Leak and Flow Testing of Medical Devices? Rigorous Quality Control for Medical Devices

ID: 1553178
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(PresseBox) - 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 fulfil 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

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

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.

CETA and Gaedigk will exhibit jointly at the COMPAMED Trade Fair from November

18th - 21st, 2019 in D

(hall 8a, stand L25).

CETA takes part at the ?3. Branchentreff-L

CETA exhibits at the Control from May 05th - 08th, 2020 in Stuttgart

CETA Events 2019 - 2020

Solution Partner for industrial Leak Testing and Flow Measurement

The company CETA Testsysteme GmbH was founded in 1988 and is now existing more than 30 years. We are a manufacturer of physical measurement devices for leak testing and flow measurement. Compressed air and hydrogen are used as test media. These testing procedures can be integrated in the production line with high process reliability.

The test devices ("Made in Germany") are the company''s own developments and the components and accessories (e.g. calibration standards) are manufactured in-house. This ensures that the high quality requirements for the internal modules are met right from the start.

Due to different test device technologies and a wide scope of pressure and measurement ranges nearly every test requirement can be fulfilled. An integrated control of the correct test device function guarantees a high standard of process reliability. The scope of products also includes semi-automatic test stands. The test devices are used by the customers for quality assurance, quality control and production assurance. The customers come mostly from the fields of automotive industry, medical technology, heating and air-conditioning industry, fittings and household appliances industry, packaging industry and E-Mobility.

The company is certified according to DIN ISO 9001 and won the quality award NRW in the category Industry. The calibration laboratory has been accredited 2004 as DKD calibration laboratory and 2014 as DAkkS calibration laboratory by the Deutsche Akkreditierungsstelle (DAkkS) - as follower of DKD. DAkkS calibration (in accordance with the standard DIN EN ISO 17025) complies with the requirements of the ISO / TS 16949 standard, valid in the automotive industry. CETA Testsysteme GmbH is the first German manufacturer of leak-testers whose devices are serially supplied with DKD/DAkkS calibration since 2004.

Since 2012 CETA has been certified by "an outstanding credit rating".

The wide range of services includes consulting, feasibility analysis, commissioning, training, maintenance and calibration.

With cooperation partners in China, France, India, Indonesia, Korea, Mexico, Poland, Portugal, Singapore, Spain, Thailand, the Czech Republic, Turkey and Hungary and with thousands of test devices in use all over the world, CETA Testsysteme GmbH presents itself as a competent solution partner for industrial leak testing and flow measurement.



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Solution Partner for industrial Leak Testing and Flow MeasurementThe company CETA Testsysteme GmbH was founded in 1988 and is now existing more than 30 years. We are a manufacturer of physical measurement devices for leak testing and flow measurement. Compressed air and hydrogen are used as test media. These testing procedures can be integrated in the production line with high process reliability.The test devices ("Made in Germany") are the company''s own developments and the components and accessories (e.g. calibration standards) are manufactured in-house. This ensures that the high quality requirements for the internal modules are met right from the start.Due to different test device technologies and a wide scope of pressure and measurement ranges nearly every test requirement can be fulfilled. An integrated control of the correct test device function guarantees a high standard of process reliability. The scope of products also includes semi-automatic test stands. The test devices are used by the customers for quality assurance, quality control and production assurance. The customers come mostly from the fields of automotive industry, medical technology, heating and air-conditioning industry, fittings and household appliances industry, packaging industry and E-Mobility.The company is certified according to DIN ISO 9001 and won the quality award NRW in the category Industry. The calibration laboratory has been accredited 2004 as DKD calibration laboratory and 2014 as DAkkS calibration laboratory by the Deutsche Akkreditierungsstelle (DAkkS) - as follower of DKD. DAkkS calibration (in accordance with the standard DIN EN ISO 17025) complies with the requirements of the ISO / TS 16949 standard, validin the automotive industry. CETA Testsysteme GmbH is the first German manufacturer of leak-testers whose devices are serially supplied with DKD/DAkkS calibration since 2004.Since 2012 CETA has been certified by "an outstanding credit rating".The wide range of services includes consulting, feasibility analysis, commissioning, training, maintenance and calibration.With cooperation partners in China, France, India, Indonesia, Korea, Mexico, Poland, Portugal, Singapore, Spain, Thailand, the Czech Republic, Turkey and Hungary and with thousands of test devices in use all over the world, CETA Testsysteme GmbH presents itself as a competent solution partner for industrial leak testing and flow measurement.

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Date: 10/17/2019 - 09:00
Language: English
News-ID 1553178
Character count: 3557
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Firma: CETA Testsysteme GmbH
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