Balloon Inflation Deflation Time
The time to inflate and deflate a balloon catheter to a predefined target pressure is measured.
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.
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: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff
- 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
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. Victoria and Marseille labs accredited by A2LA.
Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.
We happily provide Non-Disclosure Agreements for all services, including initial consultation.