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:
Test Method Validation
The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation. ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited. We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.
Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.
We happily provide Non-Disclosure Agreements for all services, including initial consultation.