ASTM F1357-1999(2004) Standard Specification for Articulating Total Wrist Implants《全部腕关节植入物的标准规范》.pdf

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1、Designation: F 1357 99 (Reapproved 2004)Standard Specification forArticulating Total Wrist Implants1This standard is issued under the fixed designation F 1357; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revisi

2、on. A number in 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 describes total wrist implants, includ-ing solid ceramic implants, used to provide functioning articu-lation

3、by employing radial carpal components.1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces, one piece elastomeric im-plants (with or without grommets), and those devices used forcustom applications.1.3 The values stated in SI units are standard. The Englishval

4、ues in parentheses are for information only.2. Referenced Documents2.1 ASTM Standards:2F 67 Specification for Unalloyed Titanium, for SurgicalImplant Applications, (UNS R50250, UNS R50550, UNSR50700)F 75 Specification for Cobalt-28Chromium-6MolybdenumAlloy Castings and Casting Alloy for Surgical Imp

5、lants(UNS R30075)F 86 Practice for Surface Preparation and Marking of Me-tallic Surgical ImplantsF 90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Inter

6、stitial) Alloy for SurgicalImplant Applications (UNS R56401)F 562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F 563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implan

7、t Applications (UNS R30563)F 601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF 603 Specification for High-Purity Dense Aluminum Ox-ide for Medical ApplicationF 629 Practice for Radiography of Cast Metallic SurgicalImplantsF 648 Specification for Ultra-High-Molecular-W

8、eight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)F 981 Practice for Assessme

9、nt of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF 983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF 1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants (UNS R56406)F 1537 Specific

10、ation for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)3. Terminology3.1 Definitions:3.1.1 carpal componentarticulating member inserted intoor through the carpal bones.3.1.2 radial componentarticulating member inserted intothe radius for a

11、rticulation with the carpal component.3.1.3 total wrist replacementprosthetic parts substitutedfor the native opposing radial and carpal articulating surfaces.4. Classification4.1 ConstrainedA constrained joint prosthesis is used forjoint replacement and prevents dislocation of the prosthesis inmore

12、 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.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility of

13、Subcommittee F04.22 on Arthroplasty.Current edition approved Apr. 1, 2004. Published April 2004. Originallyapproved in 1991. Last previous edition approved in 1999 as F 1357 - 99.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org.

14、 For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.2 Partially ConstrainedA semi-constrained joint pros-thesis is us

15、ed 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 joint replacement and

16、restricts mini-mally prosthesis movement in one or more planes. Its compo-nents have no across-the-joint linkages.5. Materials and Manufacture5.1 Proper material selection is necessary, but insufficient toensure suitable function of a device.5.2 All metal implant components shall conform to one ofth

17、e following specifications for implant materials: Specifica-tion F 67, F 75, F 90, F 136, F 562, F 563 (nonbearing useonly), F 799, F 1108, or F 1537.5.3 All polymeric components shall conform to the follow-ing specification for implant materials: Specification F 648.5.4 All solid ceramic components

18、 shall conform to Specifi-cation F 603 for implant materials.5.5 BiocompatibilityArticulating implants shall be manu-factured from the materials listed in 5.2-5.4. Before implantscan be manufactured from other materials, their biocompatibil-ity will be considered suitable only if they produce anacce

19、ptable response after testing in accordance with PracticeF 981.5.6 When required for metallic implants, fluorescent pen-etrant inspection shall be performed in accordance with Prac-tice F 601.5.7 When required for cast metallic implants, radiographyshall be performed in accordance with Practice F 62

20、9.6. Performance Requirements6.1 Polymeric Creep (Cold Flow)Ultra-high molecularweight polyethylene in implant form must conform to therequirements detailed in Specification F 648. When creepoccurs, it must not impair the function or stability of theinterface.6.2 Wear of Alternative MaterialsIt is i

21、mportant to under-stand the wear performance for articulating surfaces. Any newor different material couple should not exceed the wear rates ofthe following material couple when tested under physiologicalconditions. The current wear couple is CoCrMo alloy (Speci-fication F 75) against ultra high mol

22、ecular weight polyethyl-ene. This is an industry wide referenced wear couple and isconsidered by some to be the minimum. It has been proven toprovide clinically acceptable results.NOTE 1In situations where the pin-on-flat test may not be consideredappropriate, other test methods may be considered.6.

23、3 Range of Motion of the Device Before ImplantationThe implant shall be evaluated to determine the maximumdorsiflexion, palmar flexion, radial deviation, and ulnar devia-tion possible before subluxation occurs or the motion isarrested by the implant. These results shall be reported in theproduct lab

24、eling.6.4 Guidelines for In-Vitro Laboratory TestingNo ASTMstandards for testing articulating wrist implants have not beendeveloped. Laboratory testing that simulates the conditions ofuse is desirable to compare materials and designs and toprovide an indication of clinical performance. Implant testi

25、ngshall be done in keeping with the implants intended function,that is, implants intended to partially stabilize or stabilize ajoint shall be subjected to the maximum destabilizing forceanticipated in clinical application during flexural testing.7. Dimensions7.1 Dimensions of wrist joint replacement

26、 components shallbe as designated in Figs. 1 and 2.8. Finish and Marking8.1 Items conforming to this specification shall be finishedand marked in accordance with Practice F 86 where applicable.8.2 Metallic Bearing SurfaceArticulate surfaces shall befinished to an average roughness of 0.125 m.8.3 Pol

27、ymeric Bearing Surface Finish shall conform tomanufacturers documented standards concerning concentric-ity, sphericity, and surface roughness, when applicable.8.4 Items conforming to this specification shall be markedin accordance with Practices F 86 and F 983. Radial and carpalcomponent marking sha

28、ll include, as possible, the items belowin the following order of importance:8.4.1 Manufacturer,8.4.2 Size,8.4.3 Catalog Number,8.4.4 Lot Number, and8.4.5 Orientation (dorsal/palmar/radial/ulnar/left/right asappropriate).8.5 If one of the components is not radiographic opaque, itshall contain a mark

29、er wire or other means of radiographicdetection. If used, it may be located at the manufacturersdiscretion.FIG. 1 Dimensions of Wrist Joint Replacements (Coronal Plane)F 1357 99 (2004)29. Packaging and Package Marking9.1 The maximum range of motion values as determined by6.3 shall be included in the

30、 product labeling.9.2 The dimensions shown in Figs. 1 and 2 and described inthe glossary in Appendix X1 shall be included in the productlabeling.9.3 The material(s) used for the implant shall be specifiedon the package labels and inserts.10. Keywords10.1 arthroplasty; prosthesis; total wrist replace

31、mentAPPENDIXES(Nonmandatory Information)X1. GLOSSARYX1.1 Descriptions of dimensions used in Figs. 1 and 2.X1.1.1 Cslcarpal component stem length.X1.1.2 Rslradial component stem length.X1.1.3 Cswmaximum width of the stem of the carpalcomponent in the radial/ulnar plane.X1.1.4 Rswmaximum width of the

32、stem of the radialcomponent in the radial/ulnar plane.X1.1.5 Cmaximum depth of the stem of the carpalcomponent in the dorsal/palmar plane.X1.1.6 Rmaximum depth of the stem of the radial com-ponent in the dorsal/palmar plane.X1.1.7 Cwcarpal component maximum width (radial/ulnar plane).X1.1.8 Rwradial

33、 component maximum width (radial/ulnarplane).X1.1.9 Cdcarpal component maximum dorsal/palmar di-mension.X1.1.10 Rdradial component maximum dorsal/palmar di-mension.X1.1.11 Ccocarpal component coronal plane stem offset(distance of stem centerline from radial edge of carpal com-ponent).X1.1.12 Rcoradi

34、al component coronal plane stem offset(distance of stem centerline from radial edge of radial compo-nent).X1.1.13 Csocarpal component sagittal plane stem offset(distance of stem centerline from dorsal edge of carpal com-ponent).X1.1.14 Rsoradial component sagittal plane stem offset(distance of stem

35、centerline from dorsal edge of radial com-ponent).X1.1.15 Rptradial plateau thickness; thickness of radialcomponent from transverse resection plane to functional sur-face.X1.1.16 Cptcarpal plateau thickness; thickness of carpalcomponent from transverse resection plane to functional sur-face.X1.1.17

36、Rccradii of curvature at the low point of thecarpal component in the radial/ulnar (coronal) plane.X1.1.18 Rradii of curvature at the low point of the radialcomponent in the radial/ulnar (coronal) plane.X1.1.19 Rcsradii of curvature at the low point of thecarpal component in the dorsal/palmar (sagitt

37、al) plane.X1.1.20 Rrsradii of curvature at the low point of the radialcomponent in the dorsal/palmar (sagittal) plane.X1.1.21 amount of bone resectedamount of bone re-moved to allow insertion and use of implant (Rpt+ Cpt).X1.1.22 palmarflexion (flexion)movement of the palm ofthe hand toward the palm

38、ar surface of the forearm.X1.1.23 dorsiflexion (extension)movement of the dorsumof the hand toward the dorsal surface of the forearm.FIG. 2 Dimensions of Wrist Joint Replacements (Sagittal Plane)F 1357 99 (2004)3X1.1.24 radial deviationmovement of the hand towardthe radius.X1.1.25 ulnar deviationmov

39、ement of the hand toward theulna.X1.1.26 neutral positiona position of the hand that isparallel to the forearm.X2. RATIONALEX2.1 The objective of this specification is the provision ofguidelines for the physical characteristics of the componentsfor total wrist replacement. Total wrist replacement pa

40、rts areintended for use in a patient who is skeletally mature, underconditions of imposed dynamic loads, in a corrosive environ-ment and virtually continuous motion at the bearing surfaces.Laboratory tests to accurately simulate imposed loads, aggres-sive electrolytes and complex constituents of bod

41、y fluids havenot been usefully accelerated at the present time for a completejoint evaluation. Long term projections of satisfactory perfor-mance over many decades can be suggested but not accuratelypredicted using available screening procedures. This specifica-tion identifies those factors felt to

42、be important to assure asatisfactory useful prosthetic life. It is here recognized thatfailure of an arthroplasty can occur, even while the componentsare intact. This is true owing to the composite nature of thearthroplasty procedure, which includes the implant, cement ifany, and the physiological e

43、nvironment.X2.2 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.X2.3 Performance ConsiderationsComponent perfor-mance can

44、be predicted only indirectly at this stage, byreferring to strength levels and other parameters. Reference toparameters applicable to materials may or may not adequatelydescribe structures made from them. In a period of transitionfrom device specification standards to device performancestandards, bo

45、th methods of description may be appropriate.X2.4 It is recognized that with wear between two materialscan have both mechanical detrimental and biological adverseeffects. However, section 6.2, Wear of Alternative Materials,applies only to the mechanical effect of minimizing wear anddoes not apply to

46、 the biological issues related to wear.X2.5 Component performance shall be considered withregard to patient anatomy. It is well recognized that physicalstresses resulting from events or activities out of the ordinaryrange, as in accidents or especially vigorous sports, predictablyexceed allowable st

47、ress levels in any component design. It isalso recognized here that other forms of arthroplasty failure areknown to occur, related primarily to patient factors, such asosteoporosis, Pagets disease, misuse and disuse, and others.X2.6 Specific criteria need to be established in assessingthe biocompati

48、bility of articulating wrist implants made of newmaterials. Practice F 748 will need to be used to determinewhich additional biocompatibility tests are required.X2.7 Range of motion data of devices before implantationwill provide comparative information among implants.X2.8 DimensionsThe methods of d

49、imensional measure-ment must be sought to conform with the industry practice and,whenever possible, on an international basis.X2.9 Finish and MarkingsDimensions and tolerances areas described by ANSI documents for sphericity, concentricity,and surface finish. A maximum allowable roughness for thepolymeric bearing surface is not specified at this time, but willbe in the future. It is suggested if needed at the time ofexplanation that the material composition can be determined byreferring to the manufacturers information, instead of marki