Leak Testing for Medical Devices

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Medical devices facilitate the diagnosis, treatment, and monitoring of patients worldwide. As such, ensuring leak integrity for medical devices is one of the most critical requirements in the medical industry. Leaks in medical equipment can lead to serious consequences, including infections, inaccurate drug delivery, device failure, and patient death. Additional regulatory and patient-safety pressures are making leak testing more important than ever.

LeakMaster proudly supplies several air leak testers for medical devices, designed with intention, performance, durability, and compliance in mind. We provide leak detection systems that are accurate, fast, and reliable over time to ensure your medical devices maintain the highest quality.

Contact us for more information or to begin your leak testing equipment requests today.

Medical Devices Commonly Tested with Leak Detection Technology

Medical devices rely on accurate, repeatable, and high-performance leak testing to ensure safe operation and functionality. Some of the most commonly leak-tested medical devices include:

• Catheters and fluid path components: Single- and multi-lumen catheters, Luer fittings, and tubing sets.
• Fluid delivery systems: IV pumps, fluid bags, check valves, and stopcocks.
• Diagnostic and microfluidic components: Microfluidic chips and reagent cartridges.
• Respiratory and patient-support devices: Ventilator components and fully-sealed IP67/IPXX medical electronics.

Leak integrity is essential for medical components, especially those interacting directly with fluids, medications, or patient environments.

Leak Testers for Medical Devices from LeakMaster

Medical device leak testing is the cornerstone of LeakMaster’s business. Our vast experience in the assembly and testing of medical devices, along with our partnerships with the world’s largest medical device manufacturers, allows us to successfully determine the right leak testers for all customers and medical devices.

We focus on air leak testing solutions that deliver exceptional, reliable test results. We offer a range of air leak detection equipment, with our leading models including:

The Defender

• The Defender is a modern, cost-effective, and reliable pressure decay and vacuum decay leak testing instrument.
• It performs high-volume pressure or vacuum decay testing with speed and accuracy.
• Common uses for medical devices include disposable medical components such as catheters, connectors, and small assemblies.
• Benefits include simple operation, cost effectiveness, and highly stable and repeatable results.

The Stealth

• The Stealth is a compact leak test module designed for integration or benchtop applications, with easy programming and independent operation abilities.
• It is configurable for pressure and vacuum decay, differential pressure, mass flow, and occlusion testing.
• Common applications for medical devices include small parts and assemblies, and standardized pressure decay applications.
• Benefits include fast and stable pressure decay analysis, easy programming, and independent operation.

The Guardian

• The Guardian is a multi-channel capable leak tester ideal for testing pressure or vacuum decay, mass flow, or differential pressure.
• It is a modern and powerful tester designed for long-term production usage.
• Common applications for medical devices include complex or multi-step assemblies, fluid delivery systems, microfluidics, and applications requiring multiple test types.
• Benefits include user identification, data collection, electronic pressure regulation, and stable and repeatable results.

The UltraFlow V3

• The UltraFlow V3 is a high-performing pressure decay and mass flow combination leak test instrument designed for testing large parts at an extremely fast speed with excellent repeatability and ease of use.
• It delivers excellent reliability using high-performance patented hardware and software.
• Common applications for medical devices include microfluidic chips, medical filters, respiratory equipment, and components requiring high mass flow monitoring.
• Benefits include fast measurements and exceptional accuracy.

Leak Testing Methods for Medical Devices

Several leak testing methods are employed for leak detection for medical devices, including water immersion, pressure or vacuum decay, mass-flow air testing, and tracer gas. At LeakMaster, we manufacture all of our testing methods and focus on air leak testing solutions due to their lower cost, ease of use, and high accuracy.

Pressure Decay Testing

Pressure decay testing is one of the most common methods for air leak testing. It involves pressurizing a medical device with a specified pressure, stabilizing the pressure, and monitoring for any decrease in air pressure over time, indicating a leak. The Defender, the Stealth, the Guardian, and the UltraFlow V3 all offer pressure decay measurements.

Vacuum Decay Testing

Vacuum decay testing operates opposite to pressure decay: in this testing method, a part is evacuated and then monitored for any rise in pressure, indicating a leak. Vacuum testing is ideal for sealed or rigid components, as it detects leaks by measuring a loss of vacuum. The Defender and the Guardian are excellent vacuum decay leak testers for medical devices.

Mass Flow Testing

Mass flow testing measures the rate at which air flows through a medical device or test piece. A mass flow sensor monitors a stable, pressurized device, measuring the amount of air mass needed to maintain the internal pressure. Continuous air flow indicates a leak. The Guardian and the UltraFlow V3 leak testers provide high-performance mass flow testing for medical devices.

Why Choose LeakMaster?

LeakMaster has helped ensure leak integrity for medical devices and other applications for more than 20 years. Our expertise, experience, and partnerships with top global manufacturers allow us to create custom turnkey solutions that meet your needs. We serve a variety of industries, offering fast development, support, and additional services to supply high-performance leak testing solutions. Our helpful resources are designed to provide you with expert guidance and information. At LeakMaster, we work directly with you to find the best solutions for your unique requirements.

Contact LeakMaster Today

Get leak detection equipment you can trust from LeakMaster. Contact us to learn more or to speak with a knowledgeable team member. Request a quote to get started on your order today!