1 Scope
1.1 This guide covers select physical and mechanical characterizations of vascular stents
with one or more absorbable components. Such absorbable stents (also referred to as
vascular scaffolds) are used to provide temporary luminal support of the coronary
and peripheral vasculature following interventional revascularization procedures.
This guide covers devices that are fabricated from one or more degradable polymers
and/or metals (from this point on referred to as “absorbable”). This guide provides
a framework for evaluating the change in select physical and mechanical characteristics
of absorbable stents from manufacture through their intended degradation in vivo. Specific testing recommendations are limited to existing ASTM standards for stent
evaluation.

