BS EN ISO 25539-1:2009 - Page 3

Cardiovascular Implants. Endovascular devices. Endovascular prostheses | Status: Revised, Superseded, Withdrawn

1 Scope 1.1 This part of ISO 25539 specifies requirements for endovascular prostheses, 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.