DIN EN ISO 25539-2:2009-01

This International Standard specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. The scope of this Part 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. Delivery systems are included in the standard if they comprise an integral component of the deployment of the vascular stent.