Leak and Flow Testing of Medical Devices

Rigorous Quality Control for Medical Devices

The EU regulation 2017/745 of the European Parliament and Council concerning medical devices came into force on May 25th 2017. Apart from a few rare exceptions, the medical device regulation shall apply to all devices from May 26th 2020. This will affect - among other things - the classification of these products as well as the requirements to be met.

The new directives are more rigorous and put a special emphasis on risk evaluation. Countless medical devices must fulfill a great number of requirements and work reliably under a wide variety of conditions. Medium-conducting systems must be fluid-tight and the correct flow must be reliably and accurately delivered. Routine testing (100 % EOL tests) is performed in the production line for the purpose of monitoring product quality.

As a manufacturer of leak and flow testers, CETA Testsysteme GmbH brings more than 30 years of experience in the field of industrial testing. The test media used in the process are compressed air and hydrogen. Thousands of CETA test devices are in use all over the world in the production lines of renowned industrial customers, including a great number of devices for testing medical products. Thus, for example, leak testers are used to check the tightness of sensors, pipettes, cannulas, syringes, filtering elements, hose connectors, insulin pumps and valves.

Depending on the application, the process will require CETA leak testers with gauge pressure or differential pressure sensor. The available pressure ranges between -1 and 30 bar. The method frequently used is the differential pressure method, consisting in measuring the pressure difference as compared to a leak-tight reference volume in order to determine the pressure decay due to leakage. This method allows the detection of minimal leak rates of 10-3 mbar*l/s magnitude.

Should the leak be caused by one hole only, this hole would have a diameter of approximately 20 μm at a test pressure of 1 bar. The medical devices needing flow testing are for example membranes, filter elements, pipettes and valves. CETA flow testers cover a range of 3 ml/min to 200 l/min by using various laminar flow elements. Extremely low leak rates down to 10-6 mbar*l/s (corresponding to a hole diameter of approximately 0,1 μm at a test pressure of 1 bar can be detected by hydrogen leak testers.

Since CETA test devices are normally integrated in automated serial production lines, a large number of standard industrial interfaces are available to perform the connection. CETA is certified according to DIN ISO 9001 and the calibration laboratory (D -K-19566) is accredited as DAkkS calibration laboratory (as per DIN EN ISO/IEC 17025) for the measurand pressure up to 60 bar (including for calibration on site).

CETA test devices are quality products and are delivered with a warranty of 3 years with optional extension to 5 years.

Finding the right device for a defined application requires expert knowledge. To find the optimal solution, the customer profits from CETA’ s comprehensive advice based on a long-standing experience in the implementation of inspection tasks and product engineering - in some cases even during the design phase.

CETA can also provide one-stop solutions thanks to their long-standing cooperation with Gaedigk Feinmechanik & Systemtechnik GmbH – one of the leading companies in the field of automation technology for the construction of special machinery. This ranges from appliances with integrated testing technology to semi-automatic assembly lines.