1.1. This guide is intended to provide an experimental methodology to determine the limits in fatigue life of non-internally powered implantable mechanical cardiovascular medical devices. The methodology relies, fully or in part, on fatigue tests at hyper-physiological conditions intended to cause device fractures. 1.2. This guide is also intended to provide methods to determine a lower bound on fatigue life at clinically relevant conditions by extrapolation of measured cycles to fatigue fracture(s) at such hyper-physiological conditions. 1.3. This guide may be employed further to demonstrate device durability for such things as design verification. 1.4. This guide covers the experiment-only Fatigue-to-Fracture (FtF) testing approach and does not cover how this experimental approach can be used in combination with quantitative stress-strain analysis.
Current durability approach is time consuming, not validated and less informative.
KeywordsFatigue; durability; mechanical testing; FEA.
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
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