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Medical Balloon Testing
Medical Balloon Testing
Medical Balloon Testing
Poba Medical provides full balloon testing documentation and reports with every balloon project including dimensional and functional results. These results are generated from standard measurement techniques like drop gauges, non-contact laser thickness, crescent designs hydraulic leak and burst pressurization measurements including:
R&D
We manufacture medical balloons in different varieties of Nylon, Pebax, Urethane, PET, Poba 51™, along with different blends of all of the above with 30+ years of experience.
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Helping clinician entrepreneurs bring medical device technologies to market with custom balloon design, device prototyping and speed to market.
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Wall Thickness Measurements
Understand performance characteristics
Tail Dimensions
Ensure balloons are going to wrap to a reliable profile, fit properly on catheter shaft, and minimize sheath requirements for device insertion
Diameter Growth Compliance
Understand how balloon is going to grow under pressure, understand rated burst pressure
Rated Burst Pressure
Hydraulic burst tester to understand average and rated burst of all balloon lots
Nominal Diameter Performance
Guarantee that diameter at nominal is where customer is requesting
Visual Defect Inspection
Visually inspecting every balloon for any unacceptable defects throughout the entirety of the balloon shape from tail-to-tail
Sizes, Ranges and Burst Capabilities
Poba Medical operates in an ISO13485 approved ISO-8 cleanroomwith ten (10) dedicated balloon forming production lines capable of balloon production of 25,000 balloons per month/per customer. Additional catheter sub-assembly capability includes:
Diameter
1mm to 45mm
Length
5mm to 320mm
Burst
blow balloons
with RBP (rated burst pressure) of up to 48 atm - 700 PSI
Compliance
Balloons from non-compliant to semi-compliant; Materials from polyurethane to multi-layer nylons
Sizes, Ranges and Burst Capabilities
Poba Medical operates in an ISO 14644 Class 8 (100,000) cleanroom with ten (10) dedicated balloon forming production lines capable of producing 25,000 balloons per month/per customer. Additional catheter sub-assembly capability includes:
Diameter
1mm to 45mm
Length
5mm to 320mm
Burst
Blow balloons
with RBP (rated burst pressure) of up to 48 atm - 700 PSI
Compliance
Balloons from non-compliant to semi-compliant; Materials from polyurethane to multi-layer nylons
