ASTM F2887-2012 Standard Specification for Total Elbow Prostheses《全肘关节假体的标准规范》.pdf

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1、Designation: F2887 12Standard Specification forTotal Elbow Prostheses1This standard is issued under the fixed designation F2887; 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 parentheses ind

2、icates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers total elbow replacement (TER)prostheses and hemi-elbow replacement (“hemi”) prosthesesused to provide functioning articulation by empl

3、oying humeral,ulnar, and/or radial components that allow for the restoration ofmotion of the human elbow joint complex.1.2 Included within the scope of this specification are elbowprosthesis components for primary and revision surgery withlinked and non-linked designs and components implanted withor

4、 without use of bone cement.1.3 This specification is intended to provide basic descrip-tions of material and prosthesis geometry. In addition, thosecharacteristics determined to be important to the in vivoperformance of the prosthesis are defined. However, compli-ance with this specification does n

5、ot itself mean that a devicethat will provide satisfactory clinical performance.1.4 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:2F75 Specification for Cobalt-28 Chromium-6 Molybdenum

6、Alloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F136 Specification for Wrought Tit

7、anium-6Aluminum-4Vanadium ELI (Extra Low Interstitial)Alloy for SurgicalImplant Applications (UNS R56401)F451 Specification for Acrylic Bone CementF565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabr

8、icated Form for Surgical Im-plantsF732 Test Method for Wear Testing of Polymeric MaterialsUsed in Total Joint ProsthesesF746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF799 Spec

9、ification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)F983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1044 Test Method for Shear Testing of Calcium PhosphateCoatings and Metallic CoatingsF1108 Specification for Titanium-6Alu

10、minum-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 Medical and Compos-ite Calcium Phosphate/Metallic CoatingsF1223 Te

11、st Method for Determination of Total Knee Re-placement ConstraintF1377 Specification for Cobalt-28Chromium-6MolybdenumPowder for Coating of Orthopedic Implants (UNSR30075)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)F1537 Specificati

12、on for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNSR31537, UNS R31538, and UNS R31539)F1580 Specification for Titanium and Titanium-6Aluminum-4 Vanadium Alloy Powders for Coatings ofSurgical ImplantsF1814 Guide for Evaluating Modular Hip and Knee JointComponentsF2759 Guide

13、 for Assessment of the Ultra High MolecularWeight Polyethylene (UHMWPE) Used in Orthopedic andSpinal Devices1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current ed

14、ition approved Dec. 15, 2012. Published March 2013. DOI: 10.1520/F288712.2For referenced ASTM standards, 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 A

15、STM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.2 ISO Standards:3ISO 58323 Implants for SurgeryMetallic MaterialsPart 3: Wrought Titanium 6-Aluminum 4-Vandium AlloyISO 58324 Implants for SurgeryMetallic MaterialsPart 4:

16、Cobalt-Chromium-Molybdenum Casting AlloyISO 583212 Implants for SurgeryMetallic MaterialsPart 12: Wrought Cobalt-Chromium-Molybdenum AlloyISO 58342 Implants for SurgeryUltra High MolecularWeight PolyethylenePart 2: Moulded FormsISO 6018 Orthopaedic ImplantsGeneral Requirements forMarking, Packaging,

17、 and LabelingISO 10993 Biological Evaluation of Medical DevicesPartI: Evaluation and Testing Within a Risk ManagementProcessISO 142431 Implants for SurgeryWear of Total Knee-Joint ProsthesesPart 1: Loading and Displacement Pa-rameters for Wear-testing Machines with Load Controland Corresponding Envi

18、ronmental Conditions for TestISO 142432 Implants for SurgeryWear of Total Knee-joint ProsthesesPart 2: Methods of MeasurementISO 142433 Implants for SurgeryWear of Total Knee-joint ProsthesesPart 3: Loading and Displacement Pa-rameters for Wear-testing Machines with DisplacementControl and Correspon

19、ding Environmental Conditions forTest2.3 FDA Documents:421 CFR 888.3150 Elbow Joint Metal/Polymer ConstrainedCemented Prosthesis21 CFR 888.3160 Elbow Joint Metal/Polymer Semi-constrained Cemented Prosthesis21 CFR 888.3170 Elbow Joint Radial (Hemi-elbow) Poly-mer Prosthesis21 CFR 888.3180 Elbow Joint

20、 Humeral (Hemi-elbow) Me-tallic Uncemented Prosthesis21 CFR 888.6 Degree of ConstraintGuidance Document for Testing Orthopedic Implants withModified Metallic Surfaces Apposing Bone or BoneCementGuidance for Industry on the Testing of Metallic PlasmaSprayed Coatings on Orthopedic Implants to SupportR

21、econsideration of Postmarket Surveillance RequirementsGuidance Document for Testing Non-articulating, Mechani-cally Locked Modular Implant ComponentsClass II Special Controls Guidance Document: Knee JointPatellofemorotibial and Femorotibial Metal/PolymerPorous-Coated Uncemented Prostheses; Guidance

22、for In-dustry and FDA2.4 ANSI/ASME Standard:3ANSI/ASME B46.11995 Surface Texture (SurfaceRoughness, Waviness, and Lay)3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 bearing surface, npart of the prosthetic componentthat articulates against the counter surface of the natural o

23、rprosthetic elbow joint.3.1.2 extension, nrotation of the ulna and radius awayfrom the humerus around the elbow joint axis in the sagittalplane.3.1.3 flexion, nrotation of the ulna and radius towards thehumerus around the elbow joint axis in the sagittal plane.3.1.4 hemi-elbow replacement (hemi), np

24、rosthetic partthat substitutes for the natural humero-ulnar, radio-ulnar and/orhumero-radial articulating surfaces in the human elbow inwhich only one half of the articulating surfaces is replaced. Theprosthesis is expected to articulate with the remaining naturalbiological surface(s).3.1.5 humeral

25、component, ncomponent fixed to the hu-merus for articulation with the natural or prosthetic ulnarand/or radial component(s), typically consisting of two majorcomponents: a fixation stem, and a bearing surface.3.1.6 interlock, nmechanical design feature used to in-crease the capture of one component

26、within another to restrictunwanted displacement between components (that is, lockingmechanism for modular components such as a bearing surfaceto a metallic stem component).3.1.7 laxity, nintentional looseness in the fit betweenlinked style elbow prosthetic components (typically thehumero-ulnar compo

27、nents) that allows small, secondary out-of-plane motions during primary motion to avoid a “fullyconstrained” or “rigid” connection.3.1.8 linked, na style of total elbow prosthesis in whichthe humeral and ulnar components are physically connected bya linking mechanism to prevent disassociation (dislo

28、cation)while allowing motion in selected directions.3.1.9 non-linked, na style of total elbow prosthesis inwhich the humeral and ulnar components are not physicallyconnected by a linking mechanism. These components rely onsoft tissue or another mechanism to minimize the potential fordisassociation (

29、dislocation) of the two components.3.1.10 pronation, nrotation of the radius medially aboutthe ulna around a superior-inferior axis.3.1.11 radial component, ncomponent fixed to the radiusfor articulation with the natural or prosthetic humeral and/orulnar component(s), typically consisting of two maj

30、or compo-nents: a fixation stem and a bearing surface.3.1.12 subluxation, ninstability or partial dislocationwhich occur when the relative translational or rotationalmotion between the humeral and ulnar components reaches anextreme where the two components would cease to articulateover the designate

31、d low-friction bearing surfaces.3.1.13 supination, nrotation of the radius laterally aboutthe ulna around a superior-inferior axis.3.1.14 total elbow replacement (TER), nprosthetic partsthat substitute for, at a minimum, the natural opposing humeraland ulnar articulating surfaces in the human elbow.

32、 Thisincludes both humero-ulnar type devices that are intended to3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.4Available from Food and Drug Administration (FDA), 10903 New HampshireAve., Silver Spring, MD 20993-0002, h

33、ttp:/www.fda.gov.F2887 122function with or without the natural radial head and humero-ulnar with humero-radial option type devices that are intendedto replace all three natural articular surfaces of the elbow.3.1.15 ulnar component, ncomponent fixed to the ulna forarticulation with the natural or pr

34、osthetic humeral and/or radialcomponent(s), typically consisting of two major components: afixation stem and a bearing surface.3.1.16 valgus, ndeviation of the ulna away from themidline of the body in the frontal plane.3.1.17 varus, ndeviation of the ulna towards the midlineof the body in the fronta

35、l plane.4. Classification4.1 The following classification by degree of constraint issuggested for all total joint prostheses including total elbowreplacement systems based on the concepts adopted by the U.S.Food and Drug Administration (see 2.3).4.1.1 ConstrainedA “constrained” joint prosthesis is u

36、sedfor joint replacement and prevents dislocation of the prosthesisin more than one anatomic plane and consists of either a single,flexible, across-the-joint component or more than one compo-nent linked together or affined.4.1.2 Semi-constrainedA “semi-constrained” joint pros-thesis is used for join

37、t replacement and limits translation androtation of the prosthesis in one or more planes via thegeometry of its articulating surfaces. It has no across-the-jointlinkage.4.1.3 Currently, most TERs are considered either semi-constrained or constrained. However, devices within a particu-lar classificat

38、ion may allow varying degrees of freedom (that istranslation, rotation, and so forth). Currently, TERs whichcontain a linkage mechanism are classified as “constrained” per4.1.1 yet these devices are often referred to as “sloppy hinge”or “linked, semi-constrained” in the peer-reviewed literature inre

39、ference to the laxity built into the linkage mechanism toprevent a completely constrained (rigid) connection. Thesetypes of devices allow some amount of varus/valgus and rotarymotion between the humeral and ulnar components in additionto the primary flexion/extension motion. Devices without thisaddi

40、tional laxity are often referred to as “fully constrained” inthe literature. See X2.4 for additional discussion.5. Material5.1 The choice of materials is understood to be a necessarybut not sufficient assurance of function of the device madefrom them.All devices conforming to this specification shal

41、l befabricated from materials with adequate mechanical strength,durability, corrosion resistance, biocompatibility, and wearresistance.5.1.1 Mechanical StrengthVarious metallic componentsof elbow replacement devices have been successfully fabri-cated from materials, as examples, found in ASTM Specif

42、ica-tions F75, F90, F136, F799, F1108, F1377, F1472, and F1537and ISO 58323. Polymeric bearing components have beenfabricated from ultra high molecular weight polyethylene(UHMWPE) as an example, as specified in Specification F648,Guide F2759, or ISO 58342. Porous coatings have beenfabricated from ex

43、ample materials specified in SpecificationsF75, F136, F1377, and F1580. Not all of these materials maypossess sufficient mechanical strength for critical, highlystressed components or for articulating surfaces. Confor-mances of a selected material to its standard and successfulclinical usage of the

44、material in a previous implant design arenot sufficient to ensure the strength of an implant. Manufac-turing processes and implant design can strongly influencematerial properties and performance. Therefore, regardless ofthe material selected, the elbow prosthesis shall meet theperformance requireme

45、nts of Section 6 of this specification.5.1.2 Corrosion ResistanceMaterials with 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 with Test

46、 Method F746. If the corrosion resistanceof a material is less than one of the materials listed in 5.1.1when tested in accordance to Test Method F746, its use shall bejustified.5.1.3 BiocompatibilityThe biocompatibility of materialsused shall be evaluated using a risk based approach such as thatoutl

47、ined in ISO 109931. Practice F748 or ISO 10993 provideguidance on types of biologic tests to perform on materials.5.1.4 Friction CharacteristicsBearing surface materialcouples with limited or no history of successful use fororthopaedic implant application shall be determined to exhibitequal or bette

48、r performance than one of the material coupleslisted in 5.1.1 when tested in a pin-on-flat or pin-on-disk testapparatus such as described in Test Method F732 with ad-equate controls for comparison. A number of different loadlevels may be used to cover the range of anticipated stressesbetween articul

49、ating components.NOTE 1Clinically successful elbow prostheses have utilized eitherCoCrMo alloy or Ti alloy articulating against UHMWPE. The wearbehavior of Ti alloy articulating against UHMWPE in the presence of athird body (for example, bone or bone cement particles) has beendemonstrated to be less than that of CoCrMo alloy articulating againstUHMWPE under similar conditions. Therefore, appropriate surface treat-ments of the Ti alloy surface should be considered to improve wearperformance of a Ti alloy/UHMWPE bearing couple in the