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.

The portion of the guidewire under test is subjected to repeated reverse bending and straightening, then examined for damage and flaking of the coating.

Test Procedure

Distal end testing:

A mark is put at 5 mm (approximately) from the end of the core wire of the guidewire distal end. This portion of the distal end of the guidewire is bend around one former of the test rig and in the opposite direction around the second former. The guidewire is removed from the formers. The guidewire is straightened (manually positioned in straight shape). The bending and straightening procedure is repeated for 20 cycles. The guidewire is inspected using a microscope. The guidewire coating is examined for signs of damage or flaking caused by this procedure.

Guidewire testing excluding distal end:

A portion of guidewire is selected and marked. This portion does not include proximal end or distal end. This portion of the guidewire is bend around one former of the test rig and in the opposite direction around the second former. The guidewire is removed from the formers. The guidewire is straightened (manually positioned in straight shape). The bending and straightening procedure is repeated for 20 cycles. The guidewire is inspected using a microscope. The guidewire coating is examined for signs of damage or flaking caused by this procedure (for coated guidewires).

Equipment

Standardized Bending tool
Ruler
Permanent marker
Microscope (visual inspection only)

Measured Parameters

Damage and flaking of the coating after reverse bending and straightening

Scope

Any interventional guidewires
035 guidewires
014-018 guidewires
Interventional neuroradiological guidewires

Service Levels

Applicable Standards

ISO 11070:2014
Sterile single-use intravascular introducers, dilators and guidewires

Related Tests

OLE2210

resistance of guidewires to damage by flexing

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