We manufacture a large number of FFP2 masks every day. Not only do our automatic systems (manufacturing & test bench) support us here, but also our well-thought-out processes. When manufacturing FFP2 masks, there are a few things to consider in order to ensure protection for our customers by using our quality products.
At the same time, as with all consumer goods, there are of course things to consider when using our FFP2 masks. In this article, we would like to provide comprehensive information about the use as well as quality features and possibilities for testing any masks on the part of our customers or end-users.
All features at a glance
It is critical that protective products, such as FFP2 masks, are thoroughly inspected before being worn in order to safely filter particles and protect our respiratory tract from harmful substances. Inadequate or insufficient protection cannot guarantee complete filtration. As a result, we'd like to define the general standard for particle filtering face masks (FFP = Filtering Face Piece). Extreme caution is required if even one feature is missing.
The following information must be clearly declared on each product (on the mask itself) as required by law:
Topline(s): manufacturer name/identity and product designation
Below: number and year of publication of the European standard (e.g. of EN 149)
Below: protection class FFP1, FFP2 or FFP3, followed by a mandatory suffix (NR = non-reusable after one shift - or - R = reusable); possibly with the optional suffix D for high dust exposure
At the bottom: CE marking: This is always followed by the 4-digit code of the notified body responsible for monitoring. This number can even be used to find out whether this test center is approved. The "notified bodies" in Europe are listed in the NANDO database of the EU Commission. For respirators, the search under "Products" must be narrowed down to "Devices for protecting the respiratory tract" and under "Processes" to "Supervised product controls at irregular intervals/Annex VII". These search criteria provide an up-to-date list of European Notified Bodies responsible for monitoring respiratory protective devices.
If these four markings are not present on the mask, or if the 4-digit code comes from a non-approved testing agency, it is not an FFP respirator that has received non-compliant testing.
In addition to the markings on the FFP mask itself, documents should also be enclosed:
Instructions for use (instruction booklet) in the language of the country where the product is sold (e.g. in German for the German market)
Declaration of conformity by the manufacturer (available either in the instructions for use or on the internet via a link in the instructions for use)
Handling an FFP mask
Caution is also advised when tips on how to use protective products are provided on the Internet by sources with no medical background. Supposedly well-intentioned advice on social media is not always beneficial to users who act on it.
For optimal protection, FFP2 masks should be worn for a maximum of 8 hours.
It is strongly discouraged to "refresh" FFP2 masks in the oven. Such a thing is not possible.
When is an FFP2 mask defective?
The problem of defective or counterfeit breathing masks is essentially limited to particle-filtering half masks intended to reliably protect the wearer from exposure to hazardous substances or pathogens. These masks, therefore, represent personal protective equipment (PPE).
FFP masks must be checked for compliance with the requirements of the EU PPE regulation before they can be placed on the European market. For this purpose, the European standard EN 149, Respiratory protective devices - Filtering half-masks for protection against particles - Requirements, testing, marking (EN 149:2001+A1:2009) is applied. If the performance of the product has not been tested against the test standard by an independent testing agency, certification is not possible and the manufacturer cannot affix the CE mark to their product. If such a mask is nevertheless advertised and marketed as an FFP mask, it must be assumed that the performance requirements are not met, i.e. the mask does not offer reliable protection and must therefore be classified as defective.
It is not known how many defective or even counterfeit products are currently on the market. The situation is very complex as a fake certificate does not necessarily mean that the products themselves are defective and vice versa. Even an expert cannot tell with absolute certainty whether a product is counterfeit without testing it in a lab. Therefore, as a user, it is all the more important to check the masks in detail according to the four points mentioned above.
Protection by high-quality masks
People who want to protect themselves against infectious agents can do so not only with a particle-filtering half mask of protection class FFP2 or FFP3, but also with a rubber or silicone half or full mask with one or, in the case of double filter masks, two suitable exchangeable class P2 or P3 particle filters. In the event of specific occupational hazards, FFP3 masks or half or full masks with P3 filters are used.
Are there other indicators for the quality of FFP masks?
There is still an EU type-examination certificate for masks. The manufacturer must be able to provide a valid certificate (EU Type Examination Certificate) upon request. This certificate is issued by an independent body. Some notified bodies have published information on the certificates they issue in a database. Valid IFA certificates can be researched in the DGUV Test certificate database, provided the manufacturer has agreed to the publication of this information there.
An absolutely clear statement and certainty as to whether the EU type-examination certificate for the mask is genuine can only be given by the issuing bodies themselves. For its part, the EU Commission gives a good indication of whether the test center specified on the certificate actually exists and is authorized to carry out the certification of respiratory protective devices in the NANDO database.
In this case, the search under “Procedure” (=procedure) must go to “EU type-examination / Annex V” (=EU-Type Examination/Annex V) and under “Products (=Products) to “Equipment providing respiratory system protection” ( =devices to protect the airways). These search criteria always provide the current list of European notified bodies for the type examination of respiratory protection products. In this way, you can quickly determine whether further testing is worthwhile.