Testing, certification and CE marking of FFP2 masks
Where can manufacturers and importers have their FFP2 respirators certified? And what can distributors do to check the quality of FFP2 mask shipments?
Since the outbreak of the COVID-19 pandemic, global demand for personal protective equipment (PPE) to protect against the SARS-CoV-2 coronavirus has exploded. Among the most important items of equipment are filtering half masks, which are designed to protect the wearer from inhaling fine liquid particles that can transmit the virus. The term "FFP mask" is derived from the term "filtering face piece". Depending on the performance of their built-in filter, FFP masks are divided into FFP1, FFP2 and FFP3 masks. But what requirements must be met before you as a manufacturer or importer can circulate an FFP2 mask in Europe?
Testing of FFP2 masks according to standard EN 149
The European EN standard according to which FFP2 masks must be tested before they can be put into circulation is called EN 149:2001, in short EN 149 ("Respiratory protective devices - Filtering half masks for protection against particles"). This standard defines various laboratory tests that FFP mask test samples must undergo. These include, for example, tests of leakage and breathing resistance. One of the most important and demanding EN 149 tests is the test of filter permeability. Using two different aerosols (NaCl and paraffin oil), it determines whether the mask retains over 99% of aerosol particles, over 94% or over 80%. Depending on the filter performance measured, the FFP mask is then classified as an FFP3, FFP2 or FFP1 mask. Respirators with lower filtering performance do not meet the requirements of the EN 149 standard. In China, another standard for filtering half masks is relevant: GB 2626-2006. The requirements defined therein are similar to those of EN 149, but differ from the European standard in some details.
How to find a testing laboratory for EN 149
Both in Europe and on other continents, there are accredited testing laboratories that have the EN 149 standard in their scope of accreditation. This means that an accreditation body has confirmed that these labs have the capability to perform testing in accordance with the standard. Examples of accreditation bodies are DAkkS (Deutsche Akkreditierungsstelle) in Germany, DANAK (Den Danske Akkrediteringsfond) in Denmark, TÜRKAK (Türk Akreditasyon Kurumu) in Turkey or CNAS (China National Accreditation Service for Conformity Assessment) in China. Whether a laboratory is accredited for EN 149 can be found in the annex of its accreditation certificate. This is usually also available in the accreditation database of the respective accreditation body. To find a testing laboratory accredited for EN 149 with currently available testing capacities, a free request via the testxchange platform is usually the easiest way.
How to find a Notified Body for FFP2 masks
Since FFP2 masks are Category III PPE, a so-called Notified Body of the EU must be involved in the conformity assessment procedure in accordance with PPE Regulation (EU) 2016/425. This body examines the technical documentation and the EN 149 test report of an FFP mask and then issues an EU type examination certificate. Each Notified Body has a four-digit identification number which must be affixed to the successfully tested FFP2 respirator in addition to the CE marking. It does not matter in which country the body is based. What is important is that it is a Notified Body that is qualified to test PPE, especially PPE for respiratory protection. The European Commission maintains a database on this called NANDO (New Approach Notified and Designated Organisations). If you need a Notified Body for your FFP2 masks, it's best to submit a free request on testxchange to get a quote without wasting time.
Manufacturers and importers of FFP2 masks
There are basically two types of companies that market FFP2 respirators in the European Union: Manufacturers or distributors such as importers, who source their goods from abroad in order to market them themselves in Europe. In either case, the person placing the FFP2 mask product on the market must undergo a conformity assessment procedure and draw up a declaration of conformity. Important prerequisites for this are successful testing in accordance with standard EN 149 and the acquisition of an EU type examination certificate as described above. You can easily obtain a solution for both on testxchange.
For distributors who do not place supplied FFP2 masks on the market themselves, but merely wish to sell them, it is also advised to check the quality of the masks. One good way to do this is to have the permeability of the filter medium tested. This way, it can be determined relatively inexpensively whether the filter class FFP2 is actually achieved by the respiratory protection masks received. Such a filter test can also be requested via testxchange.