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

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