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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.

The rated burst pressure (RBP) of the balloon is determined when located inside a stent. The results of the physical test are used to calculate the RBP statistically and show with at least 95% confidence that 99.9% of the balloons will not burst at or below this value.  


Implant Testing - Balloon Rated Burst Pressure (RBP) - ISO 25539