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Balloon rated burst pressure (RBP) 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 rated burst pressure (RBP) of the balloon is determined when used with the stent. The RBP is based upon the results of the test that shows statistically, with at least a 95% confidence that 99.9% of the balloons will not burst at or below this pressure.  


Implant Testing - Balloon rated burst pressure (RBP) ISO 25539