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Water Permeability
Wall Thickness
Pressurized Internal Diameter
Relaxed Internal Diameter
Tensile Strength – Circumferential
Ex-Vivo Beating Heart
Sewing Ring Integrity
Dynamic Migration
Experimental Flow Field Assessment – Echo Doppler – Bernoulli’s Equation Verification
Simulated Use Pre-conditioning
Profile Effect / Flaring
Conformability to Vessel Wall
Resistance to damage by flexing
A guidewire can be subjected to flexing or bending during clinical use. The guidewire shall not be damaged and device characteristics shouldn’t be changed to guarantee the intervention success.
This procedure describes the testing to be performed on guidewires to evaluate resistance and damage due to flexing.
Fracture of Guidewires
The guidewire is wrapped around a predefined cylindrical fixture. Once removed the guidewire is examined for visible signs of fracture