ASTM F2183-02(2008)
(Test Method)Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017)
Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017)
SIGNIFICANCE AND USE
Miniature specimen testing techniques are used to characterize the mechanical behavior of UHMWPE stock materials and surgical implants after manufacture, sterilization, shelf aging, radiation crosslinking, thermal treatment, and implantation (1). Furthermore, experimental UHMWPE materials can be evaluated after accelerated aging and hip or knee wear simulation. Consequently, the small punch test makes it possible to examine relationships between wear performance and mechanical behavior of UHMWPE. This test method can also be used to rank the mechanical behavior of UHMWPE relative to a reference control material (such as the NIST Ultra-High Molecular Weight Polyethylene Reference Material #8456).
Small punch testing results may vary with specimen preparation and with the speed and environment of testing. Consequently, where precise comparative results are desired, these factors must be carefully controlled.
SCOPE
1.1 This test method covers the determination of mechanical behavior of ultra-high molecular weight polyethylene (UHMWPE) by small punch testing of miniature disk specimens (0.5 mm in thickness and 6.4 mm in diameter). The test method has been established for characterizing UHMWPE surgical materials after ram extrusion or compression molding (1,2) ; for evaluating as-manufactured implants after radiation crosslinking and sterilization (3,4); as well as for testing of implants that have been retrieved (explanted) from the human body (5,6).
1.2 The parameters of the small punch test, namely the peak load, ultimate displacement, ultimate load, and work to failure, provide metrics of the yielding, ultimate strength, ductility, and toughness of UHMWPE under multiaxial loading conditions. Because the mechanical behavior of UHMWPE is different when loaded under uniaxial and multiaxial loading conditions (3), the small punch test provides a complementary mechanical testing technique to the uniaxial tensile testing specified for medical grade UHMWPE by Specification F 648.
1.3 In addition to its use as a research tool in implant retrieval analysis, the small punch test can be used as a laboratory screening test to evaluate new UHMWPE materials, such as those created by gamma or electron beam irradiation (1). The test method is also well suited for characterization of UHMWPE before and after accelerated aging (for example, Guide F 2003), and in that regard it can provide ranking of the mechanical degradation of different UHMWPE samples after oxidative degradation (4,7).
1.4 The small punch test has been applied to other polymers, including polymethyl methacrylate (PMMA) bone cement, polyacetal, and high density polyethylene (HDPE) (8,9). However, the small punch testing of polymers other than UHMWPE is beyond the scope of this standard.
1.5 The values stated in SI units are to be regarded as standard. The units in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This test method covered the determination of mechanical behavior of ultra-high molecular weight polyethylene (UHMWPE) by small punch testing of miniature disk specimens (0.5 mm in thickness and 6.4 mm in diameter).
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this test method was withdrawn in January 2017 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
General Information
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2183 − 02 (Reapproved 2008)
Standard Test Method for
Small Punch Testing of Ultra-High Molecular Weight
1
Polyethylene Used in Surgical Implants
This standard is issued under the fixed designation F2183; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.5 The values stated in SI units are to be regarded as
standard. The units in parentheses are mathematical conver-
1.1 Thistestmethodcoversthedeterminationofmechanical
sions to inch-pound units that are provided for information
behavior of ultra-high molecular weight polyethylene (UHM-
only and are not considered standard.
WPE) by small punch testing of miniature disk specimens (0.5
1.6 This standard does not purport to address all of the
mm in thickness and 6.4 mm in diameter).The test method has
safety concerns, if any, associated with its use. It is the
been established for characterizing UHMWPE surgical mate-
2
responsibility of the user of this standard to establish appro-
rials after ram extrusion or compression molding (1,2) ; for
priate safety and health practices and determine the applica-
evaluating as-manufactured implants after radiation crosslink-
bility of regulatory limitations prior to use.
ingandsterilization (3,4);aswellasfortestingofimplantsthat
have been retrieved (explanted) from the human body (5,6).
2. Referenced Documents
1.2 The parameters of the small punch test, namely the peak
3
2.1 ASTM Standards:
load, ultimate displacement, ultimate load, and work to failure,
D695 Test Method for Compressive Properties of Rigid
providemetricsoftheyielding,ultimatestrength,ductility,and
Plastics
toughness of UHMWPE under multiaxial loading conditions.
D883 Terminology Relating to Plastics
Because the mechanical behavior of UHMWPE is different
E4 Practices for Force Verification of Testing Machines
when loaded under uniaxial and multiaxial loading conditions
E83 Practice for Verification and Classification of Exten-
(3),thesmallpunchtestprovidesacomplementarymechanical
someter Systems
testing technique to the uniaxial tensile testing specified for
F648 Specification for Ultra-High-Molecular-Weight Poly-
medical grade UHMWPE by Specification F648.
ethylene Powder and Fabricated Form for Surgical Im-
1.3 In addition to its use as a research tool in implant
plants
retrieval analysis, the small punch test can be used as a
F1714 GuideforGravimetricWearAssessmentofProsthetic
laboratory screening test to evaluate new UHMWPE materials,
Hip Designs in Simulator Devices
such as those created by gamma or electron beam irradiation
F1715 Guide for Wear Assessment of Prosthetic Knee De-
4
(1). The test method is also well suited for characterization of
signs in Simulator Devices (Withdrawn 2006)
UHMWPE before and after accelerated aging (for example,
F2003 Practice for Accelerated Aging of Ultra-High Mo-
Guide F2003), and in that regard it can provide ranking of the
lecular Weight Polyethylene after Gamma Irradiation in
mechanical degradation of different UHMWPE samples after
Air
oxidative degradation (4,7).
F2102 Guide for Evaluating the Extent of Oxidation in
1.4 Thesmallpunchtesthasbeenappliedtootherpolymers, Polyethylene Fabricated Forms Intended for Surgical
Implants
including polymethyl methacrylate (PMMA) bone cement,
polyacetal, and high density polyethylene (HDPE) (8,9).
3. Terminology
However, the small punch testing of polymers other than
UHMWPE is beyond the scope of this standard.
3.1 Definitions—The features of a typical small punch test
loadversusdisplacementcurveforUHMWPEareillustratedin
Fig. 1.
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
3
F04.15 on Material Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved May 1, 2008. Published June 2008. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2002. Last previous edition approved in 2002 as F2083 – 02. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2183-02R08. the ASTM website.
2 4
The boldface numbers in parentheses refer to the list of references at the end of The last approved version of this historical standard is referenced on
this standard. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2183 − 02 (2008)
FIG. 1 Features of the Small Punch Test Load Versus Displa
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