However, PEEK should be investigated for a higher number of sterilization cycles in order to test its reliability in surgical device applications. Most of these studies performed on PEEK are basically for implant applications, low temperature thermal cycling fatigue, or to investigate the behavior after only a few cycles of sterilization. In another study, the fatigue performance of PEEK was investigated under sterilization and thermal aging cycles and no significant change in fatigue performance of PEEK was found. No significant change in tensile properties was observed, but a decrease of 25% in fatigue strength was observed. The influences of thermal cycling (temperature range between +60 ☌ and −60 ☌, 750 cycles) on the fatigue behavior of carbon/PEEK laminates were also studied. It was reported that after 3 steam sterilization cycles, there was no significant change in elastic modulus, hardness, or coefficient of friction of carbon composite PEEK. The influence of the sterilization process on the micromechanical properties of carbon fiber-reinforced PEEK has been studied for bone implant applications. įor a medical device, which will be used in surgery, the steam sterilization process is mandatory to properly disinfect the device before its next use. However, it was reported that the yielding and plastic flow behavior of PEEK was affected at physiological temperatures. As all implants were subjected to body temperature, which is significantly below the glass transition temperature of PEEK, no significant change in elastic properties of PEEK was observed. Ī thermomechanical study performed on PEEK composite reported the changes in crystallinity, macroscopic decoloration, large deformation in impact, high strain rate, and heating-induced deformation. For implant applications, many PEEK composite materials have been developed, which have been studied for their behavior under mechanical impact, biotribology, friction, dynamic, damage, and fracture. (Thornton Cleveleys, United Kingdom) first offered PEEK commercially as a biomaterial for implant applications in 1998, and since then research on PEEK as a biomaterial has enhanced significantly. In the late 1990s, polyetheretherketone (PEEK) was initially developed as a high-performance thermoplastic to replace metal-based orthopedic and trauma implants. When an unsterilized sample was heated for repetitive cycles without the presence of moisture (121 ☌, 10 and 20 cycles), only ~7% of the maximum change in hardness was observed. Hardness measurement exhibited an increase of ~49% in hardness after just 20 cycles. DSC results exhibited no significant change in the degree of cure and melting behavior of PEEK before and after the sterilization. Vickers hardness and differential scanning calorimetry (DSC) techniques were used to characterize the effects of sterilization. No further significant change in the compression force or dimension was observed for the subsequent sterilization cycles. A significant decrease of ~20% in the compression force of the spring was observed after 30 cycles, and a ~6% decrease in the lateral dimension of the clip was observed after 50 cycles. This clip component was sterilized for a predetermined number of cycles (2, 4, 6, 8, 10, 20…100) at 121 ☌ for 30 min. A spring nature, clip component was selected out of a newly designed medical device (patented) to perform this reliability study. For a reusable medical device, material reliability is an important parameter to decide its lifetime, as it will be subjected to the continuous steam sterilization process. The effects of the sterilization process have been studied on medical grade thermoplastic polyetheretherketone (PEEK).
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