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Vascular implants
 

Radial Fatigue and Durability - ISO 25539/ASTM F2477Radial Fatigue and Durability - ISO 25539/ASTM F2477 Axial, Bending and Torsional Durability Testing - ASTM F2942Axial, Bending and Torsional Durability Testing - ASTM F2942 Resistance to Perpendicularly-applied Load - ISO 25539Resistance to Perpendicularly-applied Load - ISO 25539 Crush Resistance and Radial Force - ISO 25539/ASTM F3067Crush Resistance and Radial Force - ISO 25539/ASTM F3067 Kink Resistance (Flexibility) - ISO 25539/ASTM F3505Kink Resistance (Flexibility) - ISO 25539/ASTM F3505 Stent-free Surface Area and Stent Outer Surface Area - ISO 25539/ASTM F2081Stent-free Surface Area and Stent Outer Surface Area - ISO 25539/ASTM F2081 Dimensional Verification - ISO 25539/ASTM F2081Dimensional Verification - ISO 25539/ASTM F2081 Local Compression - ISO 25539Local Compression - ISO 25539 Stent System Three-point Bending - ASTM F2606Stent System Three-point Bending - ASTM F2606 Corrosion Test of Small Implants - ASTM F2129Corrosion Test of Small Implants - ASTM F2129 Galvanic Corrosion - ASTM F3044Galvanic Corrosion - ASTM F3044
Balloon Deflation Time - ISO 25539Balloon Deflation Time - ISO 25539 Balloon Rated Burst Pressure (RBP) - ISO 25539Balloon Rated Burst Pressure (RBP) - ISO 25539 Balloon Rated Fatigue - ISO 25539Balloon Rated Fatigue - ISO 25539 Dogboning - ISO 25539Dogboning - ISO 25539 Dimensional Verification - ISO 25539/ASTM F2081Dimensional Verification - ISO 25539/ASTM F2081 Dislodgement Force - ISO 25539/ASTM F2394Dislodgement Force - ISO 25539/ASTM F2394 Force to Deploy - ISO 25539Force to Deploy - ISO 25539 Coating Integrity - ASTM F2743Coating Integrity - ASTM F2743 Profile Effect / Flaring - ISO 25539Profile Effect / Flaring - ISO 25539 Simulated Use - ISO 25539Simulated Use - ISO 25539 Tensile Bond Strength - ISO 25539Tensile Bond Strength - ISO 25539 Torsional Bond Strength - ISO 25539Torsional Bond Strength - ISO 25539 Stent Diameter to Balloon Inflation Pressure - ISO 25539Stent Diameter to Balloon Inflation Pressure - ISO 25539 Stent Length - ISO 25539/ASTM F2081Stent Length - ISO 25539/ASTM F2081 Recoil - ISO 25539/ASTM F2079Recoil - ISO 25539/ASTM F2079 Stent System Three-point Bending - ASTM F2606Stent System Three-point Bending - ASTM F2606
Sterile and Single-use Catheters: General Requirements - ISO 10555-1Sterile and Single-use Catheters: General Requirements - ISO 10555-1 Central Venous Catheters - ISO 10555-3Central Venous Catheters - ISO 10555-3 Balloon Dilation Catheters - ISO 10555-4Balloon Dilation Catheters - ISO 10555-4 Over-needle peripheral catheters - ISO 10555-5Over-needle peripheral catheters - ISO 10555-5 Small-bore Connectors Test Methods - ISO 80369-20Small-bore Connectors Test Methods - ISO 80369-20
Intravascular Introducers, Dilators and Guidewires - ISO 11070Intravascular Introducers, Dilators and Guidewires - ISO 11070 Vascular Prostheses - ISO 7198Vascular Prostheses - ISO 7198

Profile Effect / Flaring - ISO 25539

Normative References  



ISO 25539‐2: Cardiovascular implants - Endovascular devices - Part 2: Vascular stents.

The purpose of this test is to determine the difference between the outer diameters of the stent and the outer diameters of the balloon on the proximal and distal ends of the stent. The measurements are performed before and after tracking the delivery system through a tortuous path according to ASTM F2394 using a laser micrometer and a high-resolution measurement microscope.  


Implant Testing - Profile Effect / Flaring - ISO 25539


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