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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.
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
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D695 Test Method for Compressive Properties of Rigid Plastics
D883 Terminology Relating to Plastics
E4 Practices for Force Verification of Testing Machines
E83 Practice for Verification and Classification of Extensometer Systems
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F1714 Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
F1715 Guide for Wear Assessment of Prosthetic Knee Designs in Simulator Devices
F2003 Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
F2102 Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)