Medical Device Leak Testing: Methods, Equipment and Best Practice for Nordic Manufacturers
A leak in a medical device is never a cosmetic defect. It means a compromised fluid path, a broken sterile barrier or a ventilator that fails to deliver. For medtech manufacturers in Sweden, Denmark, Norway and Finland, reliable medical device leak testing protects patients, secures regulatory compliance and safeguards your brand.
This guide explains why leak detection matters, which test methods suit which devices, and how to choose the right equipment for your production line.
Why Leak Testing Is Critical for Medical Devices
Many medical devices deliver fluids to the body or extract them from it. If a leak exists, fluid can reach the wrong location, or the wrong fluid can be removed. Both scenarios put patients and healthcare professionals at risk. Both expose the manufacturer to liability.
Under the EU Medical Device Regulation (MDR) and ISO 13485 quality systems, manufacturers must demonstrate that their production processes are controlled, validated and documented. A robust leak detection method does exactly that. It identifies non-conforming parts before they reach the market and produces the data you need for traceability.
In medtech, sampling is rarely enough. Most manufacturers test every single part. That demands leak testers that are fast, repeatable and easy to verify against calibrated reference leaks.
Which Medical Devices Need Leak Testing?
ATEQ has been leak testing manufactured parts since 1975. In the medical sector, typical applications include:
- Fluid delivery: catheters, IV bags, blood bags, syringes and medical tubing
- Respiratory care: ventilators, inhalers and pressure regulators
- Life-critical devices: pacemakers, dialysis equipment and medical pumps
- Components: medical valves, membranes, filters, transducers and connectors
- Pharmaceutical packaging: blister packs, glass and plastic vials, and aerosol pumps
See the full list of applications on our medical and cosmetic leak testing page.
Leak Testing Methods for Medical Devices
No single method fits every device. The right choice depends on the part volume, the leak rate you need to detect and your cycle time.
Differential Pressure Decay
Differential pressure decay is the global standard for industrial leak detection. The test part and a reference volume are pressurised together, and the instrument measures any pressure difference between them. It is fast, clean and highly sensitive. It suits rigid and semi-rigid parts such as housings, valves and connectors.
Our F620 leak tester offers full-scale ranges from 20 Pa to 5,000 Pa and test pressures from vacuum to 20 bar. For automated lines, the compact F67 mounts close to the test part and networks up to 50 modules.
Flow Testing
Flow testing measures how much air passes through a part, or leaks out of it, in a given time. It is essential for devices where flow is the function: catheters, IV drips, inhalers, dialysis lines and ventilators. ATEQ ventilator test solutions cover flow measurement up to 300 L/min and leak detection down to 0.1 cc/min.
Discover the D620 laminar flow tester, a reference instrument for medical flow and leak applications.
Vacuum Decay
Vacuum decay places the part or package under vacuum and monitors the pressure rise. It is well suited to sealed components and packaging. The F28 LPV combines low-pressure and vacuum decay and can even detect water leaks by evaporation under strong vacuum.
Helium Tracer Gas Detection
When leak rates fall below what air-based methods can measure, tracer gas is the answer. Helium mass spectrometry detects the smallest leaks in implantables, sealed electronics and high-integrity assemblies. Explore the He-490S helium leak detector.
| Method | Best for | Typical devices |
|---|---|---|
| Differential pressure decay | Fast, sensitive inline testing | Valves, connectors, housings |
| Flow testing | Functional flow and leak checks | Catheters, IV drips, ventilators |
| Vacuum decay | Sealed parts and packaging | Vials, blister packs, sealed modules |
| Helium tracer gas | Very small leak rates | Implantables, high-integrity assemblies |
Choosing the Right Leak Tester for Your Production Line
Start with three questions. What leak rate must you reject? What cycle time does your line need? How will results feed your quality system? The answers point to the right instrument.
- F620: benchtop or inline pressure decay testing, 128 programs, ranges down to 20 Pa full scale.
- D620: laminar flow testing for catheters, tubing and respiratory devices.
- F26 Speed: compact pressure decay module for automatic and semi-automatic machines, up to 10 bar.
- F67: high-speed module for multi-station lines, with 0.01 Pa resolution on the 0 to 50 Pa range.
Not sure where to start? Our full product range covers pressure decay, flow, tracer gas and volume testing.
Calibration, Validation and Traceability
In a regulated environment, a leak test is only as good as its proof. Validation requires stable instruments, regular verification and complete records.
- Verify: check test performance against calibrated leak jets at any time.
- Calibrate: maintain accuracy with the CDF7000 multi-range calibrator or our calibration services.
- Record: collect and store results for full traceability with WinATEQ 300 software.
ATEQ instruments also include secure access levels, so only authorised users can create or modify test parameters. That supports the process control expected under ISO 13485.
Leak Testing Support Across the Nordics
With over 275,000 testers installed at more than 5,000 customers worldwide, ATEQ has likely tested a part similar to yours. ATEQ Nordics supports medtech manufacturers in Sweden, Denmark, Norway and Finland from feasibility to production.
- Feasibility: send us your parts and we will test them in our lab.
- Engineering: our engineering team designs complete test solutions, including fixtures and sealing.
- Training: keep your operators and quality teams sharp with ATEQ leak testing training.
Want to estimate a leak rate first? Try the ATEQ leak simulator, or browse our leak testing glossary.
Find the Right Leak Test for Your Medical Device
Tell us about your part. We will recommend the method, the instrument and the setup.
Frequently Asked Questions
What is medical device leak testing?
Medical device leak testing verifies that a device or its packaging contains no leak above an accepted limit. It protects fluid paths, sterile barriers and device function, and supports compliance with ISO 13485 and the EU MDR.
Which leak test method is best for catheters and tubing?
Flow testing is usually the best fit, as it checks both function and leak detection in one cycle. Pressure decay is also widely used for catheter assemblies and connectors.
How small a leak can be detected?
It depends on the method and part. Air-based methods such as pressure decay and flow testing detect leaks down to fractions of a cc/min on many devices. For smaller leaks, helium tracer gas detection offers far higher sensitivity.
Can leak testing be integrated into an automated production line?
Yes. Compact modules such as the F26 Speed and F67 are designed for automatic and semi-automatic machines, with network connectivity for multi-station lines.
Does ATEQ support medical manufacturers in Denmark, Norway and Finland?
Yes. ATEQ Nordics supports manufacturers across the Nordic region with application testing, engineering, calibration and training.
