ASTM F1781-2003(2009) Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants《弹性挠性关节指杆全连接植入物的标准规范》.pdf

1、Designation: F 1781 03 (Reapproved 2009)Standard Specification forElastomeric Flexible Hinge Finger Total Joint Implants1This standard is issued under the fixed designation F 1781; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, th

2、e year of last revision. A number 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 covers elastomeric flexible hingefinger total joint implants, used with and without metal

3、grommets in the reconstruction of the metacarpophalangeal(MCP) and proximal interphalangeal (PIP) joints.1.2 This specification excludes those implants that do nothave an across-the-joint elastomeric linkage. The specificationis limited to implants made from one material in a singleone-step molding

4、procedure.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:2D 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD 624 Test Method for Tear Strength of Convent

5、ionalVulcanized Rubber and Thermoplastic ElastomersD 813 Test Method for Rubber DeteriorationCrackGrowthD 1052 Test Method for Measuring Rubber DeteriorationCut Growth Using Ross Flexing ApparatusD 2240 Test Method for Rubber PropertyDurometerHardnessF67 Specification for Unalloyed Titanium, for Sur

6、gicalImplant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F86 Practice for Surface Preparation and Marking of Me-tallic Surgical ImplantsF 601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF 748 Practice for Selecting Generic Biological Test Meth-ods for

7、Materials and DevicesF 981 Practice for Assessment 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 2083 Specification for Total Knee ProsthesisF 2042 Guide for Silico

8、ne Elastomers, Gels, and FoamsUsed in Medical Applications Part IICrosslinking andFabrication2.2 Government Standards:21 CFR 820 Good Manufacturing Practices for MedicalDevices3MIL STD 177A Rubber Products, Terms for Visible De-fects32.3 Other Standard:EN 30993-1 Biological Evaluations of Medical De

9、vicesPart 1: Guidance on Selection of Tests43. Significance and Use3.1 The prostheses described in this specification are in-tended for use in the proximal interphalangeal (PIP) andmetacarpophalangeal (MCP) joints.4. Classification4.1 ConstrainedA constrained joint prosthesis is used forjoint replac

10、ement 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.5. Materials and Manufacture5.1 Proper material selection is necessary, but insufficient toen

11、sure suitable functioning of a device.All devices conformingto this specification shall be fabricated from materials withadequate mechanical strength, durability and biocompatibility.5.2 All elastomeric components shall conform to GuidesF 2038 and F 2042. Test and evaluation parameters that couldbe

12、considered for the elastomeric implant materials are Guides1This specification is 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 Feb. 1, 2009. Published March 20

13、09. Originallyapproved in 1997. Last previous edition approved in 2003 as F 1781 03.2For 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 p

14、age onthe ASTM website.3Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/

15、www.ansi.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 2038 and F 2042, Practice F 748, Test Methods D 813,D 1052, D 2240, D 412 and D 624. Before implants can bemanufactured from other materials, manufacturers must com-ply w

16、ith 5.4.5.3 Titanium used as a material of construction for metalgrommets shall conform to Specification F67. Metal grommetsshall match the shape of the implant and not interfere with theflexible hinge implant function.5.4 BiocompatibilityFlexible hinge implants shall bemanufactured from the materia

17、ls listed in 5.2 and 5.3. Beforeimplants can be manufactured from other materials, theirbiocompatibility shall be demonstrated by producing an ac-ceptable response after testing in accordance with PracticesF 748 and F 981, and others (see EN 30993-1) as needed.5.5 When appropriate for metallic gromm

18、ets, fluorescentpenetrant inspection shall be performed in accordance withPractice F 601.5.6 Design and manufacture shall follow 21 CFR 820.6. Performance Requirements6.1 Fatigue TestingThe fatigue characteristics of materialfrom which the elastomeric components are fabricated shall beevaluated acco

19、rding to Test Method D 813. Any test should bedesigned to measure fatigue rate (for example, crack growthlength) as a function of a million(s) cycles.6.2 Range of Motion of the Device Before ImplantationThe implant shall be evaluated to determine the maximumflexion and extension possible before subl

20、uxation occurs or themotion is arrested by the implant (elastomer-to-elastomercontact within the hinge). These results shall be reported in theproduct labeling.6.3 Guidelines for in vitro Laboratory TestingNo ASTMstandards for testing finger implants have been developed.Laboratory testing that simul

21、ates the conditions of use, by ajoint function simulator, is desirable to compare materials anddesigns and to provide an indication of clinical performance.Implant testing shall be done in keeping with the implantsintended function. Implants intended to partially stabilize orstabilize a joint shall

22、be subjected to the maximum destabiliz-ing force or motion, or both, anticipated in clinical applicationduring flexural testing.6.4 DurometerThe hardness of elastomeric componentsshall be measured according to Test Method D 2240.6.5 The mechanical properties (such as tensile strength,percentage elon

23、gation, modulus, and tear strength) of theelastomeric materials used in components shall be determinedaccording to Test Methods D 412 and D 624.7. Dimensions7.1 The following dimensions of finger and joint replace-ment components shall be reported in labeling (see Figs. 1 and2):7.1.1 Distal stem len

24、gth,7.1.2 Proximal stem length,7.1.3 Hinge width in medial/lateral plane,7.1.4 Hinge height in dorsal/palmar plane,7.1.5 Distal stem width,7.1.6 Proximal stem width, and7.1.7 Distal-proximal hinge width.7.2 The following dimensions of finger implant with metalgrommets shall be reported in labeling (

25、see Fig. 3):7.2.1 Distal stem length,7.2.2 Proximal stem length,7.2.3 Distal grommet length,7.2.4 Proximal grommet length, and7.2.5 Hinge height in dorsal/palmar plane.8. Finish and Marking8.1 Items conforming to this specification shall be finishedand marked in accordance with Practices F 86 and F

26、983,where applicable.8.2 Polymeric Surface FinishPolymeric Surface Finishshall conform to manufacturers documented standards con-cerning roughness, knit lines, voids, bubbles, mold fill, color,inclusions, and dimensions, when applicable. Descriptions ofthese terms can be found in MIL STD 177A.9. Lab

27、eling and Packaging9.1 The maximum range of motion values as determined by6.2 shall be included in the product labeling. The minimumFIG. 1 Dimensions of Finger and Joint Replacement ComponentsF 1781 03 (2009)2limits for the mechanical properties of the elastomeric materi-al(s) used in components sha

28、ll be included in the productlabeling.9.2 The dimensions shall be included in the product label-ing.9.3 The material(s) used for the implant shall be specified inthe package labeling.9.4 The site, orientation (if any), and catalog number (ifspace permits) should be present on the component or in the

29、labeling.NOTE 1If space permits, the manufacturers trademark shall appearlegibly on each of the components. If space does not permit this, theinformation shall be in the labeling.10. Keywords10.1 elastomer; finger; implantFIG. 2 Dimensions of Finger and Joint Replacement ComponentsFIG. 3 Dimensions

30、of Finger ImplantF 1781 03 (2009)3APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The objective of this specification is the provision ofguidelines for the physical characteristics of the componentsfor elastomeric total finger joint replacement. Total finger jointreplacement parts are intended f

31、or use in a patient who isskeletally mature under conditions of imposed dynamic loads,in a corrosive environment and subject to motion at the bearingsurfaces, (grommet-hinge interface, hinge-bone interface, orgrommet-bone interface). Laboratory tests for finger jointswhich accurately simulate impose

32、d loads, appropriate rangesof motion, aggressive electrolytes, and the complex constitu-ents of body fluids have not been developed. Long termprojections of satisfactory performance over many decades canbe suggested but not accurately predicted using availablescreening procedures. This document iden

33、tifies those factorsfelt to be important to assure a satisfactory prosthetic life. It isrecognized that failure of an arthroplasty can occur, even whilethe components are intact. This is due to the composite natureof the arthroplasty procedure, which includes the implants, thesurgical procedure, pos

34、t-operative care, patient use, and thephysiological environment.X1.1.1 This specification excludes those implants that donot have an across-the-joint elastomeric linkage and is limitedto implants made from one material in a single, one-stepmolding procedure. It also excludes implants which utilizebo

35、ne cement as affixation method, and implants defined as“partially constrained” or “non-constrained.”X1.1.2 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 ins

36、erted into this standard during the process ofrevision.X1.2 Performance ConsiderationsComponent perfor-mance can be predicted only indirectly at this stage by referringto fatigue performance, range of motion, and other parameters.Reference to parameters applicable to materials may or maynot adequate

37、ly describe a device made from the materials. Inthe future as new materials are developed, other materialtesting methods not described in the standard, such as TestMethod D 1052, may be considered for screening possiblematerials for flexible hinge implants. If these materials aresuitable, this stand

38、ard will be revised to include them aspotential candidate materials for total flexible finger implants.In a period of transition from materials specification standardsto device performance standards, both methods of descriptionmay be appropriate.X1.2.1 Component performance shall be considered withr

39、egard 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 stresses in levels in any component design.When mal-alignment, or dislocation/subluxation occ

40、urs in aMCP or PIP joint reconstructed with a constrained flexiblehinge implant, the forces borne by the implant may causepremature destruction. It is also recognized that other forms ofarthroplasty failure are known to occur, related primarily topatient factors, such as osteoporosis, aggressive rhe

41、umatoiddisease misuse, and others.X1.2.2 Specific criteria need to be established in assessingthe biocompatibility of finger implants made of new materials.Practice F 748 will need to be used to determine whichadditional biocompatibility tests are required.X1.2.3 In the course of evaluating new mate

42、rials, it isrecommended that if the material is used in an application thatcauses small particle formation from abrasion or normal wearprocesses that the biocompatibility of those particles be deter-mined in addition to the bulk material.X1.3 DimensionsThe methods of dimensional measure-ment must co

43、nform with the industry practice and wheneverpossible, on an international practice.X1.4 Finish and MarkingsDimensions and tolerances areas described by manufacturers standards. Material composi-tion can be determined by referring to the manufacturersinformation, instead of marking the material on e

44、ach implant.F 1781 03 (2009)4RELATED MATERIALFrisch, E. E., “High Performance Medical Grade Silicone Elastomer,”Advances in Biomaterials 1, Stuart M. Lee ed., Technomic PublishingCo., Inc., Lancaster, PA, 1987, pp. 143156.Peimer, C. A., Meidige, J., Eckert, B. S., Wright, J. R., Howard, C. S.,“React

45、ive Synovitis After Silicone Arthroplasty,” Journal of HandSurgery, Vol 11, 1986, pp. 624638.Savory, K. M., Hutchinson, D. T., Bloebaum, R., “A Materials TestingProtocol for Small Joint Prostheses,” Transactions for Society forBiomaterials, Vol 17, No. 244, 1994.Schneider, L. H., M.D., and Kirschenb

46、aum, D., M.D., “Arthroplasty at theMetacarpophalangeal Joints,” Operative Techniques in Orthopaedics,Vol 6, 1996, pp. 110116.Swanson, A. B., Swanson, G. de Groot, Frisch, E. E., “Flexible(Silicone)Implant Arthroplasty in the Small Joint Extremities: Concepts, Physicaland Biological Considerations, E

47、xperimental and Clinical Results,”Biomaterials in Reconstructive Surgery, L. R. Rubin, M.D. ed., C. V.Mosby Company St. Louis, MO, Chapter 40, 1983.Wilson, Y. G., Sykes, P. J., and Niranjan, N. S., “Long-Term Follow-Up ofSwansons Silastic Arthroplasty of the Metacarpophalangeal Joints inRheumatoid A

48、rthritis,” Journal of Hand Surgery, Vol 18B, 1993, pp.8191.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such pat

49、ent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by 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 t