Finite element analysis results can be utilized to determine durability evaluation of medical devices by extracting mean and alternating stress or strain information and then plotting against the constant life curve (fatigue endurance limit) to provide fatigue safety factors of devices. Among a family of devices which have similar geometry and are made of the same material, only the case with the lowest fatigue safety factor under the corresponding loading mode will need to be tested for regulatory submissions.
Constant Life Curve
How do we identify the worst-case device for fatigue life testing
Combined with physical testing of device samples (preferred) or samples subject to identical processing to the device, finite element analysis can also provide constant life curve (fatigue endurance limit) of the devices for the durability evaluation and fatigue safety factor calculation.
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