Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
|Publication Date:||1 May 2009|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
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.