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.

Test Procedure

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.

Associated Tests

Simulated use preconditioning

Accelerated and real-time aging – Shelf life

Equipment

Tensile Tester

Calibrated load cell

Measured Parameters

Peak tensile force

Scope

Angioplasty balloon catheters
PTA, PTCA balloon catheters
Any interventional systems with balloon technology
Any delivery system with balloon technology

Service Levels

Applicable Standards

ISO 10555-1:2013
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
FDA-1608
FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA

Related Tests

OLE1005

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