Shelf Life of UHMWPE Components for Total Joint Replacement

Shelf Life of UHMWPE Components for Total Joint Replacement 

Until recently, a consensus practice of 5-year shelf life was adopted in Europe for medical implants so that sterility can be ensured. However, within the past few years, the European Committee for Standardization (CEN) has established standards that limit the shelf life of UHMWPE components to 5 years. Because implants are distributed multinationally, packaging for components sold in the United States may stipulate a 5-year shelf life. However, it should be noted that, even today, there is no U.S. standard for shelf life of UHMWPE components after sterilization by gamma radiation, ethylene oxide, or gas plasma. 

Accelerated aging methods have been developed for evaluating the integrity of medical packaging (ASTM F 1980-02 2002). Nevertheless, because 

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