Tip Flexibility / Tip Stiffness

Determine the flexibility of the guidewire tip by measuring the buckling deformation force.

Test Procedure

The device is placed into a straight path with the stiffness fixture at the distal end of the path. The device is advanced across the fixture until the specified length of the device is exposed from the path. The load cell is then used to bend the device against a normal or oblique wall, to the specified angle while measuring the force. 3 tip span lengths are tested at 2 different angles.

Equipment

– Calibrated dynamometer
– Stepper motor
– Data acquisition system
– Calibrated gauge block
– Tip flexibility fixtures

Measured Parameters

Maximum, minimum and average force
Displacement

Scope

Guidewires

Service Levels

Applicable Standards

FDA-16007
FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling

Related Tests

OLE1212

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