DIN EN ISO 25539-2:2013-05

This part of ISO 25539 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 of ISO 25539 includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices might or might not incorporate surface modifications of the stent such as drug and/or other coatings. Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of ISO 25539-1. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1 and this part of ISO 25539.