Abstract

ISO 25539-2:2008 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 ISO 25539-2:2008 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 25539-1:2003. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1:2003 and ISO 25539-2:2008.

Delivery systems are included in ISO 25539-2:2008 if they comprise an integral component of the deployment of the vascular stent.

Some pharmacological aspects of drug eluting stents are addressed in ISO 25539-2:2008, but this document is not comprehensive with respect to the pharmacological evaluation of drug eluting stents.

With the exception of sterilization, ISO 25539-2:2008 does not address requirements for the evaluation of animal tissue products.