Leak Testing of Medical Devices

A medical device is any device intended to be used for medical purposes. Manufacturers of medical devices aid patients with their products by helping health care providers diagnose and treat them to overcome sickness or disease, improving their quality of life. To ensure patient safety, medical devices must be proved safe and effective with reasonable assurance. Leak testing of medical devices is one crucial part in the overall process to ensure patient safety.

Which medical devices are leak tested?
Medical devices that are used to transport fluid in or out of a body (i.e. catheters) or are directly implanted inside the human body (i.e. pacemakers or implantable diabetes sensors). Medical devices come in different sizes and often feature complex geometries. Most devices are made out of flexible and elastic silicons or other common polymer-based materials depending on its use.

Leak Testing Services by Pfeiffer Vacuum

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Below are some examples of products where Pfeiffer Vacuum’s solutions can be used for medical device leak testing:

Medical Solutions, Fluid or Blood Bags
Drug Delivery Devices & Pumps
Disposable (Multi-)Lumen Catheters
Balloon Catheters (with/without stent)
Dialysers
Medical Filters

Implanted Cardiac Devices
Respiratory Breathing Tubes/Circuits
Medical Fittings
Medical Sensors
Medical Valves
And many other

With the variety of medical devices comes also a huge range of testing requirements. Not only in regards to parameters like leak rate or test pressure, but also for suitable leak testing methods. While the water tightness of a catheter can be tested in a water bath test or by common air leak test methods, implantable and hermetically sealed medical devices like pacemakers need high sensitivity methods like helium leak testing.

Medical devices also come in different sizes and often feature complex geometries. Hence an important part of a complete leak testing solution for medical devices should include an effective sealing concept. Moreover, most medical devices are based on silicone and other polymer based materials that can affect the leak test strategy. For example, this can have an impact on the applicable test pressure. It could also limit the use of a tracer gas like helium, because of negative impacts from permeation effects.

Finally, since patient safety is of the upmost importance, regulatory conformity is required. This could be guidelines that suggest the use of a certain test method or test strategy. On the other side this could be software requirements like described in the CFR 21 part 11 EU Annex.

Leak testing requirements

Generally speaking there are three main requirements that a leak test method for medical devices should fulfill:

Fast measurement times
High reliability of leak test method
High sensitivity

Pfeiffer Vacuum solutions

All these requirements can be met with our Pfeiffer Vacuum leak testing technologies. For products that need water tightness or a higher sensitivity than pressure decay our Micro-Flow technology can be used. Leak rates down to 10-4 mbar*l/s can be reached with pressure. Moreover, this technology offers fast and reliable leak testing with air with reduced temperature sensitivity compared to other air testing technologies as pressure decay.

For more demanding applications in regards to sensitivity our tracer gas products for helium and hydrogen leak testing are the perfect solution. Especially for hermetically sealed implanted objects, when there is no connection to apply pressure/vacuum, like pacemakers, the helium bombing method is the perfect solution.

Please contact our experts to find the best leak testing solution for your application.