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.
