ASTM F2942-13

1.1This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional.

1.2This guide does not address flat plate, local crush durability, or multi-mode testing.

1.3This guide applies to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents (i.e., stent with a surface layer of an additional material(s)), monolithically polymeric stents, or absorbable stents, although the application of this standard to those products is not precluded.

1.4This guide is applicable to testing of stent(s) (or a representative portion of a stent). While durability testing of coupon samples (e.g., a scaled-up portion of the stent structure) can provide useful information, it is not within the scope of this guide.

1.5This guide applies to endovascular grafts (“stent-grafts”) and other conduit products commonly used to treat aneurismal disease, peripheral vessel trauma, or to provide vascular access. The information provided herein does not address all issues related to testing of these devices.

1.6This guide applies to in vitro modeling of stent durability from non-radial arterial motions. Such motions may arise from musculoskeletal activities, including walking and breathing, and cardiac motion. ASTM F2477 addresses pulsatile (i.e., radial) durability of vascular stents.

1.7This guide does not provide the in vivo physiologic deformation conditions for a vascular stent. It is incumbent upon the user of the standard to develop and justify these boundary conditions (e.g., literature review, in vivo studies, cadaver studies, or modeling of stent vessel interaction) in these durability bench tests. Additional conditions that may be considered include vessel calcification, vessel taper, eccentric lesions, loading excursions (e.g., exercise), and vessel remodeling.

1.8This 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.