Burst Pressure Under Static Conditions
The pressure at which the entire catheter assembly bursts.
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.
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: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA
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
- Balloon Rated Burst Pressure (RBP)
- Corrosion – Immersion Test
- Air Leakage During Aspiration – Catheter Hub Assembly
- Torsional Bond Strength
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