proximal bodyof the implant. The

34、 modular implant is intended for insertion within the femoral medullary canal. It possesses a cone that providesa stable connection for the modular (Type II) head.3.1.9 mono-block (Type I) implant, na femoral hip component in which the head is integral with the neck and proximal bodyof the implant.3

35、.1.10 neck, nthe portion of the femoral prosthesis connecting the proximal body and the prosthetic femoral head. The neckis integral with the proximal body, and is either permanently attached to the head (Type I devices) or to a cone designed to accepta modular head (Type II devices).3.1.11 porous s

36、urface, nan outermost layer(s) of all or part of the femoral implant characterized by interconnecting subsurfacepores, generally with the volume porosity between 30 and 70 %, average pore size between 100 and 1000 m, and a thicknessbetween 500 and 1500 m (in accordance with Test Method F1854). This

37、porous layer may be manufactured directly into themetallic implant 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.3.1.12 proximal body, nregion of the implant which extends distall

38、y from the trochanteric region to the diaphyseal region ofthe femur. This portion of the implant may be in direct apposition with bone or may be fixed in the femoral medullary canal usingbone cement.3.1.13 total hip arthroplasty, nreplacement of the natural femoral head with a prosthetic femoral hea

39、d held in place by animplant extending into the shaft of the femur and replacement of the natural acetabulum with a prosthetic acetabulum. Theprosthetic femoral head articulates with the bearing surface of the prosthetic acetabulum.4. Classification of Implant Type4.1 Femoral prostheses falling with

40、in the scope of this specification are of four types as defined as follows. There are nodistinguishing features (for example, collars or lack thereof, fenestrations, and so forth) that would exempt any device from anyrequirement of this specification.4.1.1 Type IASingle-piece (mono-block), metallic

41、femoral total hip or hemi-arthroplasty hip prosthesis with an integral stem,neck and head. The stem is designed such that the center of the head, the axis of the neck, and the proximal body, and the distalstem all lie in the same medial/lateral plane.4.1.2 Type IBSingle-piece (mono-block), metallic,

42、 femoral total hip or hemi-arthroplasty hip prosthesis with an integral stem,neck, and head. The stem is designed such that the center of the head, the axis of the neck, the proximal body, and the distal stemdo not lie in the same medial/lateral plane. This would include anteverted necks, proximally

43、 curved stems, distally bowed stems,and so forth.4.1.3 Type IIAModular metallic femoral hip prostheses that could include a modular (Type II) head or other modularcomponents, or both. Such “modular” designs allow for more flexible inventory management and provide a means for adjustingprosthesis neck

44、 length and, therefore, leg length at surgery. The stem is designed such that the center of the head, the axis of theneck, the proximal body, and the distal stem all lie in the same medial/lateral plane.4.1.4 Type IIBModular metallic femoral hip prosthesis that could include a modular (Type II) head

45、 or other modularcomponents, or both. Such “modular” designs allow for more flexible inventory management and provide a means for adjustingprosthesis neck length and, therefore, leg length at surgery. The stem is designed such that the center of the head, the axis of theneck, the proximal body, and

46、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.5. Materials5.1 All devices conforming to this specification shall be fabricated from materials with adequate mechanical strength anddurability

47、, corrosion resistance, and biocompatibility. Some examples of materials from which femoral hip prostheses have beensuccessfully fabricated include Specifications F67, F75, F90, F136, F138, F562, F563, F620, F745, F799, F1108, F1472, F1537,F1580, F1586, and F1813, and ISO Standards 5832/1:1997/3:199

48、6/4:1996/9:1992/12:2007/Cor 1:2008/14:2007.F2068 1535.1.1 Mechanical StrengthNot all of the materials listed in 5.1 possess sufficient mechanical strength for critical highlystressed components. Conformance of a selected material to its standard and successful clinical usage of the material in a pre

49、viousimplant design are not sufficient to ensure the strength of an implant. Manufacturing processes and implant design can stronglyinfluence material properties. Therefore, regardless of the material selected, the femoral hip implant mustshall meet theperformance requirements of Section 6. Performance Considerations.5.1.2 Corrosion ResistanceMaterials with limited or no history of successful use for orthopedic implant application mustshallbe determined to exhibit corrosion resistance equal to or better than one of the materi