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Medical Device Leak Testing

The medical device industry faces a number of unique challenges that other markets don’t. What sets Cincinnati Test Systems (CTS) apart from our competition is our extensive knowledge of medical device leak testing applications, process validation, data collection and storage, calibration, and test specifications.

CTS’ Medical Device Leak Test Solutions

CTS offers a variety of medical device leak test solutions that provide reliable results in fast cycle times.We will work with you to determine which device is right for your unique medical device leak testing needs. Contact us to discuss your test requirements.

  • Catheter Testing Solutions: Cincinnati Test Systems offers many catheter testing options, including leak test devices for balloon catheters and multi-lumen catheters.
    • Compliant Balloon Catheters: Used in enteral feeding, tracheotomy tubes, occlusion (vascular/bronchial), drainage (urinary/chest), and more. This type of medical device leak testing often uses a combination of pressure and vacuum decay for verification of inflation/deflation, ramp to burst event, and dilation curve information.
    • Non-Compliant Balloon Catheters: Used in stent delivery, PTA/PTCA, dilation, and more. Catheter testing is often performed using positive pressure and/or vacuum decay testing and verification of inflation/deflation.
    • Multi-Lumen Catheters: Used in hemodialysis, diagnostics, pacing, drug delivery, CVC, PICC, and various other applications. These catheters are often tested using both pressure decay for leak testing and mass flow using multi-port instruments for blockage testing on each individual lumen.Blackbelt Medical Device
  • Bags: Used for IV/saline, hemodialysis, blood transfer, urinary/waste collection, and more. Bag testing is often performed using pressure decay with restraining plates and bag functional testing using ramp to burst event.
  • Check Valves & Pressure Relief Valves: Used in drug/fluid delivery, hemodialysis, blood transfer, and more. Check valve testing is often performed using pressure decay (leak) and cracking/open pressure utilizing ramp to open event (functional).
  • Tubing Sets: Used in drug and solution delivery, blood transfer, and more. Set testing is often performed using pressure and/or vacuum decay testing and occlusion testing.
  • Sheath Introducers: Used for guidewire and catheter entry into blood vessels. Testing often includes pressure and vacuum decay testing as well as occlusion testing.

The Medical Device Leak Testing Experts

CTS works confidentially with partners ranging from global corporations to small, specialized startup ventures. We will work with you to develop a medical device testing solution that is specifically tailored to your unique needs. Request a quote or Contact us today to put our team to work for you.