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Testing of protective equipment for the medical sector

Cross-company project by TÜV NORD CERT, DMT, Hochfrequenztechnik, TÜV NORD Systems, TÜV NORD Umweltgutachter, TÜV NORD China and TÜV NORD Singapore.

The testing of protective equipment for the medical sector has been playing an important role for various TÜV NORD companies in recent weeks. Following headlines about useless masks, the need for testing is currently greater than ever.

TÜV NORD China

TÜV NORD China test teams in Beijing and Shanghai are working almost around the clock to inspect goods before they are shipped to Germany. This includes checking documents, packaging and the ensuring that the contents of shipments correspond to the listed goods. They also carry out visual, haptic and olfactory tests on the respiratory masks. The Bundesministerium für Gesundheit [translated: Federal Ministry of Health] has thanked our colleagues in China for this enormous effort and the professional handling. Thomas Triller, consul and working in the Economics and Science Department of Deutsches Generalkonsulat [translated: German Consulate General] in Shanghai, visited the inspectors in a warehouse and delivered the message of thanks.

To date, TÜV NORD China has inspected random samples of around 250 million masks and continues to work on preparing protective equipment for delivery to Germany. Once in Germany, the imported goods will be inspected again and tested in a shortened procedure by TÜV NORD CERT and DMT.

TÜV NORD CERT

On behalf of Bundesministerium für Gesundheit (BMG) [translated: Federal Ministry of Health], TÜV NORD CERT has been inspecting personal protective equipment for the medical sector as part of its quality assurance activities since the end of March. In addition to the laboratory tests, tests were carried out at six locations in Germany. At times, up to 80 employees from the most varied areas of the TUV NORD Group provided support, and to date they have tested around 1 billion masks in random samples. Approximately 3,000 deliveries were visually inspected and 2,000 different types of masks were tested in the laboratory at DMT. In an interview with the German medical journal "Ärztezeitung", the BMG expressly praised TÜV NORD's "very good performance and high inspection quality" (6 July 2020). 

"Special thanks go to Ralf Thomsen and the cross-divisional team and expressly to the many other colleagues who made the inspections of the delivered goods and the laboratory tests possible within a very short time", praises Wolfgang Wielpütz, Head of OBS System Certification. "All those involved put personal concerns to the back of their minds and gave their full support - and it was not always easy".

DMT

At the same time DMT also set up a test stand in Essen, Germany, in the Refrigeration & Air Quality Product Testing segment. With the support of TÜV NORD CERT, DMT’s application for recognition of an abridged ZLS test procedure for FFP2/3 masks has been approved by Zentralstelle der Länder für Sicherheitstechnik (ZLS) [translated: Central Office of the Federal States for Safety Technology]. A simplified procedure for the testing of medical masks was jointly agreed with Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) [translated: Federal Institute for Drugs and Medical Devices]. The test has been in place since the beginning of April and was quickly expanded to include a second DMT test stand. To further increase the testing capacity, an additional protective mask test stand was set up at DMT in cooperation with Institut für Energie- und Umwelttechnik e.V. (IUTA)[translated: Institute for Energy and Environmental Technology]. The tests on the three test benches have been running in three shifts (24/7) since Easter. At times up to 55 types of mask were tested per day.

TÜV NORD Singapore

TÜV NORD Singapore also began testing and classifying surgical masks in February 2020. With the support of colleagues from TÜV NORD CERT, specialist competence was built up and links were established with laboratory partners. Within a short period of time, TÜV NORD Singapore won its first orders, thereby supporting, among other things, the supply of charitable organisations in Singapore. Till date they have successfully completed five mask testing assignments. TÜV Singapore is currently in discussions with the government authorities about the virucidal effectiveness of the coated surface against virus strains. In addition, they are in discussions about acute toxicity tests (oral, dermal and inhalation) for coatings/paints according to the international standard ISO 10993. 

Outlook

"The project is a real challenge for all employees at seven different companies - TÜV NORD CERT, DMT, Hochfrequenztechnik, TÜV NORD Systems, TÜV NORD Umweltgutachter, TÜV NORD China and TÜV NORD Singapore", explains Ralf Thomsen, Head of the Medical Device International cluster. "The testing of masks and protective equipment will continue to accompany us in the future, both professionally and in everyday life. In addition to the project with the BMG, which is to continue until December 2021, TÜV NORD CERT has so far received more than 2,000 enquiries about our testing services from industry and other national governments".

Further laboratory testing capacity is also to be established in China. An offer has recently been submitted to BMG for the testing of respiratory protection materials in China.