Medical Devices

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In the ever-evolving landscape of medical devices, technological innovations have continually propelled the industry forward, revolutionizing patient care. At the forefront of medical innovations stands medical devices. Today’s medical devices help facilitate the diagnosis, treatment, and monitoring of patients worldwide.
 
It’s hard to imagine medical device manufacturing without leak testing. 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 that encounter any bodily fluids, such as blood, urine or medication. Some of the most commonly leak tested medical devices include:
 

• Single or Multi-Lumen Catheters
• Catheter Luer fittings
• Microfluidic Chips and reagent cartridges
• IV Pumps
• Fluid Bags
• Check Valves and Stopcocks
• Tubing Sets
• Fully sealed IP67 or IPXX medical devices
• Respiratory devices

Medical device leak testing is the cornerstone of LeakMaster’s business. We’ve partnered with the world’s largest medical manufacturers to provide leading-edge technology including turnkey leak testing systems and instrumentation such as our UltraFlow V3, Guardian and Defender, and Stealth leak testers. Our vast experience in the assembly and testing of medical devices provides a unique advantage, allowing us to successfully guide our customers to select the correct leak tester for their application, the first time. 

Several leak testing methods are employed for medical device leak testing, including water immersion, pressure or vacuum decay and mass-flow air testing, and tracer gas. LeakMaster manufactures all air testing methods, and focuses on air leak testing solutions due to their lower cost, ease of use and testing accuracy including:
 

Pressure Decay

This popular air leak test method involves pressurizing the medical device with a specified air pressure. After a stabilization period, the instrument monitors for any decrease in air pressure over time, indicating a leak. 
 

Vacuum Decay

Operating opposite to pressure decay, with vacuum decay the part is evacuated and monitored for a pressure rise (loss of vacuum) indicating a leak. A secondary method for sealed components places the medical device in a sealed chamber and extracts surrounding air. An increase in chamber pressure suggests a leak in the test part.

For peace of mind, all LeakMaster leak testers can perform a pressure decay test and most can be optioned to perform a vacuum decay leak test as well. From our budget friendly pressure decay Defender to our configurable, flagship Guardian, LeakMaster provides excellent value and a range of test possibilities within one instrument. 
 

Mass Flow

The mass-flow technique measures the rate at which air flows through a medical device or test piece. With this technique the device is pressurized. Once the pressure is relatively stable, the mass-flow sensor measures the amount of air mass needed to maintain internal device pressure. Continuous air flow into the medical device indicates a leak. A higher air requirement indicates a larger leak.

Our Guardian and UltraFlow leak testers can be configured as pressure decay and mass-flow combination units, providing exceptional value and a range of test options within the same instrument.

For expert advice and quality leak testing solutions, there’s only one LeakMaster.
 

Contact Us

For more information or assistance with your medical device leak testing application, please see our Contact Us page.