EUROLAB laboratory provides testing and compliance services within the scope of ASTM F2003 standard. The purpose of this standard is to allow a researcher to evaluate the oxidative stability of UHMWPE materials as a function of the processing and sterilization method.
This standard describes a laboratory procedure for accelerated aging of ultra-high molecular weight polyethylene (UHMWPE) samples and components for total joint prostheses. UHMWPE is aged at high temperature and high oxygen pressure to accelerate the oxidation of the material, thereby allowing its long-term chemical and mechanical stability to be evaluated.
While the accelerated aging method described by this standard will allow a researcher to compare the oxidative stability of different UHMWPE materials, it is recognized that this method may not fully simulate real-time shelf aging and the disruptive mechanisms for an implant during implantation.
The accelerated aging method outlined herein was validated based on the oxidation levels exhibited by certain shelf-life UHMWPE components packaged in air and sterilized by gamma radiation. The method has not been shown to represent shelf aging when UHMWPE is packaged in a non-air environment. For example, this practice is not directly related to the shelf life of ingredients sealed in a low-oxygen package, such as nitrogen. This application is not intended to simulate any changes that may occur in the UHMWPE following implantation.
Values given in SI units should be accepted as standard. Values in parentheses are for informational purposes only.
This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and to determine the applicability of regulatory restrictions prior to use.
This international standard has been developed in accordance with the internationally accepted principles of standardization set out in the Principles decision on the development of international standards, guidelines and recommendations published by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
EUROLAB assists manufacturers with ASTM F2003 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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