1、Designation: F2977 13Standard Test Method forSmall Punch Testing of Polymeric Biomaterials Used inSurgical Implants1This standard is issued under the fixed designation F2977; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year
2、 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 test method covers the determination of mechanicalbehavior of polymeric biomaterials by small punch testing o
3、fminiature disk specimens (0.5 mm in thickness and 6.4 mm indiameter). The test method has been established for character-izing surgical materials after ram extrusion or compressionmolding (1-3)2; for evaluating as-manufactured implants andsterilization method effects (4, 5); as well as for testing
4、ofimplants that have been retrieved (explanted) from the humanbody (6, 7).1.2 The results of the small punch test, namely the peakload, ultimate displacement, ultimate load, and work to failure,provide metrics of the yielding, ultimate strength, ductility, andtoughness under multiaxial loading condi
5、tions. Because themechanical behavior can be different when loaded underuniaxial and multiaxial loading conditions (8), the small punchtest provides a complementary mechanical testing technique tothe uniaxial tensile test. However, it should be noted that thesmall punch test results may not correlat
6、e with uniaxial tensiletest results.1.3 In addition to its use as a research tool in implantretrieval analysis, the small punch test can be used as alaboratory screening test to evaluate new materials withminimal material waste (1).1.4 The small punch test has been applied to other polymers,includin
7、g polymethyl methacrylate (PMMA) bone cement,polyacetal, and high density polyethylene (HDPE), ultra highmolecular weight polyethylene (UHMWPE), and polyethere-therketone (PEEK) (2, 3, 5, 10, 11). This standard outlinesgeneral guidelines for the small punch testing of implantablepolymers.1.5 This st
8、andard 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 regulatory limitations prior to use.2. Referenced Documents2.1
9、 ASTM Standards:3D695 Test Method for Compressive Properties of RigidPlasticsD883 Terminology Relating to PlasticsE4 Practices for Force Verification of Testing MachinesE83 Practice for Verification and Classification of Exten-someter SystemsF1714 Guide for Gravimetric WearAssessment of ProstheticHi
10、p Designs in Simulator DevicesF1715 Guide for Wear Assessment of Prosthetic Knee De-signs in Simulator Devices (Withdrawn 2006)4F2003 Practice for Accelerated Aging of Ultra-High Mo-lecular Weight Polyethylene after Gamma Irradiation inAirF2102 Guide for Evaluating the Extent of Oxidation inUltra-Hi
11、gh-Molecular-Weight Polyethylene FabricatedForms Intended for Surgical Implants3. Terminology3.1 Definitions:3.1.1 small punch test, na test wherein the specimen is ofminiature size relative to conventional mechanical testspecimens, is disk-shaped, and is loaded axisymmetrically inbending by a hemis
12、pherical-head punch.NOTE 1The features of a typical small punch test load versusdisplacement curve for PEEK, UHMWPE, and PMMA bone cement areillustrated in Fig. 1(a-c) and Fig. 2.3.2 Definitions of Terms Specific to This Standard:3.2.1 peak load, nan initial local maximum in the loadversus displacem
13、ent curve (Fig. 2). In certain polymer formu-lations such as radiation crosslinked UHMWPE materials, theload versus displacement curve increases monotonically and a1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct respons
14、ibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved June 1, 2013. Published August 2013. DOI: 10.1520/F2977-13.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.3For referenced ASTM standards, visit the ASTM website, www.astm.
15、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.4The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International, 100 Barr Har
16、bor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1shoulder, rather than an initial peak load, may be observed. Forbrittle materials, the load versus displacement behavior may becompletely linear, in which case no peak load would beobserved.3.2.2 ultimate load, nthe load at rupt
17、ure (failure) of thespecimen that is calculated at the first point before the breakingpoint in the curve where the root of the first derivative is equalto zero (Fig. 2).3.2.3 ultimate displacement, nthe displacement at rupture(failure) of the specimen (Fig. 2).3.2.4 work to failure, nthe area under
18、the load versusdisplacement curve (Fig. 2).4. Significance and Use4.1 Miniature specimen testing techniques are used to char-acterize the mechanical behavior of polymer stock materialsand surgical implants after manufacture, sterilization, shelfaging, radiation crosslinking, thermal treatment, fille
19、rincorporation, and implantation (1-3). Furthermore, experi-mental materials can be evaluated after accelerated aging,fatigue testing, and hip, knee, or spine wear simulation.Consequently, the small punch test makes it possible toexamine relationships between wear performance and me-chanical behavio
20、r. This test method can also be used to rank themechanical behavior relative to a reference control material.4.2 Small punch testing results may vary with specimenpreparation and with the speed and environment of testing.Consequently, where precise comparative results are desired,these factors must
21、be carefully controlled.5. Apparatus5.1 Small Punch Test Apparatus5A system consisting of ahemispherical head punch, a die, and a guide for the punch, asshown in Fig. 3. The parts shall be fabricated from a hardenedsteel.5.1.1 GuideThe function of the guide is to align the punchrelative to the speci
22、men, which rests in a disk-shaped recess.The inner diameter of the guide bore shall be 0.1010 +0.0002/-0.0000 in. (2.565 +0.005/0.000 mm), and the specimen recess5Small punch testers suitable for use and meeting the requirements of this testmethod are available from Exponent, Inc., 2300 Chestnut St.
23、, Suite 150,Philadelphia, PA, 19103.FIG. 1 Representative load versus displacement curves for (a) PEEK, (b) UHMWPE, and (c) PMMA bone cement. Note that the verticalaxis is different for each of these materialsFIG. 2 Features of the small punch test load versus displacementcurve for PEEK, including t
24、he peak load, ultimate load 12.1.2 Method of preparing test specimens;12.1.3 Specimen dimensions;12.1.4 Conditioning procedure used;12.1.5 Temperature in test room;12.1.6 Number of specimens tested;12.1.7 Orientation and location of specimens with respect tooriginal stock material or implant.12.1.8
25、Speed of testing;12.1.9 Average value and standard deviation for initial peakload (if present on the load displacement curve);12.1.10 Average value and standard deviation for ultimateload;12.1.11 Average value and standard deviation for ultimatedisplacement;12.1.12 Average value and standard deviati
26、on for work tofailure;12.1.13 Date of test; and12.1.14 Date of test method.13. Precision and Bias13.1 PrecisionThe repeatability of the small punch testmetrics is reported in the literature to be less than 10% forvirgin, unirradiated UHMWPE materials (1). An interlabora-tory study is currently plann
27、ed to provide quantification ofreproducibility for PEEK and UHMWPE materials.13.2 BiasThere are no recognized standards on which tobase an estimate of bias for this test standard.14. Keywords14.1 mechanical behavior; miniature specimens;polyetheretherketone (PEEK); polymethyl methacrylate(PMMA) bone
28、 cement; small punch test; UHMWPE; ultra-high molecular weight polyethyleneF2977 134REFERENCES(1) Edidin, A. A., Kurtz, S. M., Development and validation of the smallpunch test for UHMWPE used in total joint replacements, FunctionalBiomaterials, Eds. N. Katsube, W. Soboyejo and M. Sacks.Winterthur,
29、Switzerland: Trans Tech Publications Ltd., 2001.(2) Kurtz, S. M., Foulds, J. R., Jewett, C. W., Srivastav, S., and Edidin,A.A., Validation of a small punch testing technique to characterize themechanical behavior of ultra-high molecular weight polyethylene,Biomaterials, 1997; 18: 1659-1663.(3) Jaeke
30、l, D. J., MacDonald, D. W., and Kurtz, S. M., Characterizationof PEEK biomaterials using the small punch test, Journal of Mechani-cal Behavior of Biomedical Materials, 2011, doi:10.1016/j.jmbbm.2011.04.014.(4) Kurtz, S. M., Pruitt, L. A., Jewett, C. W., Foulds, J. R., and Edidin, A.A., Radiation and
31、 peroxide crosslinking promote strain hardeningbehavior and molecular alignment in UHMWPE during multiaxialloading conditions, Biomaterials, 1999; 20: 1449-1462.(5) Kurtz, S. M., Jewett, C. W., Foulds, J. R., and Edidin, A. A., Aminiature-specimen mechanical testing technique scaled to the articu-la
32、ting surface of polyethylene components for total joint arthroplasty,J Biomed Mater Res (Appl Biomater), 1999; 48: 75-81.(6) Edidin, A. A., Rimnac, C. M., Goldberg, V., and Kurtz, S. M.,Mechanical behavior, wear surface morphology, and clinical perfor-mance of UHMWPE acetabular components after 10 Y
33、ears ofimplantation, Wear, 2001; 250: 152-158.(7) Kurtz, S. M., Rimnac, C. M., Pruitt, L., Jewett, C. W., Goldberg, V.,and Edidin, A. A., The relationship between the clinical performanceand large deformation mechanical behavior of retrieved UHMWPEtibial inserts, Biomaterials, 2000; 21: 283-91.(8) K
34、urtz, S. M., Pruitt, L. A., Jewett, C. W., Foulds, J. R., and Edidin, A.A., Radiation and chemical crosslinking promote strain hardeningbehavior and molecular alignment in ultra high molecular weightpolyethylene during multi-axial loading conditions, Biomaterials,1999; 20: 1449-62.(9) Edidin,A.A., J
35、ewett, C. W., Kwarteng, K., Kalinowski,A., and Kurtz,S. M., Degradation of mechanical behavior in UHMWPE after naturaland accelerated aging, Biomaterials, 2000; 21: 1451-1460.(10) Edidin,A.A., Kurtz, S. M., The influence of mechanical behavior onthe wear of four clinically relevant polymeric biomate
36、rials in a hipsimulator, J. Arthroplasty, 2000; 15: 321-331.(11) Giddings, V. L., Kurtz, S. M., Jewett, C. W., Foulds, J. R., andEdidin, A. A., A small punch test technique for characterizing theelastic modulus and fracture behavior of PMMA bone cement usedin total joint replacement, Biomaterials, 2
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