AAMI/ISO 25539-2:2012

Specifies requirements for vascular stents, based upon current medical knowledge. Gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. Includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices may or may not incorporate surface modifications of the stent such as drug and/or other coatings.