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 requirementsISO 25539-2:2020
Cardiovascular implants — Endovascular devices — Part 2: Vascular stentsFDA-1608
FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDAFDA-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
- Balloon Rated Burst Pressure (RBP)
- Corrosion – Immersion Test
- Air Leakage During Aspiration – Catheter Hub Assembly
- Torsional Bond Strength
OLE/QV
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.
Accredited by A2LA and Cofrac.
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.