Balloon pressure and corresponding balloon diameter is verified for the full range of recommended inflation diameters.
A compliance chart that correlate balloon diameter to balloon pressure is verified for the full range of recommended inflation diameters. The compliance chart may include pressures up to (but not exceeding) 25% above the Rated Burst Pressure (RBP).
The test is performed with an automatic inflation/deflation system and precision optical microscope.
- Angioplasty balloon catheters
- PTA, PTCA balloon catheters
- Any interventional systems with balloon technology
- Any delivery system with balloon technology
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
Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
- Balloon Cyclic Fatigue
- Balloon Inflation Deflation Time
- Balloon Rated Burst Pressure (RBP)
- Burst Strength – Balloon Method
- Burst Strength
- 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:
Test Method Validation
The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation. ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited. We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.
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.