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
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Time to Market
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