Balloon Rated Burst Pressure (RBP)
Determination of maximum pressure a balloon can withstand clinically before bursting also known as the rated burst pressure (RBP).
The rated burst pressure (RBP) is the pressure at which 99.9% of balloons can survive with 95% confidence. Failure of a balloon to maintain integrity at the RBP could result in device failure or vessel damage.
The test is performed with an automatic inflation/deflation system.
- Angioplasty balloon catheters
- PTA, PTCA balloon catheters
- Any interventional systems with balloon technology
- Any delivery system with balloon technology
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff
- Balloon Compliance
- Balloon Cyclic Fatigue
- Balloon Inflation Deflation Time
- Air Leakage During Aspiration – Catheter Hub Assembly
- Burst Pressure Under Static Conditions
- Torsional Bond Strength
ViVitro Labs Advantages
Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:
Time to Market
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