Burst Pressure Under Static Conditions

The pressure at which the entire catheter assembly bursts.

Test Procedure

Catheter is connected to a pressure manifold and hubs are securely locked. Distil end of the catheter is occluded with a clamp. Catheter is immersed in the fluid at a set temperature of 37C.Hydraulic volume source is applied to the catheter until sufficient force causes the catheter to leak or rupture. Burst or maximum pressure is recorded. If pressure can no longer be increased a leak may be present, and the source of the leak needs to be investigated. Note: This is a potentially hazardous test and great care should be taken to ensure the operator can conduct the test safely.

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-1608
    FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA

  • 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

OLE/QV


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