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Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017)
Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017)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
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-
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
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-
(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.
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
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
F2183 − 02 (2008)
FIG. 1 Features of the Small Punch Test Load Versus Displacement Curve for Unirradiated UHMWPE, Including the Peak Load, Ultimate
Load and Displacement, and Work to Failure
3.1.1 peak load—an initial local maximum in the load 5. Apparatus
versus displacement curve (Fig. 1). In certain radiation cross- 5
5.1 Small Punch Test Apparatus —Asystem consisting of a
linked UHMWPE materials, the load versus displacement
hemispherical head punch, a die, and a guide for the punch, as
curve increases monotonically and a shoulder, rather than an
shown in Fig. 2. The parts shall be fabricated from a hardened
initial peak load, may be observed.
steel.
5.1.1 Guide—Thefunctionoftheguideistoalignthepunch
3.1.2 small punch test—a test wherein the specimen is of
relative to the specimen, which rests in a disk-shaped recess.
miniature size relative to conventional mechanical test
The inner diameter of the guide bore shall be 0.1010 +0.0002/-
specimens, is disk-shaped, and is loaded axisymmetrically in
0.0000 in. (2.565 +0.005/-0.000 mm), and the specimen recess
bending by a hemispherical-head punch.
shall be 0.0200 +0.0004/-0.0000 in. (0.508 +0.010/-0.000 mm)
3.1.3 ultimate displacement—the displacement at rupture
in depth and 0.2520 6 0.0005 in. (6.401 6 0.013 mm) in
(failure) of the specimen (Fig. 1).
diameter.
3.1.4 ultimate load—the load at rupture (failure) of the
5.1.2 Die—Thefunctionofthedieistoconstrainthesample
specimen (Fig. 1).
during testing. The inner diameter of the die bore shall be
0.1500 6 0.0005 in. (3.810 6 0.013 mm).
3.1.5 work to failure—the area under the load versus dis-
5.1.3 Punch—The hemispherical head punch shall have a
placement curve (Fig. 1).
diameter of 0.1000 in. (2.540 mm), with a tolerance of
+0.0000/-0.0002 in. (+0.000/-0.005 mm).
4. Significance and Use
5.2 Testing Machine—Any suitable testing machine as de-
4.1 Miniature specimen testing techniques are used to char-
scribed in Method D695, consisting of a drive mechanism and
acterize the mechanical behavior of UHMWPE stock materials
a load indicator. The load indicator shall have a full range of
and surgical implants after manufacture, sterilization, shelf
250 N (56.2 lbs).The accuracy of the machine shall be verified
aging, radiation crosslinking, thermal treatment, and implanta-
at least once per year, as specified by Method D695 and
tion (1). Furthermore, experimental UHMWPE materials can
Practice E4.
be evaluated after accelerated aging and hip or knee wear
5.3 Compressometer—Thisinstrument,describedinSection
simulation. Consequently, the small punch test makes it pos-
5.2 from Method D695, can be used to determine the distance
sible to examine relationships between wear performance and
between the die and the punch during the test. If the actuator
mechanical behavior of UHMWPE. This test method can also
displacementofthetestingmachinecanbeshowntodetermine
be used to rank the mechanical behavior of UHMWPE relative
punch displacement within 1 % of the value measured by a
to a reference control material (such as the NIST Ultra-High
suitably calibrated compressometer (as defined in Practice
Molecular Weight Polyethylene Reference Material #8456).
E83), actuator displacement shall be used as reference.
4.2 Small punch testing results may vary with specimen
preparation and with the speed and environment of testing.
Small punch testers suitable for use and meeting the requirements of this test
Consequently, where precise comparative results are desired,
method are available from Exponent, Inc., 2300 Chestnut St., Suite 150,
these factors must be carefully controlled.
Philadelphia, PA, 19103.
F2183 − 02 (2008)
FIG. 2 Schematic of the Small Punch Test Apparatus, Including the Die, Guide, Hemispherical Head Punch, and Miniature Disk Shaped
Specimen
5.4 Compression Platen—The punch shall rest on a com- 6.3 The standard test specimen shall have a thickness of
pression platen or tool for applying the load to the punch. 0.0200 +0.0002/-0.0003 in. (0.508 +0.005/-0.008 mm) and a
diameter of 0.250 +0.000/-0.005 in. (6.350 +0.000/-0.127
5.5 Micrometers—Suitable micrometers, reading to 0.0001
mm).
in. (0.0025 mm), shall be used to record the diameter and
thickness of the specimens. 6.4 Specimens falling outside the dimensional tolerances
specified in 6.2 shal
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