ISO 25539

ISO 10555-3

Central venous catheters

ISO 10555-4

Balloon dilation catheters

ISO 10555-5

Over-needle peripheral catheters

ISO 80369-20

Small-bore connectors test methods

Balloon rated fatigue

Normative References

ISO 25539‐1: Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses.

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

The purpose of this test is to evaluate the ability of the balloon to withstand repeated inflation cycles. Using clinically relevant rates, the balloon is inflated to the RBP or maximum diameter for a preset time and deflated again. These steps are repeated for a minimum of 10 cycles.  

Contact Person male

Your contact person

Dipl. Ing. Christian Findeiss

Head of Fatigue Testing & Material Analysis, Head of Vascular Testing