Flexibility Kink Resistance: Measured parameters
- Ability of the device to bend in order to accommodate the predetermined clinically relevant radius or angle it will be required to negotiate during access and delivery
- Flexibility Kink resistance of stent, catheter and interventional devices
Flexibility Kink Resistance: Scope
- Catheters, guidewires, percutaneous heart valves delivery systems, colonoscopes, endoscopes,…
Flexibility Kink Resistance: Applicable standards
- ISO 25539-2 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
- FDA GUIDELINES - GUIDANCE FOR INDUSTRY AND FDA STAFF NON-CLINICAL ENGINEERING TESTS AND RECOMMENDED LABELING FOR INTRAVASCULAR STENTS AND ASSOCIATED DELIVERY SYSTEMS
- GLP STUDIES PER CODE OF FEDERAL REGULATIONS CFR21, PART 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES (APRIL 2010)
- NF EN 14299 (2004) - NON-ACTIVE SURGICAL IMPLANTS. PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS. SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
- ASTM F2606 STANDARD GUIDE FOR THREE-POINT BENDING OF BALLOON EXPANDABLE VASCULAR STENTS AND STENT SYSTEMS
Flexibility Kink Resistance: Related tests
Flexibility Kink Resistance: Test method description
We provide complete programs and engineering solutions to measure the flexibility, and the kink resistance of stent, catheters and other similar devices. We provide validated test methods for measurement and verification of the device bend radius, including methods for verifying that the nominal values disclosed by the manufacturer are within the permitted tolerances.
One of the proposed methods is three point bending against ASTM F2606. The device is positioned on a specific bench fixture. The sample stands horizontally, perpendicular to the 2 lower static supports, with the applied deflection site centered between them. Displacements and forces are recorded.