This standard specifies the procedure for performing corrosion fatigue tests to obtain SN fatigue curves or statistically derived fatigue strength values, or both, for metallic implant materials. This standard describes the testing of axially loaded fatigue specimens subjected to a constant amplitude, periodic stress function in saline solution at 37°C and in air at room temperature.
The environmental testing method for implant materials can be adapted to other fatigue loading modes such as bending or torsion. While this application is not intended to be applied to fatigue testing on implantable components or devices, it provides guidance for fatigue testing with standard specimens in an environment related to physiological conditions.
Values stated in SI units or inch-pound units will be considered standard separately.
This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory restrictions prior to use.
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