Peak Tensile Force / Tensile Bond Strength
Tensile test (uniaxial) to determine the bond strength at locations where adhesives, thermal fusion, or other joining methods are used for bonding components of the delivery system.
Also known as catheter bond strength.
All bonds must withstand tensile forces greater than those that may be experienced during clinical use.
A tensile tester is used. A part of the catheter is held by the stationary jaw of the machine. Each catheter junction is placed on the tensile tester and pulled at a uniform rate of displacement until rupture. Peak tensile force is recorded.
Simulated use preconditioning
Accelerated and real-time aging – Shelf life
Calibrated load cell
Peak tensile force
- 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
FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA
- Balloon Compliance
- Balloon Cyclic Fatigue
- Balloon Inflation Deflation Time
- Balloon Rated Burst Pressure (RBP)
- Corrosion – Immersion Test
- Air Leakage During Aspiration – Catheter Hub Assembly
- Pressurized Internal Diameter
- 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.