Balloon Rated Burst Pressure (RBP)
Determination of maximum pressure a balloon can withstand clinically before bursting also known as the rated burst pressure (RBP).
Test Procedure
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.
Equipment
The test is performed with an automatic inflation/deflation system.
Scope
- Angioplasty balloon catheters
- PTA, PTCA balloon catheters
- Any interventional systems with balloon technology
- Any delivery system with balloon technology
Service Levels
Applicable Standards
ISO 10555-1:2013
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirementsISO 25539-2:2020
Cardiovascular implants — Endovascular devices — Part 2: Vascular stentsFDA-1545
FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff
Related Tests
- Balloon Compliance
- Balloon Cyclic Fatigue
- Balloon Inflation Deflation Time
- Air Leakage During Aspiration – Catheter Hub Assembly
- Burst Pressure Under Static Conditions
- Torsional Bond Strength
OLE1214
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
We understand how critical your timelines are.
Our expertise and experience ensure your schedule is met and our commitments are delivered on time.
ISO 17025 Accredited
For studies used for regulatory approval this is a must. Victoria and Marseille labs accredited by A2LA.
Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.
Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.