Medical Devices

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Let’s face it, leaks in medical devices can lead to serious consequences, including infections, inaccurate drug delivery, device failure and patient death. As a rule, LeakMaster recommends 100% production leak testing of medical devices, especially devices that encounter bodily fluids, such as blood, urine or medication.

Medical device leak testing is at the center of LeakMaster’s business. Our experience in the assembly and leak testing of medical devices allows us to successfully guide our customers correctly, the first time.

Several leak testing methods are employed for medical device leak testing, including water immersion, Pressure or Vacuum Decay, Mass Flow and Metered Volume/IP67 leak testing. LeakMaster manufactures all air testing methods and focuses on air leak testing solutions due to their lower cost, ease of use and testing accuracy.
 

Pressure Decay Leak Testing

Pressure Decay is the most widely used technique in medical devices due to its low cost and ease of use. In the Stealth leak tester example, several steps occur during a simple pressure decay test.

• Catheter is pressurized to a specified level with clean, dry air.
• Catheter is allowed to stabilize for a short duration (for expansion, cooling).
• Pressure is monitored for any decrease over a set time.
• A drop in pressure indicates the presence of a leak.

Vacuum Decay Leak Testing

Vacuum Decay is another method frequently used in medical device leak testing. This leak testing method functions in a similar yet opposite manner to the pressure decay method. In the Stealth example:

• Valve is evacuated to a specific vacuum level.
• Stabilized for a short duration.
• Monitored for any increase in pressure over a set time.
• An increase in pressure indicates the presence of a leak.

 

Mass Flow Leak Testing

Mass Flow is commonly used in conjunction with or as an alternative to pressure or vacuum decay. With mass flow, the rate at which “replacement” air flows into or through a part is measured. Mass flow is a simple technique, providing highly repeatable leak or flow testing results on a range of medical devices.

• Medical device is sealed and pressurized to target pressure with clean, dry air.
• Device is allowed to stabilize for a short duration.
• The instrument measures the airflow rate needed to maintain the target pressure. Continuous air flow into the part indicates leakage.

As shown with our Guardian, mass flow is particularly important for testing flexible tubing sets and ventilator tubes.
 

Metered Volume/IP67 Leak Testing

Metered Volume is used for testing pre-sealed parts, without a port or passageway. The technique involves placing a sealed part into a chamber, then monitoring the change in pressure (or vacuum) over time that occurs inside the chamber. If the pressure inside of the chamber drops, it indicates air leaking into the product being tested.

LeakMaster manufactures a full line of air leak testers for medical device leak testing. No matter the size, shape, or difficulty of your medical device application, you can count on us to provide robust, customer-tailored Air Leak Detection Equipment for your applications.
 

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