ISO 25539-1: Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses
ISO 25539-2: Cardiovascular implants – Endovascular devices – Part 2: Vascular stents.
These tests determine the delivery system’s ability to be pushed or positioned by an operator without bending or buckling. We evaluate the ease of advancing the delivery system into the model (trackability), the ability of the delivery system to be removed from the model (withdrawability) and the ability to transmit torque from the proximal end to the distal end of the catheter (torquability), if applicable. To evaluate trackability and withdrawability, a universal test frame is used. Torquability is tested in a custom test set-up. The vascular model in use is described by ASTM F2394.
