1.1 This practice covers the procedure for performing corrosion fatigue tests to obtain S-N fatigue curves or statistically derived fatigue strength values, or both, for metallic implant materials. This practice describes the testing of axially loaded fatigue specimens subjected to a constant amplitude, periodic forcing function in saline solution at 37C and in air at room temperature. The environmental test method for implant materials may be adapted to other modes of fatigue loading such as bending or torsion. While this practice is not intended to apply to fatigue tests on implantable components or devices, it does provide guidelines for fatigue tests with standard specimens in an environment related to physiological conditions.
1.2 The values stated in SI units are to be regarded as the standard.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.