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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

Balloon Rated Burst Pressure (RBP) - ISO 25539

Normative References  



ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses.

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

The rated burst pressure (RBP) of the balloon is determined when located inside a stent. The results of the physical test are used to calculate the RBP statistically and show with at least 95% confidence that 99.9% of the balloons will not burst at or below this value.  


Implant Testing - Balloon Rated Burst Pressure (RBP) - ISO 25539


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