October 15, 2012, Accutek Engineering Team
By: Hunter Everett, Project Engineer
The number of specimens tested to static failure are really to aid in deciding which loads should be used in the dynamic testing, and are not of themselves relevant to the testing in ISO 14801.
The two things fatigue testing in your 510(k) submission should show are:
- When does your implant succeed
- How does your implant fail
To clarify, FDA and ISO 14801 require two and recommend three specimens in dynamic testing to ensure your fatigue curve captures the true fatigue behavior of your device. Two specimens at each load will help you with this, but as your loads go lower and lower it becomes important to have a third specimen since the specification and FDA guidance document calls for 3 total runouts.