EndoLab - Implant Testing Services Implant Testing

Profile Effect/Flaring ISO 25539

Normative References  



ISO 25539‐2: Cardiovascular implants - Endovascular devices - Part 2: Vascular stents.

For any pre-mounted balloon-expandable implant, the manufacturer shall evaluate the possible implant radial detachment from its balloon at the proximal and distal ends, during the passage through simulated arterial curvature. The potential for balloon damage during implant placement will also be evaluated. The distance between the external diameter of the implant and the external diameter of the balloon will be measured.  


Implant Testing - Profile Effect/Flaring ISO 25539