Balloon Inflation Deflation Time
The time to inflate and deflate a balloon catheter to a predefined target pressure is measured.
Test Procedure
The pressure signal is recorded at a predefined high frequency and is used to estimate the inflation and deflation time at a predefined target pressure. Between the inflation and deflation phase, the target pressure is held constant for a specific interval of time.
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-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 Cyclic Fatigue
- Balloon Rated Burst Pressure (RBP)
- Burst Strength – Balloon Method
- Corrosion – Immersion Test
- Air Leakage During Aspiration – Catheter Hub Assembly
- Burst Pressure Under Static Conditions
- Torsional Bond Strength
OLE1003
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