Torsional Bond Strength
The purpose of this test is to determine the torque required to cause failure of the joints and/or fixed connections in the catheter system.
Test Procedure
Uses the rotation motor and the torque sensor to determine the rotation/torque required to break joints and/or materials in the appropriate device components.
This is often a component level test, and the weakest element of the system typically at locations where adhesives, thermal fusion, or other joining methods are used for bonding components of the delivery system. All bonds must withstand forces greater than those that may be experienced during clinical use.
Measured Parameters
- Failure Mode
- Location of the failure
- Maximum, minimum, mean, and standard deviation of the torsional bond strength
Scope
- PTA, PTCA, coronary and peripheral stent delivery systems – functional performance during simulated use
- TAVI and TMVR delivery systems – functional performance during simulated use
- Thrombectomy devices — functional performance during simulated use
- Guidewires testing – functional performance during simulated use
- Endoscopic devices – functional performance during simulated use
- RF ablation catheters testing – functional performance during simulated use
- Any interventional delivery systems – functional performance during simulated us
Service Levels
Applicable Standards
ISO 25539-2:2020
Cardiovascular implants — Endovascular devices — Part 2: Vascular stentsISO 25539-1:2017
Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
Related Tests
OLE1116
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