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Description of ASTM-F2003 2008ASTM F2003 - 02(2008)Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in AirActive Standard ASTM F2003 | Developed by Subcommittee: F04.15 Book of Standards Volume: 13.01 ASTM F2003Significance and Use This practice summarizes a method that may be used to accelerate the oxidation of UHMWPE components using elevated temperature and elevated oxygen pressure. Under real-time conditions, such as shelf aging and implantation, oxidative changes to UHMWPE after sterilization using high energy radiation may take months or years to produce changes that may result in deleterious mechanical performance. The method outlined in this practice permits the evaluation of oxidative stability in a relatively short period of time (for example, weeks). This practice may also be used to oxidize UHMWPE test specimens and joint replacement components prior to characterization of their physical, chemical, and mechanical properties. In particular, this practice may be used for accelerated aging of UHMWPE components prior to evaluation in a hip or knee joint wear simulator as outlined in Guide F 1714 (hip wear), Guide F 1715 (knee wear), ISO 14242 (hip wear), or ISO 14243 (knee wear), or combination thereof. 1. Scope 1.1 It is the intent of this practice to permit an investigator to evaluate the oxidative stability of UHMWPE materials as a function of processing and sterilization method. This practice describes a laboratory procedure for accelerated aging of ultra-high molecular weight polyethylene (UHMWPE) specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its long-term chemical and mechanical stability. 1.2 Although the accelerated-aging method described by this practice will permit an investigator to compare the oxidative stability of different UHMWPE materials, it is recognized that this method may not precisely simulate the degradative mechanisms for an implant during real-time shelf aging and implantation. 1.3 The accelerated aging method specified herein has been validated based on oxidation levels exhibited by certain shelf-aged UHMWPE components packaged in air and sterilized with gamma radiation. The method has not been shown to be representative of shelf aging when the UHMWPE is packaged in an environment other than air. For example, this practice has not been directly correlated with the shelf life of components that have been sealed in a low-oxygen package, such as nitrogen. This practice is not intended to simulate any change that may occur in UHMWPE following implantation. 1.4 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are for information only and are not considered standard. 1.5 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.
ASTM Standards D883 Terminology Relating to Plastics 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 ISO Standards ISO 14243 Implants for surgery--Wear of total knee joint prosthesesKeywords aging; oxidation; preconditioning; stability; UHMWPE; UHMW PE; ultra-high molecular weight polyethylene; Accelerated aging/testing--surgical devices/applications; Polyethylene (PE) surgical implant applications; Preconditioning; UHMWPE (ultra-high molecular weight polyethylene); ICS Code ICS Number Code 83.080.01 (Plastics in general) DOI: 10.1520/F2003-02R08 ASTM International is a member of CrossRef. ASTM F2003This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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