Over deze norm
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.
|Engelse titel||Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air|