This standard provides guidance regarding in vitro conditions, particulate sizing, counting and identification, coating integrity inspections, test equipment, method validation, and reporting requirements for particulate and coating integrity characterization of coated vascular stents and endovascular devices subjected to chronic, cyclic loading conditions.
particle; accelerated; deployment; SEM; EDX; microscope; magnification; recovery; cyclic; expansion; deflection; high speed photography; camera; temperature; particle counter; DES; baseline; coating inspection; drug eluting vascular stent; absorbable
Coating of stents is common and the long-term durability of these coatings needs to be evaluated. USP 788 is not appropriate for this evaluation, nor is there another standard that is applicable. It will be used to provide guidance on how to fulfill regulatory testing requirements aimed at the safety and efficacy of these products for the benefit of patients. The users will be manufacturers of coated stents, test labs and regulatory agencies.
The title and scope are in draft form and are under development within this