Leak and functional testing of disposable medical devices

Medical technology manufacturers face unique challenges that other industries do not have. Product failure at medical devices has a direct impact on patient comfort and can even endanger their lives. For this reason, manufacturers must perform extensive quality testing to ensure that products meet stringent federal health and safety criteria.

Complexity of quality testing for medical devices

Disposable medical devices are available in various sizes and often have complex geometries that can make testing difficult. In addition, the extensibility and elasticity of silicone and other commonly used materials for disposable devices also have a negative effect on the test pressure.

To meet these challenges, the entire solution, from the leak test computer to the quick connectors to the sealing tool, must be specifically designed and configured for medical device testing to achieve accurate test results. As a result, in addition to selecting the right test systems, the competence of the solution partner is extremely important.

We, innomatec and our partner Cincinnati Test Systems (CTS), together with Sciemetric and CTS-Schreiner from the Product Integrity division of the TASI Group. What sets us apart from our competitors is our extensive knowledge of medical device testing applications, the high-quality standards of our products and the global support of the delivered solutions.

We understand the stringent guidelines for device testing in the medical industry and offer reliable leak, flow and blockage leak test computers that can be configured to meet your exact requirements. We support you during implementation and accompany you through to validation.

We work confidentially with partners ranging from global players to small, specialized start-up companies. Our team has extensive experience in the testing of disposable medical devices and will work with you to develop an optimal solution for the testing task, tailored to your individual needs.

Contact us to learn more about our solutions for leak, flow and functional testing and to discuss your specific test criteria.

The following sample video shows how the Sentinel Blackbelt Pro Leak Test Computer can be used to meet the stringent requirements of medical bag pressure testing.

Solutions for catheters, bags and other medical devices

We will work with you to find out which equipment and test methods are suitable for your specific requirements. Contact us to discuss your requirements for testing systems for your medical devices.

  • Non-Compliant Balloon Catheters: Used for stent implantation, PTA/PTCA, dilatation, and more. Test methods vary slightly for stented and non-stented versions, but both can be tested with the same instrument. A leak test computer with a pressure drop method (using air or nitrogen) is usually used for this purpose.
  • Respiratory Breathing Tubes/Circuits: Often made of corrugated polymer tubing, common variants include single limb, dual limb, coaxial in both heated and non-heated versions. Tubes typically require a positive pressure mass flow leak testing.
  • Medical Solution, Fluid or Blood Bags: Used for IV/saline, hemodialysis, blood transfer, urinary/waste collection, and more. Bag testing is often performed using pressure drop leak test computers with restraining plates.
  • Microfluidic Chips: Also known as lab-on-a-chip or microfluidic cartridges. They are used in a variety of biological diagnostic applications, including analytical separation, detection, fluid control (sampling/mixing) and more. They typically require a two-step testing process to detect leaks and possible blockages on each unique microfluidic pathway within each tip.

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