The European Medical Device Regulation 2017/745/EU (MDR "Medical Device Regulation") came into force on May 26, 2021, after an extended transition period. Among other things, this contains a product reclassification and stricter requirements for manufacturers of medical devices. In addition, special and increased importance is attached to the assessment of risks. It should be noted that all medical devices that are currently approved must be re-certified according to the new requirements
Many medical devices must function reliably under a wide variety of conditions. Media-carrying products (e.g. pipettes, cannulas, catheters, syringes, filter elements, tube connectors, insulin pumps, valves) must be tight against liquid leakage, while other products require tightness against liquid or moisture ingress (such as cameras, endoscopes, sensors, actuators, displays, control elements, packaging). And the correct flow must be ensured reliably and precisely (e.g., for lines, membranes, filter elements, pipettes, valves)
Non-destructive routine testing in the production line (100% end-of-line testing) is used to monitor product quality. When integrating an inline test procedure into the production process, various aspects must be considered:
- Product features (e.g. expansion during pressurisation, internal structure, settling behaviour of internal components, geometry, adaptation)
- Production process (cycle time, process stability requirements, preceding production process)
- Determination of suitable test parameters (leak test: test pressure and permissible leak rate / flow test: test pressure and flow range)
- Test technology (selection of a test device suitable for the test task)
Finding the right test instrument for a defined application requires specific expertise and experience. CETA Testsysteme GmbH has more than 30 years of experience in the implementation of industrial testing tasks, combined with its own product development. CETA advises the customer comprehensively - sometimes even during the design phase - in finding the optimum solution.
With a comprehensive range of CETA test equipment (differential pressure and relative pressure leak testers, hydrogen leak testers, mass flow testers, volumetric flow testers), leak rates down to 10-6 mbar*l/s and flows up to 220 l/min can be detected. Compressed air, nitrogen or hydrogen (forming gas: 5 % hydrogen, 95 % nitrogen) are used as test media.
The CETA test devices are quality products and are supplied with a warranty of 3 years, with the optional extension to 5 years.
CETA is certified according to DIN ISO 9001 and the calibration laboratory (D-K-19566) is accredited as a DAkkS calibration laboratory (according to DIN EN ISO/IEC 17025) for the measurand pressure (also for on-site calibrations). The CETA leak testers are supplied as standard with DAkkS calibration certificate, which is internationally recognised.
Several thousand CETA test devices are in use in production lines at well-known industrial customers worldwide, many of them also in the testing of medical devices.
CETA will be exhibiting at MEDICA 2022, the world's largest medical trade fair, in Düsseldorf from 14.11. - 17.11.2022 (Hall 3, Booth C80).
Exhibitor Data Sheet