ASTM F1357-2009 Standard Specification for Articulating Total Wrist Implants《全腕关节植入物的标准规范》.pdf

1、Designation: F 1357 09Standard 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 revision. A number in pa

2、rentheses indicates the year of last reapproval. Asuperscript epsilon () 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 by employing radial

3、 and 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 to be regarded asstandard. No other uni

4、ts of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regu

5、latory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed Titanium, for SurgicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Impl

6、ants(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 (UNS R30605)F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Intersti

7、tial) 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 Implant A

8、pplications (UNS R30563)3F 601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF 603 Specification for High-Purity Dense Aluminum Ox-ide for Medical Application3F 629 Practice for Radiography of Cast Metallic SurgicalImplantsF 648 Specification for Ultra-High-Molecular-We

9、ight 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 Assessmen

10、t 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 Specifica

11、tion for Wrought Cobalt-28Chromium-6MolybdenumAlloys for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)2.2 ANSI/ASME Standard:ANSI/ASME B46.1 Surface Texture (Surface Roughness,Waviness, and Lay)43. Terminology3.1 Definitions:3.1.1 carpal componentarticulating member inserted intoor throu

12、gh the carpal bones.3.1.2 radial componentarticulating member inserted intothe radius for articulation with the carpal component.3.1.3 total wrist replacementprosthetic parts substitutedfor the native opposing radial and carpal articulating surfaces.1This specification is under the jurisdiction of A

13、STM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved Aug. 1, 2009. Published August 2009. Originallyapproved in 1991. Last previous edition approved in 2009 as F 1357 99 (2009).2For referenced A

14、STM 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 version of this historical standard is reference

15、don www.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4. Classification4.1 ConstrainedA constra

16、ined joint prosthesis is used forjoint replacement and prevents 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 join

17、t 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 joi

18、nt replacement and 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 functioning of a device.5.2 All metal implant components sha

19、ll conform to one ofthe following specifications for implant materials: Specifica-tion F67, F75, F90, F 136, F 562, F 563 (nonbearing useonly), F 799, F 1108,orF 1537.5.3 All polymeric components shall conform to Specifica-tion F 648 for implant materials.5.4 All solid ceramic components shall confo

20、rm 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. If implants aremanufactured from other materials, their biocompatibility shallbe considered suitable only if they produce an acceptableresponse afte

21、r testing in accordance with Practice 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 629.6. Performance Requ

22、irements6.1 Polymeric Creep (Cold Flow)Ultra-high molecularweight polyethylene in implant form shall 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 important to under-st

23、and 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 F75) against ultra high molecular weight polyeth

24、yl-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.6.3 Range of Motion of

25、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 labeling.6.4 Guidelines

26、for In-Vitro Laboratory TestingNo ASTMstandards for testing articulating wrist implants have beendeveloped. Laboratory testing that simulates the conditions ofuse is desirable to compare materials and designs and toprovide an indication of clinical performance. Implant testingshall be done in keepin

27、g 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 componentsshould be desi

28、gnated as in Figs. 1 and 2.8. Finish and Marking8.1 Items conforming to this specification shall be finishedand marked in accordance with Practice F86where applicable.8.2 Metallic Bearing SurfaceArticulating surfaces shallbe finished to an average roughness of 0.125 m whenmeasured in accordance with

29、 the principles given in ANSI/ASME B46.1.8.3 Polymeric 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 F86and

30、 F 983. Radial and carpalcomponent marking shall include, if possible, the items belowin the following order of importance:8.4.1 Manufacturer,8.4.2 Size,FIG. 1 Dimensions of Wrist Joint Replacements (Coronal Plane)F13570928.4.3 Catalog Number,8.4.4 Lot Number, and8.4.5 Orientation (dorsal/palmar/rad

31、ial/ulnar/left/right asappropriate).8.5 If one of the components is not radiographic opaque, itshall contain a marker wire or other means of radiographicdetection. If used, it may be located at the manufacturersdiscretion.9. Packaging and Package Marking9.1 The maximum range of motion values as dete

32、rmined by6.3 shall be included in the 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 arthropl

33、asty; prosthesis; total wrist replacementAPPENDIXES(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

34、plane.X1.1.4 Rswmaximum width of the 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

35、 (radial/ulnar plane).X1.1.8 Rwradial 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

36、of carpal com-ponent).X1.1.12 Rcoradial 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 sagitta

37、l plane stem offset(distance of stem 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

38、plane to functional sur-face.X1.1.17 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 c

39、omponent in the dorsal/palmar (sagittal) 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 o

40、f the palm ofthe hand toward the palmar 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)F1357093X1.1.24 radial deviationmovement of the hand towardthe radiu

41、s.X1.1.25 ulnar deviationmovement 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

42、. Total wrist replacement parts 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

43、 complex constituents of body 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 ident

44、ifies those factors felt to be important to assure asatisfactory useful prosthetic life. It is recognized that failure ofan arthroplasty can occur, even while the components areintact. This is true owing to the composite nature of thearthroplasty procedure, which includes the implant, cement (ifany)

45、, and the physiological environment.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 ConsiderationsCo

46、mponent perfor-mance can 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

47、 performancestandards, both methods of description may be appropriate.X2.4 It is recognized that wear between two materials canhave both mechanically and biologically adverse effects. How-ever, section 6.2, Wear of Alternative Materials, applies only tothe mechanical effect of minimizing wear and do

48、es not apply tothe 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, predictablyexcee

49、d allowable stress levels in any component design. It isalso recognized that other forms of arthroplasty failure areknown to occur, related primarily to patient factors, such asosteoporosis, Pagets disease, and misuse.X2.6 Specific criteria need to be established in assessingthe biocompatibility 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 informatio