ASTM F1357-2014 Standard Specification for Articulating Total Wrist Implants《阐明全腕关节植入物的标准规范》.pdf

1、Designation: F1357 09F1357 14Standard Specification forArticulating Total Wrist Implants1This standard is issued under the fixed designation F1357; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number

2、 in parentheses 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, including solid ceramic implants, used to provide functioning articulationby employing rad

3、ial and carpal components.1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces, one-piece elastomeric implants(with or without grommets), and those devices used for custom applications.1.3 The values stated in SI units are to be regarded as standard. No other

4、units of measurement are included in this standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of r

5、egulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNSR50700)F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical

6、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 Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Intersti

7、tial) Alloy for Surgical ImplantApplications (UNS R56401)F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications(UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical ImplantApp

8、lications (UNS R30563) (Withdrawn 2005)3F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsF603 Specification for High-Purity Dense Aluminum Oxide for Medical ApplicationF629 Practice for Radiography of Cast Metallic Surgical ImplantsF648 Specification for Ultra-High-Mol

9、ecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsF746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methods for Materials and DevicesF799 Specification for Cobalt-28Chromium-6Molybdenum

10、 Alloy Forgings for Surgical Implants (UNS R31537, R31538,R31539)F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and BoneF983 Practice for Permanent Marking of Orthopaedic Implant Components1 This specification is under

11、 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 Aug. 1, 2009Nov. 15, 2014. Published August 2009January 2015. Originally approved in 1991. Last previous edition appro

12、ved in 2009 asF1357 99 (2009).F1357 09. DOI: 10.1520/F1357-09.10.1520/F1357-14.2 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 page on

13、 the ASTM website.3 The last approved version of this historical standard is referenced on www.astm.org.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 techni

14、cally possible to adequately depict all changes accurately, ASTM recommends that 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 Bo

15、x C700, West Conshohocken, PA 19428-2959. United States1F1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNSR31538, and UNS R31539)2.2 ANSI/ASM

16、E Standard:ANSI/ASME B46.1 Surface Texture (Surface Roughness, Waviness, and Lay)43. Terminology3.1 Definitions:3.1.1 carpal componentarticulating member inserted into or through the carpal bones.3.1.2 radial componentarticulating member inserted into the radius for articulation with the carpal comp

17、onent.3.1.3 total wrist replacementprosthetic parts substituted for the native opposing radial and carpal articulating surfaces.4. Classification4.1 ConstrainedAconstrained joint prosthesis is used for joint replacement and prevents dislocation of the prosthesis in morethan one anatomical plane and

18、consists of either a single, flexible, across-the-joint component, or more than one component linkedtogether or affined.4.2 Partially ConstrainedA semi-constrained joint prosthesis is used for partial or total joint replacement and limitstranslation and rotation of the prosthesis in one or more plan

19、es via the geometry of its articulating surfaces. It has noacross-the-joint linkages.4.3 UnconstrainedAn unconstrained joint prosthesis is used for partial or total joint replacement and restricts minimallyprosthesis movement in one or more planes. Its components have no across-the-joint linkages.5.

20、 Materials and Manufacture5.1 Proper material selection is necessary, but insufficient to ensure suitable functioning of a device.5.2 All metal implant components shall conform to one of the following specifications for implant materials: Specification F67,F75, F90, F136, F562, F563 (nonbearing use

21、only), F799, F1108, or F1537.5.3 All polymeric components shall conform to Specification F648 for implant materials.5.4 All solid ceramic components shall conform to Specification F603 for implant materials.5.5 BiocompatibilityArticulating implants shall be manufactured from the materials listed inM

22、aterials with limited or nohistory of successful use for orthopedic implant application shall be determined to exhibit acceptable biological responses 5.2 5.4. If implants are manufactured from other materials, their biocompatibility shall beequal to or better than one of the materialslisted in 5.2

23、considered suitable only if they produce an acceptable response after testing when tested in accordance withPracticePractices F748 981 and F981.5.6 When required for metallic implants, fluorescent penetrant inspection shall be performed in accordance with Practice F601.5.7 When required for cast met

24、allic implants, radiography shall be performed in accordance with Practice F629.5.8 Corrosion ResistanceMaterials with limited or no history of successful use for orthopedic implant application shall bedetermined to exhibit corrosion resistance equal to or better than one of the materials listed in

25、5.2 when tested in accordance withTest Method F746.6. Performance Requirements6.1 Polymeric Creep (Cold Flow)Ultra-high molecular weight polyethylene in implant form shall conform to the requirementsdetailed in Specification F648. When creep occurs, it must not impair the function or stability of th

26、e interface.6.2 Wear of Alternative MaterialsIt is important to understand the wear performance for articulating surfaces. Any new ordifferent material couple should not exceed the wear rates of the following material couple when tested under physiologicalconditions. The current wear couple is CoCrM

27、o alloy (Specification F75) against ultra high molecular weight polyethylene. Thisis an industry wide referenced wear couple and is considered by some to be the minimum. It has been proven to provide clinicallyacceptable results.NOTE 1In situations where the pin-on-flat test may not be considered ap

28、propriate, other test methods may be considered.6.3 Range of Motion of the Device Before ImplantationThe implant shall be evaluated to determine the maximumdorsiflexion, palmar flexion, radial deviation, and ulnar deviation possible before subluxation occurs or the motion is arrested bythe implant.

29、These results shall be reported in the product labeling.4 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.F1357 1426.4 Guidelines for In-Vitro Laboratory TestingNo ASTM standards for testing articulating wrist implants ha

30、ve beendeveloped. Laboratory testing that simulates the conditions of use is desirable to compare materials and designs and to provide anindication of clinical performance. Implant testing shall be done in keeping with the implants intended function, that is, implantsintended to partially stabilize

31、or stabilize a joint shall be subjected to the maximum destabilizing force anticipated in clinicalapplication during flexural testing.7. Dimensions7.1 Dimensions of wrist joint replacement components should be designated as in Figs. 1 and 2.8. Finish and Marking8.1 Items conforming to this specifica

32、tion shall be finished and marked in accordance with Practice F86 where applicable.8.2 Metallic Bearing SurfaceArticulating Surface Finishes: Articulating surfaces shall be finished to an average roughness of0.125 m when measured in accordance with the principles given in ANSI/ASME B46.1.8.2.1 Metal

33、lic Bearing SurfaceThe main bearing surface shall have a surface finish no rougher than 0.10 m roughnessaverage, Ra, with a cutoff length of 0.25 mm, when measured in accordance with the principles given inANSI/ASME B46.11995.8.2.2 Polymeric Bearing Surface (if used)The main bearing surface shall ha

34、ve a surface finish no rougher than 2 mroughness, Ra, with a cut-off length of 0.8 mm, when measured in accordance with the principles given in ANSI/ASMEB46.11995.8.3 Polymeric Bearing Surface Finish shall conform to manufacturers documented standards concerning concentricity,sphericity, and surface

35、 roughness, when applicable.8.3 Items conforming to this specification shall be marked in accordance with Practices F86 and F983. Radial and carpalcomponent marking shall include, if possible, the items below in the following order of importance:8.3.1 Manufacturer,8.3.2 Size,8.3.3 Catalog Number,8.3

36、.4 Lot Number, and8.3.5 Orientation (dorsal/palmar/radial/ulnar/left/right as appropriate).8.4 If one of the components is not radiographic opaque, it shall contain a marker wire or other means of radiographic detection.If used, it may be located at the manufacturers discretion.9. Packaging and Pack

37、age Marking9.1 The maximum range of motion values as determined by 6.3 shall be included in the product labeling.FIG. 1 Dimensions of Wrist Joint Replacements (Coronal Plane)F1357 1439.2 The dimensions shown in Figs. 1 and 2 and described in the glossary in Appendix X1 shall be included in the produ

38、ctlabeling.9.3 The material(s) used for the implant shall be specified on the package labels and inserts.10. Keywords10.1 arthroplasty; prosthesis; total wrist replacementAPPENDIXES(Nonmandatory Information)X1. GLOSSARYX1.1 Descriptions of dimensions used in Figs. 1 and 2.X1.1.1 Cslcarpal component

39、stem length.X1.1.2 Rslradial component stem length.X1.1.3 Cswmaximum width of the stem of the carpal component in the radial/ulnar plane.X1.1.4 Rswmaximum width of the stem of the radial component in the radial/ulnar plane.X1.1.5 Cmaximum depth of the stem of the carpal component in the dorsal/palma

40、r plane.X1.1.6 Rmaximum depth of the stem of the radial component in the dorsal/palmar plane.X1.1.7 Cwcarpal component maximum width (radial/ulnar plane).FIG. 2 Dimensions of Wrist Joint Replacements (Sagittal Plane)F1357 144X1.1.8 Rwradial component maximum width (radial/ulnar plane).X1.1.9 Cdcarpa

41、l component maximum dorsal/palmar dimension.X1.1.10 Rdradial component maximum dorsal/palmar dimension.X1.1.11 Ccocarpal component coronal plane stem offset (distance of stem centerline from radial edge of carpal component).X1.1.12 Rcoradial component coronal plane stem offset (distance of stem cent

42、erline from radial edge of radial component).X1.1.13 Csocarpal component sagittal plane stem offset (distance of stem centerline from dorsal edge of carpal component).X1.1.14 Rsoradial component sagittal plane stem offset (distance of stem centerline from dorsal edge of radial component).X1.1.15 Rpt

43、radial plateau thickness; thickness of radial component from transverse resection plane to functional surface.X1.1.16 Cptcarpal plateau thickness; thickness of carpal component from transverse resection plane to functional surface.X1.1.17 Rccradii of curvature at the low point of the carpal componen

44、t in the radial/ulnar (coronal) plane.X1.1.18 Rradii of curvature at the low point of the radial component in the radial/ulnar (coronal) plane.X1.1.19 Rcsradii of curvature at the low point of the carpal component in the dorsal/palmar (sagittal) plane.X1.1.20 Rrsradii of curvature at the low point o

45、f the radial component in the dorsal/palmar (sagittal) plane.X1.1.21 amount of bone resectedamount of bone removed to allow insertion and use of implant (Rpt + Cpt).X1.1.22 palmarflexion (flexion)movement of the palm of the hand toward the palmar surface of the forearm.X1.1.23 dorsiflexion (extensio

46、n)movement of the dorsum of the hand toward the dorsal surface of the forearm.X1.1.24 radial deviationmovement of the hand toward the radius.X1.1.25 ulnar deviationmovement of the hand toward the ulna.X1.1.26 neutral positiona position of the hand that is parallel to the forearm.F1357 145X2. RATIONA

47、LEX2.1 The objective of this specification is the provision of guidelines for the physical characteristics of the components for totalwrist replacement. Total wrist replacement parts are intended for use in a patient who is skeletally mature, under conditions ofimposed dynamic loads, in a corrosive

48、environment and virtually continuous motion at the bearing surfaces. Laboratory tests toaccurately simulate imposed loads, aggressive electrolytes and complex constituents of body fluids have not been usefullyaccelerated at the present time for a complete joint evaluation. Long-term projections of s

49、atisfactory performance over manydecades can be suggested but not accurately predicted using available screening procedures. This specification identifies thosefactors felt to be important to assure a satisfactory useful prosthetic life. It is recognized that failure of an arthroplasty can occur,even while the components are intact. This is true owing to the composite nature of the arthroplasty procedure, which includes theimplant, cement (if any), and the physiological environment.X2.2 Under applicable documents and mate