Given its relatively simple setup and ability to produce results quickly, rotary bend fatigue testing is becoming commonplace in the medical device industry and is the subject of a new standard test method ASTM E2948-14. Although some research has been conducted to determine if results differ for different rotary bend fatigue test setups or test speeds, these parameters have not been extensively studied together. In this work, we investigate the effects of these two parameters on the fatigue life of three commonly used medical device alloys (ASTM F2063 nitinol, ASTM F138 stainless steel, and ASTM F1058 cobalt chromium). Results with three different rotary bend fatigue test setups revealed no difference in fatigue life among those setups. Increasing test speed, however, between 100 and 35,000 RPM led to an increased fatigue life for all three alloys studied (average number of cycles to fracture increased between 2.0 and 5.1 times between slowest and fastest test speed). Supplemental uniaxial tension tests of stainless steel wire at varying strain rates showed a strain rate dependence in the mechanical response which could in part explain the increased fatigue life at faster test speeds. How exactly strain rate dependence might affect the fatigue properties of different alloys at different alternating strain values requires further study. Given the difference in loading rates between benchtop fatigue tests and in vivo deformations, the potential for strain rate dependence should be considered when designing durability tests for medical devices and in extrapolating results of those tests to in vivo performance.
Keywords: biomaterial; test speed; wire fatigue.