ASTM F1378-2012 Standard Specification for Shoulder Prostheses《肩部修复术的标准规格》.pdf

1、Designation: F1378 12Standard Specification forShoulder Prostheses1This standard is issued under the fixed designation F1378; 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 indica

2、tes the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers shoulder prostheses for total orhemiarthroplasty used to provide functioning articulation byemploying glenoid and humeral components.1.2

3、Devices for custom applications are not covered by thisspecification. Modular prostheses are included in this specifi-cation.1.3 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 Spec

4、ification 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 Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (

5、UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F562 Specification for

6、 Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563)3F603 Specification for High-Purity Dense Aluminum Oxidef

7、or Medical Application3F648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsF746 Test Method for Pitting

8、 or Crevice Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)F981 Practice for Assessment of Compati

9、bility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1044 Test Method for Shear Testing of Calcium PhosphateCoatings and Metallic CoatingsF1108 Specification for Titanium-6Aluminum-4V

10、anadiumAlloy Castings for Surgical Implants (UNS R56406)F1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic CoatingsF1537 Specification for Wrought Cobalt-28Chromium-6MolybdenumAlloys for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)F1829 Test Method for Static Evalu

11、ation of Glenoid Lock-ing Mechanism in ShearF2028 Test Methods for Dynamic Evaluation of GlenoidLoosening or Disassociation2.2 ANSI Standard:4ASME B46.119953. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 collarflange at the junction of the neck and stem.1This specification is

12、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 Jan. 1, 2012. Published January 2012. Originallyapproved in 1992. Last previous edition approved in 2010 as F1378

13、05 (2010).DOI: 10.1520/F1378-12.2For 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 ASTM website.3Withdrawn. The last approved

14、 version of this historical standard is referencedon www.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.2 glenoi

15、d componentthe prosthetic portion that re-places, in part or in total, the glenoid fossa of the scapula andarticulates with the natural humeral head or a prostheticreplacement.3.1.3 headbearing member for articulation with the gle-noid.3.1.4 humeral componentthe prosthetic portion that re-places, in

16、 part or in toto, the proximal humerus or humeral headand articulates with the natural glenoid fossa or a prostheticreplacement.3.1.5 keel, (or pegs)single or multiple projections thatprovide resistance to translation or rotation of the glenoidcomponent, or both, by mating with cavities created in t

17、heglenoid fossa.3.1.6 necksegment connecting the head and the stem.3.1.7 reverse design shoulder implantsimplants that havea ball-shaped glenoid component and a concave humeraldesign.3.1.8 stemsegment intended for insertion within the hu-meral medullary canal.4. Classification4.1 ConstrainedA constr

18、ained joint prosthesis is used forjoint replacement and resists dislocation of the prosthesis inmore than one anatomical plane and consists of either a single,flexible, across-the-joint component or more than one compo-nent linked together or affined.4.2 Partially ConstrainedA semi-constrained joint

19、 pros-thesis is used for partial or total joint replacement and limitstranslation and rotation of the prosthesis in one or more planesvia the geometry of its articulating surfaces. It has no across-the-joint linkages.4.3 UnconstrainedAn unconstrained joint prosthesis isused for partial or total join

20、t replacement and restricts mini-mally prosthesis movement in one or more planes. Its compo-nents have no across-the-joint linkage.5. Materials and Manufacture5.1 The choice of materials is understood to be a necessarybut not sufficient ensurance of function of the device madefrom them.All devices c

21、onforming to this specification shall befabricated from materials, with adequate mechanical strengthand durability, corrosion resistance, and biocompatibility.5.1.1 Mechanical StrengthVarious components of shoul-der prostheses have been successfully fabricated from thefollowing materials. However, n

22、ot all of these materials maypossess sufficient mechanical strength for critical highly-stressed components. See Specifications F75, F90, F136, F138,F562, F563 (nonbearing use only), F603, F648, F745, F799,F1108, and F1537.5.1.2 Corrosion ResistanceMaterials with limited or nohistory of successful u

23、se for orthopedic 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 Method F746.5.1.3 BiocompatibilityMaterials with limited or no his-tory of successful use for orthopedic implant app

24、lication mustbe determined to exhibit acceptable biological response equalto or better than one of the materials listed in 5.1.1 when testedin accordance with Practices F748 and F981.6. Performance Requirements6.1 Wear of Alternative MaterialsIt is important to under-stand the wear performance for a

25、rticulating surfaces. Any newor different material should not exceed the wear rates of thefollowing material couple when tested under physiologicalconditions. The current standard wear couple is CoCrMo alloy(Specification F75) against ultra high molecular weight poly-ethylene (Specification F648), b

26、oth having prosthetic qualitysurface finishes in accordance with 8.2.NOTE 1In situations where the pin-on-flat test may not be consideredappropriate, other test methods may be considered.6.2 Range of Motion of Shoulder Prosthesis Prior toImplantationFlexion shall be equal to or greater than 90.Abduc

27、tion shall be equal to or greater than 90. Internalrotation shall be equal to or greater than 90. External rotationshall be equal to or greater than 45. Extension shall be equalto or greater than 45.6.3 Porous metal coatings shall be tested according to TestMethod F1044 (shear strength) and Test Met

28、hod F1147 (tensilestrength).6.4 Guidelines for In-Vitro Laboratory Testing:6.4.1 Implant testing should reflect current clinical failuresand potential failure modes particular to the implant. Thesetests may be directed towards subluxation, glenoid loosening,insert dissociation from a metal backing,

29、and humeral headdissociation. To facilitate such testing, several references onshoulder forces have been compiled.5, 6, 7Based upon the workby Anglin et al5and Poppen et al,6the normal shoulder jointreaction forces are on the order of 1 to 2 times body weightwith the directions of loading being give

30、n in Figure 3 of thestudy by Anglin et al.5In the design of shoulder implants, thisbackground information of the forces and their directions maybe helpful in determining worst-case shoulder joint forces.However, these joint reaction forces are based upon normalsubjects. In order to generate pass/fai

31、l criterion (that is, forces,angles, and number of cycles) for a particular shoulder pros-thesis, one should take into consideration the anticipatedpatient population, the worst-case physiological loads andangles, an appropriate safety factor, and the potential forunsupported surfaces.6.4.2 All modu

32、lar implants should be tested in accordancewith Test Method F1829.6.4.3 All prosthetic glenoid components shall be capable ofwithstanding sustained static and dynamic physiological forcesof up to 1 times body weight (per 6.4.1) without compromiseof their function for the intended use and environment

33、. Allimplants should be tested for loosening for a clinically relevant5Anglin, C., Wyss, U. P., Pichora, D. R., “Glenohumeral Contact Forces,”Proceedings of the Institution of Mechanical Engineers. Part HJournal ofEngineering in Medicine, 214 (6), 2000, pp. 637644.6Poppen, N. K., Walker, P.S., “Forc

34、es at the Glenohumeral Joint in Abduction,”Clinical Orthopaedics right or left, if applicable).8.4 If one of the components is not radiographically opaque,it is strongly encouraged that it shall contain a marker wire orother means of radiographic detection located at the manufac-turers discretion.9.

35、 Labeling9.1 The dimensions shown in Figs. 1-3 shall be included inthe product labeling.9.2 The material(s) used for the implant shall be specifiedon the package labels and inserts.10. Keywords10.1 arthroplasty; glenoid; humeral; prostheses; hemi-shoulder replacement; total shoulder replacementNOTEA

36、 modular connection may be included in this device.FIG. 1 Humeral Collarless DesignF1378 123APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The objectives of this specification are the provisionof guidelines for the manufacture and use of the componentsfor total shoulder replacement. Total shoul

37、der replacementparts are intended for use in a patient who is skeletally mature,under conditions of imposed dynamic loads, in a corrosiveenvironment, and virtually continuous motion at the bearingsurfaces. Laboratory tests to accurately simulate imposedloads, aggressive electrolytes, and complex con

38、stituents ofbody fluids have not been usefully accelerated at the presenttime for a complete joint evaluation. Long-term projections ofsatisfactory performance over many decades can be suggestedbut not accurately predicted using available screening proce-dures. This specification identifies those fa

39、ctors considered tobe important to assure a satisfactory useful prosthetic life. It ishere recognized that failure of an arthroplasty can occur, evenwhile the components are intact. This is true owing to theNOTEA modular connection may be included in this device.FIG. 2 Humeral Collared DesignNOTE 1I

40、f the glenoid component is not symmetric about the trans-verse plane, a minimum and maximum component width shall bespecified.NOTE 2A modular connection may be included in this device.FIG. 3 Glenoid ComponentsF1378 124composite nature of the arthroplasty procedure, which includesthe implant, cement

41、if any, and the physiological environment.X1.2 Under applicable documents and materials, the listreflects the current state of the art. It is recognized that shouldmaterials not now included appear and be proved acceptable,they shall be inserted in the process of revision.X1.2.1 Performance Consider

42、ationsComponent perfor-mance should be considered with regard to patient anatomy. Itis well recognized that physical stresses resulting from eventsor activities out of the ordinary range, as in accidents orespecially vigorous sports, predictably exceed allowable stresslevels in any component design.

43、 It is also recognized here thatother forms of arthroplasty failure are known to occur, relatedprimarily to patient factors such as osteoporosis, Pagetsdisease, misuse and disuse, and others.X1.2.1.1 No device-specific wear test is specified in thisspecification. It is felt that at this time wear is

44、 not a major issuein existing or potential implant designs, that presently there areno techniques available to do device-specific wear tests andthat this consideration is already partly covered in 6.1.X1.2.1.2 The range of motion parameters are specified asminimum values so that the implant itself d

45、oes not restrictpatient shoulder motion and thus allow potential dislocation orloosing of the implant. Initially the minimum range of motionparameters were larger but they were decreased to those givenin 6.2.X1.2.2 DimensionsThe method of dimensional measure-ment shall be sought to conform with indu

46、stry practice and,whenever possible, on an international basis.X1.2.3 Finish and MarkingsDimensions and tolerancesare as described by ANSI documents for sphericity, concen-tricity, and surface finish.X1.2.3.1 The manufacturers trademark shall appear legiblyon each of the components. It is desirable

47、to have completeinformation, where space is available to do so, including size,orientation if any, and catalog number with date.X1.3 This specification was revised in 2004 to includereverse design shoulder implants.ASTM International takes no position respecting the validity of any patent rights ass

48、erted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time b

49、y the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown