Coating integrity ISO 25539

Normative References  

ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses.

ISO 25539‐2: Cardiovascular implants - Endovascular devices - Part 2: Vascular stents.

ASTM F2743: Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent.

The test standards describe recommended in-vitro test procedures for assessing the acute coating durability of coated drug-eluting vascular stent systems. Clinical performance (i.e. drug elution) may be affected by coating durability. Balloon-expandable and self-expanding stents are included within the scope. Recommended practices for assessing acute coating durability include baseline (deployment) testing and simulated use testing. This guide describes the capture and analysis of any particulate released and inspection of the coated stent surface. Analysis of particulates and surface inspection may be accomplished using the same test articles subjected to simulated tracking and deployment, if appropriate.