Reliable Leak Detection for Medical Devices and Production Components

A number of unique difficulties are faced by the medical device industry that don’t occur in other markets. The failure of products in the medical device field effects the comfort of patients and can endanger their lives.

For this reason, manufacturers must perform complex medical device diagnostic testing to confirm that products adhere to stringent federal health and safety standards.

Medical Device Diagnostic Testing Complexities

Medical devices are supplied in various sizes and commonly feature complicated geometries like valves, tubes, and further components that can make the evaluation of the equipment more difficult. The elasticity and flexibility of silicone and other materials frequently used in medical devices can also influence test pressure.

To solve these challenges, medical device leak testers need to offer correct sealing and an accurate amount of sensitivity and pressure to yield precise test results. It is also crucial to select the right equipment and medical leak testing techniques.

The video below outlines how the Sentinel Blackbelt Pro leak test instrument can be utilized to conform to the strict standards for pressure testing medical bags.



Video Credit: Cincinnati Test Systems

Reliable Equipment Testing Solutions for the Medical Industry

CTS stands out from its competitors due to its expansive knowledge of medical device testing applications, data storage and collection, calibration, test specifications, and process validation.

CTS is knowledgeable about non-fluid leak requirements, their testing specifications and offers dependable medical device leak test instrumentation that can be installed according to customers’ exact requirements.

CTS works in a confidential manner with partners varying from international corporations to specialized, small startup organizations. The team has a wealth of experience in equipment testing and will work with customers to devise a medical leak testing solution that is directly customized to their unique requirements.

Medical Leak Testing Using Pressure Decay and Mass Flow Equipment

CTS products consist of a range of medical device test solutions that offer dependable results in efficient cycle times. The two most widespread techniques for medical leak testing are pressure decay and mass flow, both of which can be performed utilizing CTS medical device leak testers.

What is the Difference Between Mass Flow and Pressure Decay Medical Leak Testing?

The medical device under test is pressurized to test pressure and then pressure is isolated in the component. Air will travel from a high-pressure area to a low-pressure area if a leak is present, generating a decrease in test pressure that is analyzed by the pressure decay instrumentation.

The medical device under test is pressurized to test pressure and held at a constant pressure during the leak test. The presence of a leak is identified by the mass flow instrumentation by quantifying how much air is added to the component under test to keep pressure constant as it looses air.

In both cases, CTS instrumentation has set points that each measurement is compared to, allowing the instrument to compare its measurements for accept and reject identification of non-leaking and leaking parts.

Equipment Testing Options for Catheters, Bags and Other Medical Devices

CTS will work with customers to identify which testing technique and equipment is best for their specific medical device leak testing requirements.

  • Catheter Testing Solutions: Cincinnati Test Systems provides a number of choices for catheter testing, such as leak test devices for multi-lumen catheters and balloon catheters.
    • Compliant Balloon Catheters: Utilized in drainage (chest or urinary), occlusion (bronchial or vascular), tracheotomy tubes, enteral feeding and more. This kind of medical device leak testing frequently employs a mixture of vacuum and pressure decay for the confirmation of inflation or deflation, dilation curve information, and a ramp to burst event.
    • Non-Compliant Balloon Catheters: Utilized in PTA/PTCA, dilation, stent delivery, and more. Catheter testing is usually carried out employing vacuum and/or pressure decay testing and confirmation of inflation or deflation.
    • Multi-Lumen Catheters: Utilized in PICC, CVC, drug delivery, pacing, diagnostics, hemodialysis, and a range of additional applications. These catheters are frequently assessed with both mass flow using multi-port instruments for blockage testing on each distinct lumen and pressure decay for leak testing.
  • Bags: Utilized for urinary or waste collection, blood transfer, hemodialysis, IV or saline, and more. Bag testing is normally carried out using pressure decay with the bag between restraining plates and sometimes functional testing using a ramp to burst event test.
  • Check Valves and Pressure Relief Valves: Utilized in blood transfer, hemodialysis, drug or fluid delivery, and more. Check valve testing is usually carried out employing pressure decay (leak) and cracking/open pressure through the ramp to open event (functional).
  • Tubing Sets: Utilized in solution and drug delivery, blood transfer, among others. Set testing is normally carried out through vacuum and/or pressure decay testing with an additional occlusion testing.
  • Sheath Introducers: Utilized for catheter and guidewire entry into blood vessels. The evaluation often entails vacuum and pressure decay testing, along with occlusion testing.

This information has been sourced, reviewed and adapted from materials provided by Cincinnati Test Systems.

For more information on this source, please visit Cincinnati Test Systems.


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