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 requirements

  • ISO 25539-2:2020
    Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

  • FDA-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

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.

Join over 5000 cardiovascular device professionals who receive our testing and engineering insights and tips every month.