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Balloon rated fatigue ISO 25539

Normative References  



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

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

ISO 10555-4: Intravascular catheters – Sterile and single-use catheters – Part 4: Balloon dilatation catheters.

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


Implant Testing - Balloon rated fatigue ISO 25539