This standard, EN ISO 12417-1:2024, provides general requirements for drug-eluting vascular devices used in cardiovascular implants and extracorporeal systems. It outlines criteria for design, manufacture, testing, and documentation of these medical devices to ensure their safety and efficacy. The document is part of a series that addresses specific aspects of drug-delivery devices within the context of cardiovascular treatment.
*** Please note: This description may not be accurate, please refer to the official documentation.