EU type examination certificate of the FFP2 masks from EPG Pausa
As a result of the COVID-19 pandemic, the core business of many industries continues to be severely affected. However, many medium-sized companies have reacted flexibly to the new conditions and adapted their production to the circumstances. This is also the case with EPG Pausa GmbH from Stolfig Group. The company started the production of FFP2 masks at the Eichelhardt site and was able to conclude a major contract with the German Federal Government and the state of Rhineland-Palatinate in December 2020. The basis for this success was the EU type examination certification of the products by TÜV Rheinland Intercert Kft.
Initial situation and requirements
The Stolfig Group is a development partner of the automotive industry and a first-tier supplier (Tier One). The first wave of the pandemic had already severely affected the order situation, freeing up production capacity.. After the German Federal Government also called on local producers to support them in fighting the pandemic, the Stolfig Group seized the opportunity to build up another mainstay during the crisis.
|Industry||Supplier of tools and components
(e.g. for the automotive industry)
|Client||EPG Pausa GmbH|
|Time frame||12/2020 until 01/2021|
|Goal and Challenges||EU type examination certificate for FFP2 masks|
|Applicable Regulations||- PPE Regulation 2016/425 |
|Deliverables||Test report and EU type examination certificate|
The changeover to a textile product, of course, presented the automotive supplier with a number of challenges. EPG Pausa first had to find suitable production machines, suppliers for the basic materials and qualified staff.
"TÜV Rheinland is an excellent partner in our opinion. The collaboration was highly professional and the communication was always fast and courteous. Despite the holidays at the turn of the year, the certification was driven forward and the audits were conducted at record time in international collaboration."Wei Hong; Managing Director of EPG Pausa GmbH
Certification was also more time-consuming than initially anticipated, as FFP2 masks fall under the Personal Protective Equipment Regulation 2016/425 and must also comply with EN149:2001+A1:2009. In partnership with TÜV Rheinland, everything finally went smoothly and quickly, as Managing Director Wei Hong confirmed. The company is now occupied with the distribution and production of larger margins of their new protective masks.
Meanwhile, EPG Pausa is already working on masks for children. Their development must be based on the specific dimensions of children, so that the masks ultimately meet the requirements for safety and wearing comfort. TÜV Rheinland will also carry out the testing of these products.
Solution and results
TÜV Rheinland has tested the masks of EPG Pausa GmbH according to the regulation 2016/425 for Personal Protective Equipment as well as the standard EN149: 2001 +A1: 2009 and was subsequently able to issue the corresponding EU type examination certificate. Now, the company can attach the CE marking to its FFP masks and offer them as Personal Protective Equipment on the European market.
TÜV Rheinland experts carried out the testing of the new FFP2 masks in the company’s own specialized laboratories. As part of the required tests, the material, packaging, product labels and descriptions and, in particular, the filter medium permeability, breathing resistance and leakage of the masks are checked in detail.
The focus is on the effectiveness of the protection: 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 against the European standard DIN EN 149 for protection against particulate pollutants containing aerosols: FFP2 masks, as TÜV Rheinland has now certified, must filter at least 94 percent of the aerosols in the test. FFP masks are used for self-protection against droplets and aerosols. Unlike medical face masks, such masks are not considered medical devices, but personal protective equipment. Such products may only be certified by a notified body recognized by the European Union (EU). In this case, this is TÜV Rheinland InterCert for the EU.
Benefits for the Client
- During the pandemic, masks with forged certification marks have repeatedly come onto the market. TÜV Rheinland is an internationally renowned testing service provider and a strong partner for your company.
- The EU's "New Approach Notified and Designated Organisations" has designated TÜV Rheinland InterCert for the certification of particle-filtering masks
- By means of our international network of experts and test laboratories, we enable you to test your products quickly and efficiently
- We have decades of experience in testing Personal Protective Equipment
The CE marking
Thanks to its status as a notified body in TÜV Rheinland’s global network of laboratories, the independent testing service provider is an important point of contact for all companies that manufacture or distribute particle-filtering masks. In this context, TÜV Rheinland has specialized laboratories internationally for testing personal protective equipment. After successful certification, manufacturers can CE mark their products and place them on the European market as personal protective equipment. For certification by the experts of the international testing service provider, the products must comply with the requirements of the authoritative Personal Protective Equipment Regulation 2016/425.
With the CE mark, producers themselves declare that their product, in this case respirators, meets all EU legal requirements. A four-digit number indicating the respective testing organization – for example, “1008” in the case of TÜV Rheinland, follows the CE mark. Buyers should also make sure, among other things, that there is a manufacturer's label on the packaging or product. The masks must also have an expiration date. This date indicates the minimum period of time for which the filter performance is ensured when used properly. Finally, the instructions for use must be followed exactly so that the mask can develop its protective effect in an optimal way.
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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