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Certification and quality assurance

An innovative manufacturing process is required to produce highly filtering and thus effective respiratory protection masks. A CE certification is required for distribution. This means that an independent, state-accredited body checks whether a mask actually fulfills the requirements set by the standard and guaranteed by the manufacturer.

In addition to CE certification, quality assurance during the production process is therefore of decisive importance. Only continuous, complete and traceable monitoring of the manufacturing process and the materials used can ensure that each individual mask protects the wearer.

The Atemious-pro respirators from Univent Medical are manufactured in Germany on state-of-the-art production facilities and strictly controlled in the best “Made in Germany” sense.

The comprehensive control of all materials used guarantees that the applicable standards are not only met, but significantly exceeded.

Every Atemious-pro respirator exceeds the normative requirements for filter performance! At the same time the breathing resistance is very low. It is less than 60% of the permitted value. The tests for the release of potentially harmful particles are also unambiguous: thanks to the sophisticated manufacturing process, the so-called tear-out rate is 0.0 percent.

IMPORTANT NOTE: MANY IMPORTED RESPIRATORS DO NOT OFFER THE SAFETY OF THE ATEMIOUS PRO RESPIRATOR!

At the request of the Bündnis90/Die Grünen parliamentary group in the Bundestag, the Federal Government provides detailed information in BT-Drucksache 19/21798. It states: “As of 12 August 2020, more than 5,400 test procedures using checklist testing and more than 3,000 laboratory tests have now been carried out. 20 percent of the masks tested did not pass the checklist test. Only those masks that passed the checklist test were subjected to a laboratory test. Of the masks tested in the laboratory (almost exclusively particle-filtering half masks), 40 percent did not pass. (…) In the laboratory tests, there were deficiencies in 790 cases in the breathing resistance and in 543 cases in the permeability test. Specifically, a number of manufacturers whose respirators could not be placed on the market have been designated: masks manufactured by Daddybaby; masks manufactured by Xin Neng Dian CTT Co Ltd and Anhui Hongqing Protective Equipment (Hong Quing); masks manufactured by Guangzhou Runjia; masks manufactured by Wintex Apparel. You can find the complete Bundestag document here.

Dr. Maximilian Weiß, CEO of Palas GmbH in Karlsruhe, also issues a warning against insufficiently protective masks. Among other things, his company is a leader in the development and manufacture of test equipment for testing filtering respirators. It now offers mask testing as a service. The much discussed contribution of the consumer magazine “WISO” on ZDF was based on measurements of the Palas GmbH. “Since we started offering mask tests as a service, we have performed well over a thousand measurements. Unfortunately, our test results are the same as those for the WISO editorial office. Numerous FFP2 masks are of insufficient quality and there are isolated masks of extremely poor quality”. His advice: “When making your choice, prefer to buy protective masks from German manufacturers. They take quality assurance very seriously and deliver good quality. Make sure that an FFP2 mask is fully and correctly CE-marked”. The WISO contribution of 26.10.2020 can be found here

Please find the following information on the following pages:

Information on the specific certification of the Atemious pro respirators by Univent Medical

You can find the EU regulation as pdf here.

Information on the regulatory basis for the certification of respiratory masks in Germany:

The basis for the certification of respiratory masks is the EU/2016/425 regulation on personal protective equipment. As regards definition, the purpose of respiratory masks within the meaning of the Regulation is to protect the wearer of the mask. The basic principle is that “the essential health and safety requirements shall be interpreted and applied in such a way as to take account of the state of the art and practice at the time of design and manufacture and of technical and economic considerations which are taken into account to a large extent

the protection of health and safety”, the Regulation states. Die einzelnen Schritte und Anforderungen der Zertifizierung sind in der Verordnung und zahlreichen Anhängen genauestens festgelegt. In the language of the authorities, certification is referred to as a “conformity assessment procedure”. You can find the EU regulation as pdf here.

The conformity assessment procedure:

Depending on the risk classification of the corresponding product (Class I – III), a conformity assessment procedure is chosen according to the regulation (see graph). For filtering respirators, risk class III applies, so conformity assessment is usually based on a type test. The detailed requirements for this are described in module B (Annex V), the requirements for internal production control in Annex VII. Due to the corona pandemic with a strong increase in demand for respiratory masks and other protective equipment, it was possible for a limited time to place protective equipment on the market by means of an accelerated approval procedure (CPA). This procedure was regulated in the so-called “Medical Need Versorgungssicherstellungsverordnung” of 25 May 2020. It is precisely these accelerations that have been exploited by some suppliers, which is why it is so important to check the quality of respirators carefully.

In the case of personal protective equipment (PPE) of category III, a notified body must be involved for the EU type examination (according to module B of the EU regulation) and for monitoring due to the high risk. Voluntary test marks, such as the GS mark, can only be applied to category I and II PPE after appropriate testing and certification. For category III PPE, the contents of the certification procedures for obtaining the CE mark or the GS mark are comparable. Therefore the GS mark is not used for category III products and thus filtering respirators.

Approval:

For the approval of the corresponding product, an application must first be submitted to a notified body for the respective product category. After positive evaluation of the application, both the complete technical product documentation is checked and a product test is carried out, in which not only compliance with the normative requirements (EN 149 for breathing masks) but also the accompanying information such as packaging, printing, instructions for use etc. is checked. Due to the high normative product-specific requirements (e.g. for filter performance or breathing resistance), only a few masks pass the type test and are thus approved for CE marking as proof of compliance with the so-called “essential requirements”.

Only “notified bodies” may test protective masks. Even before the Corona situation, the range of Notified Bodies for the certification of PPE was very limited. The Corona crisis has further aggravated this situation, so that only very few Notified Bodies in the EU accept applications for a conformity assessment procedure at all. In total there are only about 30 Notified Bodies for the EU, most of which are located in EU countries. In addition, there are Notified Bodies in Turkey, Norway and Switzerland, which are authorised to carry out conformity assessment procedures and issue the corresponding confirmations. All these providers are subject to identical monitoring and identical requirements. A respiratory protective mask bearing the CE marking and the identification number of the relevant Notified Body can be assumed to actually meet the relevant essential requirements of the PPE Regulation 2016/425/EU. The statement that only DEKRA or TÜV are allowed to carry out corresponding tests is demonstrably incorrect, as this is basically a European harmonised procedure and both the market for masks and the – if you like – market for certification services are European in character.

Information on the specific certification of the Atemious pro respirators from Univent Medical:

In spring 2020, Univent Medical GmbH, together with a mechanical engineering company from Switzerland, set up eight production lines for the manufacture of respiratory masks. The first certification was based on the “Medizinischer Bedarf Versorgungssicherstellungsverordnung”, which came into force on 25 May. In a letter dated 17 July 2020, the market surveillance authority of Baden-Württemberg, located at the Regional Council in Tübingen, informed us that the mask “may be made available for purposes of infection protection”. You can find the official document here.

This was preceded by an evaluation procedure based on a test cycle published by the Central Office of the Länder for Safety Engineering (ZLS). TÜV NORD CERT GmbH in Essen has been appointed as the test centre. The result of the test conducted from 8 to 12 July and published on 14 July 2020 shows the extremely high technical standard of the Atemious pro respirator. Tests were carried out according to the FFP 2 standard with aerosols from sodium chloride (NaCl) as well as with aerosols from paraffin oil.

The three masks randomly selected from a pack of ten achieved values of 99.07%, 99.42% and 99.22% in the NaCl test of filter performance. All three values are thus well above the requirements of FFP 2 masks (94% filter performance) and even in the range of FFP 3 masks (requirement 98% filter performance). At the same time, low values for breathing resistance were measured: 170 Pascal at an exhalation volume of 160 litres/minute and 109 Pascal at an exhalation volume of 95 litres/minute. The limit value is always 300 Pascal.

When testing with paraffin oil – this aerosol is used in tests according to American and Japanese law – the Atemious pro also convinced. Filter values of 99.2%, 99.64% and 99.73% were measured. The breathing resistance was 170 and 109 Pascal respectively, which underlines the consistent quality of the masks. The two test reports can be found here.

It was thus established that the product meets the essential requirements of the above-mentioned EU Regulation 2016/425

offers a comparable level of health and safety. However, as the successfully passed assessment procedure does not correspond to a full conformity assessment procedure, the Market Surveillance Authority prohibited the marking with the CE number – as for any other test according to the Medical Needs Versorgungssicherstellungsverordnung: “For this reason, no CE marking or other misleading markings (e.g. FFP or references to DIN EN 149) may be affixed to these products”, the letter states. We would therefore like to emphasise that all masks delivered by Univent Medical GmbH meet the high requirements, even if masks with an early production date do not (may not) bear the CE mark.

Certification according to conformity assessment procedures could be carried out shortly afterwards. While no testing capacities were available in Germany in the short and medium term, with the Notified Body “Universal Certification” in Istanbul an accredited institute could be found which fully complies with international standards and has an impeccable reputation. The extensive tests carried out with aerosols made of sodium chloride as well as with paraffin oil confirmed the values determined by TÜV Nord: All nine masks per test aerosol were above 99% filter performance. The values for breathing resistance also correspond to the values measured previously, with an average resistance of 42 Pascal at an exhalation volume of 30 litres/minute and 109 Pascal at 95 litres/minute. You can find the test protocol here.

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