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

• Fast Track
• Standard Service
• Full Service

Applicable Standards

• ISO 25539-2:2020
  Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

• ISO 25539-1:2017
  Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses

Related Tests

• Torque Strength
• Torqueability

OLE1116