ASTM F2887-2017 Standard Specification for Total Elbow Prostheses《总肘部假肢的标准规格》.pdf

1、Designation: F2887 12F2887 17Standard 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 parenth

2、eses indicates 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”) prostheses usedto provide functioning articulatio

3、n by employing humeral, ulnar, and/or radial components that allow for the restoration of motionof the human elbow joint complex.1.2 Included within the scope of this specification are elbow prosthesis components for primary and revision surgery with linkedand non-linked designs and components impla

4、nted with or without use of bone cement.1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, thosecharacteristics determined to be important to the in vivo performance of the prosthesis are defined. However, compliance with thisspecificat

5、ion does not itself mean that a device that will provide satisfactory clinical performance.1.4 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:2F75 Specification for Cobalt-28 Chromium

6、-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNSR30075)F86 Practice for Surface Preparation and Marking of Metallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNSR30605)F136 Specification for

7、Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)F451 Specification for Acrylic Bone CementF565 Practice for Care and Handling of Orthopedic Implants and InstrumentsF648 Specification for Ultra-High-Molecular-Weight Polyethylene Pow

8、der and Fabricated Form for Surgical ImplantsF732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint ProsthesesF746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methods for Materials and De

9、vicesF799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,R31539)F983 Practice for Permanent Marking of Orthopaedic Implant ComponentsF1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsF1108 Specification fo

10、r Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic CoatingsF1160 Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite CalciumPhosphate/Metallic Co

11、atingsF1223 Test Method for Determination of Total Knee Replacement ConstraintF1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)1

12、 This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Dec. 15, 2012Jan. 1, 2017. Published March 2013March 2017. Originally approved in 2012. Last

13、 previous edition approved in 2012 as F2887-12.DOI: 10.1520/F288712.10.1520/F288717.2 For referencedASTM standards, visit 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 pa

14、ge on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard 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

15、users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1F1537 Specification for W

16、rought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNSR31538, and UNS R31539)F1580 Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical ImplantsF1814 Guide for Evaluating Modular Hip and Knee Joint ComponentsF2759 Guide for

17、Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and SpinalDevices2.2 ISO Standards:3ISO 58323 Implants for SurgeryMetallic MaterialsPart 3: Wrought Titanium 6-Aluminum 4-Vandium AlloyISO 58324 Implants for SurgeryMetallic MaterialsPart 4: Cobalt-Chromium-Molybd

18、enum Casting AlloyISO 583212 Implants for SurgeryMetallic MaterialsPart 12: Wrought Cobalt-Chromium-Molybdenum AlloyISO 58342 Implants for SurgeryUltra High Molecular Weight PolyethylenePart 2: Moulded FormsISO 6018 Orthopaedic ImplantsGeneral Requirements for Marking, Packaging, and LabelingISO 109

19、93109931 Biological Evaluation of Medical DevicesPart I:1: Evaluation and Testing Within a Risk ManagementProcessISO 142431 Implants for SurgeryWear of Total Knee-Joint ProsthesesPart 1: Loading and Displacement Parameters forWear-testing Machines with Load Control and Corresponding Environmental Co

20、nditions 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 Parameters forWear-testing Machines with Displacement Control and Corresponding Environm

21、ental Conditions for Test2.3 FDA Documents:421 CFR 888.3150 Elbow Joint Metal/Polymer Constrained Cemented Prosthesis21 CFR 888.3160 Elbow Joint Metal/Polymer Semi-constrained Cemented Prosthesis21 CFR 888.3170 Elbow Joint Radial (Hemi-elbow) Polymer Prosthesis21 CFR 888.3180 Elbow Joint Humeral (He

22、mi-elbow) Metallic Uncemented Prosthesis21 CFR 888.6 Degree of ConstraintGuidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone CementGuidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsider

23、ationof Postmarket Surveillance RequirementsGuidance Document for Testing Non-articulating, Mechanically Locked Modular Implant ComponentsClass II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-CoatedUncemented Prostheses; Guidance for Indust

24、ry and FDA2.4 ANSI/ASME Standard:3ANSI/ASME B46.11995 Surface Texture (Surface Roughness, Waviness, and Lay)3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 bearing surface, npart of the prosthetic component that articulates against the counter surface of the natural or prosthe

25、ticelbow joint.3.1.2 extension, nrotation of the ulna and radius away from the humerus around the elbow joint axis in the sagittal plane.3.1.3 flexion, nrotation of the ulna and radius towards the humerus around the elbow joint axis in the sagittal plane.3.1.4 hemi-elbow replacement (hemi), nprosthe

26、tic part that substitutes for the natural humero-ulnar, radio-ulnar and/orhumero-radial articulating surfaces in the human elbow in which only one half of the articulating surfaces is replaced. Theprosthesis is expected to articulate with the remaining natural biological surface(s).3.1.5 humeral com

27、ponent, ncomponent fixed to the humerus for articulation with the natural or prosthetic ulnar and/or radialcomponent(s), typically consisting of two major components: a fixation stem, and a bearing surface.3.1.6 interlock, nmechanical design feature used to increase the capture of one component with

28、in another to restrict unwanteddisplacement between components (that is, locking mechanism for modular components such as a bearing surface to a metallicstem component).3.1.7 laxity, nintentional looseness in the fit between linked style elbow prosthetic components (typically the humero-ulnarcompone

29、nts) that allows small, secondary out-of-plane motions during primary motion to avoid a “fully constrained” or “rigid”connection.3.1.8 linked, na style of total elbow prosthesis in which the humeral and ulnar components are physically connected by alinking mechanism to prevent disassociation (disloc

30、ation) while allowing motion in selected directions.3 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.4 Available from Food and Drug Administration (FDA), 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, http:/www.

31、fda.gov.F2887 1723.1.9 non-linked, na style of total elbow prosthesis in which the humeral and ulnar components are not physically connectedby a linking mechanism. These components rely on soft tissue or another mechanism to minimize the potential for disassociation(dislocation) of the two component

32、s.3.1.10 pronation, nrotation of the radius medially about the ulna around a superior-inferior axis.3.1.11 radial component, ncomponent fixed to the radius for articulation with the natural or prosthetic humeral and/or ulnarcomponent(s), typically consisting of two major components: a fixation stem

33、and a bearing surface.3.1.12 subluxation, ninstability or partial dislocation which occuroccurs when the relative translational or rotational motionbetween the humeral and ulnar components reaches an extreme where the two components would cease to articulate over thedesignated low-friction bearing s

34、urfaces.3.1.13 supination, nrotation of the radius laterally about the ulna around a superior-inferior axis.3.1.14 total elbow replacement (TER), nprosthetic parts that substitute for, at a minimum, the natural opposing humeral andulnar articulating surfaces in the human elbow. This includes both hu

35、mero-ulnar type devices that are intended to function withor without the natural radial head and humero-ulnar with humero-radial option type devices that are intended to replace all threenatural articular surfaces of the elbow.3.1.15 ulnar component, ncomponent fixed to the ulna for articulation wit

36、h the natural or prosthetic humeral and/or radialcomponent(s), typically consisting of two major components: a fixation stem and a bearing surface.3.1.16 valgus, ndeviation of the ulna away from the midline of the body in the frontal plane.3.1.17 varus, ndeviation of the ulna towards the midline of

37、the body in the frontal plane.4. Classification4.1 The following classification by degree of constraint is suggested for all total joint prostheses including total elbowreplacement systems based on the concepts adopted by the U.S. Food and Drug Administration (see (21 CFR 888.6, 21 CFR888.3150, 21 C

38、FR 888.3160, 21 CFR 888.3170, 21 CFR 888.3180; see 2.3).4.1.1 ConstrainedA “constrained” joint prosthesis is used for joint replacement and prevents dislocation of the prosthesis inmore than one anatomic plane and consists of either a single, flexible, across-the-joint component or more than one com

39、ponentlinked together or affined.4.1.2 Semi-constrainedA “semi-constrained” joint prosthesis is used for joint replacement and limits translation and rotationof the prosthesis in one or more planes via the geometry of its articulating surfaces. It has no across-the-joint linkage.4.1.3 Currently, mos

40、t TERs are considered either semi-constrained or constrained. However, devices within a particularclassification may allow varyingvarious degrees of freedom (that is translation, rotation, and so forth). is, translation(s) androtation(s). Currently, TERs which contain a linkage mechanism are classif

41、ied as “constrained” per 4.1.1 yet these devices areoften referred to as “sloppy hinge” or “linked, semi-constrained” in the peer-reviewed literature in reference to the laxity built intothe linkage mechanism to prevent a completely constrained (rigid) connection. These types of devices allow some a

42、mount ofvarus/valgus and rotary motion between the humeral and ulnar components in addition to the primary flexion/extension motion.Devices without this additional laxity are often referred to as “fully constrained” in the literature. See X2.4 for additionaldiscussion.5. Material5.1 The choice of ma

43、terials is understood to be a necessary but not sufficient assurance of function of the device made fromthem.All devices conforming to this specification shall be fabricated from materials with adequate mechanical strength, durability,corrosion resistance, biocompatibility, and wear resistance.5.1.1

44、 Mechanical StrengthVarious metallic components of elbow replacement devices have been successfully fabricated frommaterials, as examples, found in ASTM Specifications F75, F90, F136, F799, F1108, F1377, F1472, and F1537 and ISO 58323.Polymeric bearing components have been fabricated from ultra high

45、 molecular weight polyethylene (UHMWPE) as an example,as specified in Specification F648, Guide F2759, or ISO 58342. Porous coatings have been fabricated from example materialsspecified in Specifications F75, F136, F1377, and F1580. Not all of these materials may possess sufficient mechanical streng

46、th forcritical, highly stressed components or for articulating surfaces. Conformances of a selected material to its standard and successfulclinical usage of the material in a previous implant design are not sufficient to ensure the strength of an implant. Manufacturingprocesses and implant design ca

47、n strongly influence material properties and performance. Therefore, regardless of the materialselected, the elbow prosthesis shall meet the performance requirements of Section 6 of this specification.5.1.2 Corrosion ResistanceMaterials with limited or no history of successful use for orthopaedic im

48、plant application shall bedetermined to exhibit corrosion resistance equal to or better than one of the materials listed in 5.1.1 when tested in accordance withTest Method F746. If the corrosion resistance of a material is less than one of the materials listed in 5.1.1 when tested in accordanceto Te

49、st Method F746, its use shall be justified.5.1.3 BiocompatibilityThe biocompatibility of materials used shall be evaluated using a risk based approach such as thatoutlined in ISO 109931. Practice F748 or ISO 10993 provide guidance on types of biologic tests to perform on materials.F2887 1735.1.4 Friction CharacteristicsBearing surface material couples with limited or no history of successful use for orthopaedicimplant application shall be determined to exhibit equal or better performance than one of the material couples liste