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
- Flexibility / Kink Resistance
- Fracture of Guidewires
- Corrosion – Immersion Test
- Coating Integrity Optical Inspection
- Acute Particulate Matter Evaluation
OLE2210

resistance of guidewires to damage by flexing

resistance of guidewires to damage by flexing
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