ASTM F1781-2015 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants《弹性挠性全指关节植入物的标准规格》.pdf

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1、Designation: F1781 15Standard Specification forElastomeric Flexible Hinge Finger Total Joint Implants1This standard is issued under the fixed designation F1781; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revis

2、ion. 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 metalgrommets in the reco

3、nstruction 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 procedure.1.3 The va

4、lues stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD624 Test Method for Tear Strength of Conventional Vul-canized Rubb

5、er and Thermoplastic ElastomersD813 Test Method for Rubber DeteriorationCrack GrowthD1052 Test Method for Measuring Rubber DeteriorationCut Growth Using Ross Flexing ApparatusD2240 Test Method for Rubber PropertyDurometer Hard-nessF67 Specification for Unalloyed Titanium, for Surgical Im-plant Appli

6、cations (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF

7、981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF2038 Guide for Silicone Elastomers, Gels, and Foams Usedin Medical Applications Part IFormul

8、ations and Un-cured MaterialsF2042 Guide for Silicone Elastomers, Gels, and Foams Usedin Medical Applications Part IICrosslinking and Fabri-cation2.2 Government Standards:321 CFR 820 Good Manufacturing Practices for MedicalDevicesMIL STD 177A Rubber Products, Terms for Visible De-fects32.3 ISO Stand

9、ard:4ISO 10993-1 Biological Evaluations of Medical Devices Part 1: Evaluation and testing within a risk managementprocess3. Significance and Use3.1 The prostheses described in this specification are in-tended for use in the proximal interphalangeal (PIP) andmetacarpophalangeal (MCP) joints.4. Classi

10、fication4.1 ConstrainedA constrained 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.5. Materials and

11、 Manufacture5.1 Proper material selection is necessary, but insufficient toensure suitable functioning of a device.All devices conformingto this specification shall be fabricated from materials with1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials a

12、nd Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved Oct. 1, 2015. Published December 2015. Originallyapproved in 1997. Last previous edition approved in 2009 as F1781 03 (2009).DOI: 10.1520/F1781-15.2For referenced ASTM standards, visit the ASTM

13、 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.3Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail St

14、op: 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:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1ade

15、quate mechanical strength, durability and biocompatibility.All elastomeric components shall conform to Guides F2038and F2042.5.2 Test and evaluation parameters that could be consideredfor the elastomeric implant materials are Test Methods D813,D1052, D2240, D412 and D624. Before implants can bemanuf

16、actured from other materials, manufacturers shall com-ply with 5.3.5.3 BiocompatibilityFlexible hinge implants shall bemanufactured from the materials listed in 5.2 and 5.3. Beforeimplants can be manufactured from other materials, theirbiocompatibility shall be demonstrated by producing an ac-ceptab

17、le response after testing in accordance with PracticesF748 or ISO 10993-1.5.4 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.5.5 When approp

18、riate for metallic grommets, fluorescentpenetrant inspection shall be performed in accordance withPractice F601.5.6 Design and manufacture shall follow 21 CFR 820.6. Performance Requirements6.1 Fatigue TestingThe fatigue characteristics of materialfrom which the elastomeric components are fabricated

19、 shall beevaluated according to Test Method D813. 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 extensio

20、n possible before subluxation 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.Laborat

21、ory testing that simulates 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 orst

22、abilize a joint shall 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 D2240.6.5 The mechanical properties (such as tensile str

23、ength,percentage elongation, modulus, and tear strength) of theelastomeric materials used in components shall be determinedaccording to Test Methods D412 and D624.7. Dimensions7.1 The following dimensions of finger and joint replace-ment components shall be reported in labeling (see Figs. 1 and2):7.

24、1.1 Distal stem length,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 rep

25、orted in labeling (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 Pr

26、actices F86 and F983, whereapplicable.8.2 Polymeric Surface FinishPolymeric Surface Finishshall conform to manufacturers documented standards con-cerning roughness, knit lines, voids, bubbles, mold fill, color,FIG. 1 Dimensions of Finger and Joint Replacement ComponentsF1781 152inclusions, and dimen

27、sions, when applicable. Descriptions ofthese terms can be found in MIL STD 177A.9. Labeling and Packaging9.1 The maximum range of motion values as determined by6.2 shall be included in the product labeling. The minimumlimits for the mechanical properties of the elastomeric materi-al(s) used in compo

28、nents shall 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

29、or in thelabeling.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 Di

30、mensions of Finger ImplantF1781 153APPENDIX(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

31、for 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 impos

32、ed 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 ide

33、ntifies 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, po

34、st-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 utilizeb

35、one 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 in

36、serted 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 adequat

37、ely 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 D1052, 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 flexible total finger jointimplants. In a period of transition from materials specificationstandards to device performance standards, both methods ofdescription may be appropriate.X1.2.1 Component performance shall be considered

39、 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 stresses in levels in any component design.When misalignment or dislocation/subluxation

40、 occurs 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

41、rheumatoiddisease, misuse, and others.X1.2.2 Specific criteria need to be established in assessingthe biocompatibility of finger implants made of new materials.Practice F748 and/or ISO 10993-1 shall be used to determinewhich additional biocompatibility tests are required.X1.2.3 In the course of eval

42、uating new materials, 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 measu

43、re-ment must conform 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 th

44、e material on each implant.F1781 154RELATED 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.

45、,“Reactive 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 K

46、irschenbaum, D., M.D., “Arthroplasty atthe Metacarpophalangeal Joints,” Operative Techniques inOrthopaedics, 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 Considera

47、tions, Experimental 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 inRheu

48、matoid Arthritis,” 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

49、such patent 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