How Should Fatigue Limits For Orthopedic Implant Products Be Obtained?

It is recommended to define the mechanical loading mode and number of fatigue cycle loads of the fatigue test based on the product structural characteristics and intended use, and provide the basis for determining the rationality of the design. The initial fatigue load should be determined based on the static ultimate strength in the corresponding static test. It may be considered that at 75%, 50%, and 25% of the static ultimate strength and under the specified fatigue loading mode and the number of fatigue cycle loads, the sample is deemed to have passed the test if it passes the test without any failure. When determining the fatigue limits, at least the difference between the fatigue limit value and the load causing the structural failure should be guaranteed to be less than 10% of the static ultimate strength, and the number of samples considered pass under this fatigue limit is greater than 1.