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FFP2 masks must comply with PPE Regulation 2016/425 and EN149:2001+A1:2009 to obtain CE marking.

Sentias - FFP2 Masks with the Highest Quality Standards

At the beginning of the COVID-19 pandemic, there was a lack of everything – including effective and high-quality protective masks. Felix Blaschke and Christian Vorbau, two entrepreneurs, reacted quickly and founded the start-up company Sentias GmbH & Co.KG., which has been producing FFP2 masks in Wuppertal, Germany, since June 2020. Quality is a top priority for the young company, which also received funding from the German Federal Ministry of Energy and Economics. Since April 29, 2021, Sentias FFP2 masks have been certified by TÜV Rheinland Intercert Kft. and are shipped with the imprint “CE 1008”.

Client Sentias GmbH & Co.KG.
IndustryStart-up (production of FFP2 masks)
HeadquarterWuppertal, Germany
EmployeesApprox. 50
ProductFFP2 masks (PPE, category III)
  • Made in Germany (incl. raw materials)
  • Tested for harmful substances
  • Dermatologically tested
Goals and ChallengesEU type examination certificate for FFP2 masks
Applicable Regulations
  • PPE Regulation 2016/425
  • EN149:2001+A1:2009
DeliverablesTest report and EU type examination certificate

Starting Situation and Conditions

The Sentias company has evolved rapidly during the COVID-19 pandemic. As early as March 2020, the two founders started importing protective masks from Asia; something they were able to do in just a few days thanks to their good connections in the producing countries. However, as the worldwide demand grew dramatically over the following months, it became increasingly difficult to import masks of an adequate quality.

This led to the idea to produce the masks themselves. A high quality standard is at the core of the Sentias brand. This is reflected not only in the production location in Germany and the materials used, but also in the thorough and complex internal product tests.

Challenges

Since the beginning of the COVID-19 pandemic, the market for all kinds of protective masks has been subject to strong competition, dominated by Asian manufacturers. The current pricing structure has been the biggest challenge for the company Sentias, which values socially responsible pricing so that high-quality protective masks do not become luxury goods. Therefore, the start-up wants to distinguish itself from the competition with a particularly high quality standard.

The first step was to set up a production facility in Wuppertal, Germany. The young company also sources its raw materials from Germany. These are processed on three machines by around 50 employees, who work in shifts.

Solutions and Deliverables

In order to verify the high product quality, Sentias wanted to have the type examination and CE marking conducted by a trustworthy partner. The testing of the new FFP2 masks was carried out by the experts from TÜV Rheinland. The masks fall under the Personal Protective Equipment Regulation 2016/425 and must also comply with EN149:2001+A1:2009.

"We chose TÜV Rheinland because we find it to be a trustworthy authority. During the certification process, we really appreciated the open dialog, the great accessibility and the close communication with the sales department."

Christian Vorbau, Sentias GmbH & Co.KG.

As part of the required testing, aspects such as the material, packaging, product labels and descriptions, and in particular the filter medium's permeability, breathing resistance and leakage of the masks are closely examined. Since April 2021, Sentias FFP2 masks have been supplied with the "CE 1008" mark from TÜV Rheinland as the Notified Body.

Benefits for Clients

  • During the pandemic, masks with counterfeit test marks repeatedly appeared on the market. With testing and certification by an independent, international test service provider such as TÜV Rheinland, you verify your quality statement.
  • The EU's "New Approach Notified and Designated Organisations" information system has designated TÜV Rheinland InterCert for the certification of particle-filtering masks.
  • Our global reach enables us to test your products quickly and efficiently
  • We have decades of experience in testing Personal Protective Equipment

The CE Marking

Through its status as a Notified Body, TÜV Rheinland is an important point of contact for all companies that manufacture or distribute particle-filtering masks. As an independent testing service provider, we have specialized laboratories all across the world for testing Personal Protective Equipment. After successful certification, manufacturers can affix the CE mark on their products and place them on the European market as Personal Protective Equipment.

The CE mark is followed by a four-digit number indicating the respective testing organization – for example, "1008" for TÜV Rheinland. Buyers should also make sure that the packaging or the product displays the manufacturer's name. The masks must also have an expiration date. This date indicates the minimum period for which the filter performance is guaranteed when the mask is used properly. Finally, the instructions for use must be followed exactly so that the masks can fully develop their protective effect.

The effectiveness of the protection is the focus of product testing: Particle filtering masks (Filtering Face Piece, FFP) are also referred to as FFP1, FFP2 or FFP3 masks, depending on the permeability of the filter. The filtering performance of the mask material is tested based on the European standard DIN EN 149 for protection against particulate pollutants containing aerosols: FFP2 masks, as certified by TÜV Rheinland, must filter at least 94 percent of the aerosols during the test. FFP masks are used for self-protection against droplets and aerosols. Unlike medical face masks, FFP masks are not considered medical devices, but rather Personal Protective Equipment. These products may only be certified by a Notified Body recognized by the European Union (EU). In this case, it is TÜV Rheinland InterCert for the EU.

About TÜV Rheinland

TÜV Rheinland stands for safety and quality in virtually all areas of business and life. Founded almost 150 years ago, the company is one of the world’s leading testing service providers with more than 20,000 employees and annual revenues of 2 billion euros. TÜV Rheinland’s highly qualified experts test technical systems and products around the world, support innovations in technology and business, train people in numerous professions and certify management systems according to international standards. In doing so, the independent experts generate trust in products as well as processes across global value-adding chains and the flow of commodities. Since 2006, TÜV Rheinland has been a member of the United Nations Global Compact to promote sustainability and combat corruption.

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