1.1.This guide is intended to provide an experimental methodology to assess and determine the structural fatigue life durability of implantable cardiovascular medical devices. 1.2.This guide is also intended to provide methodologies to determine a lower bound on fatigue life at clinically relevant conditions using measured fatigue life derived in whole or in part from hyper-physiological testing to fracture. 1.3.This guide may be used to assess or characterize device durability in design development and for testing to device product specifications.
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
Ballot Item Approved
Ballot Item Approved as F3211-2017 and Pending Publication