ASTM WK29690

    New Guide for to the Fatigue-to-Fracture (FtF) Methodology for Evaluating Durable Cardiovascular Medical Devices

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    Developed by Subcommittee: F04.30 | Committee F04 | Contact Staff Manager


    1. Scope

    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.


    Fatigue; durability; mechanical testing; FEA.

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:

    Technical Contact:
    Brian Berg


    F04.30 (15-02)

    Negative Votes Need Resolution