An FFP2 mask is a filtering facepiece respirator (FFP). The number “2” indicates the specific level of protection standardized across Europe. These respirators cover the nose, mouth, and chin, creating a close seal to protect the wearer from inhaling hazardous airborne particles, including fine dust, smoke, and liquid aerosols. While originally developed for occupational safety, FFP2 masks gained widespread public recognition during the COVID-19 pandemic due to their effectiveness in filtering microscopic viral particles. Their use became mandatory in many public spaces across Europe to reduce the community spread of airborne viruses.
Understanding FFP2 Certification Requirements
The protective capability of an FFP2 mask is strictly governed by the European standard EN 149:2001+A1:2009. This technical regulation dictates the minimum performance criteria that a mask must meet to be certified and carry the FFP2 designation.
The primary requirement is filtration efficiency, which mandates that the mask material must filter at least 94% of airborne particles. This filtration test typically uses test aerosols composed of sodium chloride for non-oily particles and paraffin oil for oily particles, with particle sizes generally around 0.3 microns.
Another element is the total inward leakage (TIL), which measures the amount of aerosol entering the mask through the filter material and any gaps in the face seal. To pass certification, the maximum allowable TIL rate is 8%. This leakage requirement is tested on human subjects performing various movements to simulate real-world use, ensuring the device maintains its seal under dynamic conditions.
The EN 149 standard also includes assessments for breathing resistance and mechanical strength. Manufacturers must display the standard and classification, such as “EN 149 FFP2,” along with the CE mark and the four-digit number of the Notified Body that certified the product.
Comparing FFP2 to International Equivalents
FFP2 masks exist within a global framework of respiratory protection standards, often leading to confusion with equivalents like the U.S. N95 and the Chinese KN95 designations. While all three respirator types are designed to achieve a similar level of high filtration, they are certified under different national and regional bodies using distinct testing protocols.
The N95 standard is regulated by the U.S. National Institute for Occupational Safety and Health (NIOSH), requiring a minimum filtration of 95% of airborne particles. The Chinese KN95 standard (GB2626-2006) also mandates 95% efficiency. Although the FFP2 requires 94% filtration, this slight difference is considered negligible for most public health and non-industrial applications.
A primary distinction lies in the testing requirements. The European FFP2 standard requires testing against both liquid (paraffin oil) and solid (sodium chloride) aerosols. In contrast, the N95 standard only requires testing against solid particles.
The standards also differ in their maximum allowed breathing resistance and inward leakage requirements. Despite these technical variations in certification, health authorities worldwide often consider FFP2, N95, and KN95 respirators to be functionally similar for filtering non-oil-based particles, such as bioaerosols like viruses.
Practical Guide to Achieving a Proper Seal
The high filtration efficiency of an FFP2 mask is only achieved when the respirator forms a tight seal against the wearer’s face. Leakage around the edges allows unfiltered air to bypass the material, significantly reducing the overall protection factor.
To ensure a secure fit, the wearer must first position the mask correctly, placing the bottom beneath the chin and the top across the bridge of the nose. The straps should be positioned to hold the mask firmly in place, typically with one strap around the back of the neck and the other on the crown of the head. Next, the metal nose clip must be molded tightly around the nose using two fingers to prevent air leakage or fogging of eyewear.
A user seal check is required every time the mask is donned to confirm the seal. This can be done using positive or negative pressure techniques.
Positive Pressure Check
For a positive pressure check, cover the mask with your hands and exhale gently. A successful check means the mask balloons slightly with no air escaping the edges.
Negative Pressure Check
For a negative pressure check, cover the filter area and inhale sharply, which should cause the mask to collapse slightly inward.
A compromise to the seal is common with the presence of facial hair, as even a small amount of stubble can prevent the tight contact necessary for maximum protection.
The Role of Valves in FFP2 Masks
Some FFP2 respirators are manufactured with a small, one-way exhalation valve, typically located on the front of the mask. The primary function of this valve is to improve wearer comfort, especially during long periods of use or heavy physical exertion. The valve opens automatically upon exhalation, allowing warm, moist air to escape directly and unfiltered. This mechanism reduces heat and moisture buildup, making breathing easier.
However, the presence of an exhalation valve introduces a significant drawback regarding public health and source control. While the filter material protects the wearer on inhalation, the valve does not filter the air expelled during exhalation.
Consequently, if the wearer is infected, their exhaled air, including viral particles, is released into the surrounding environment without filtration, offering no protection to others. For this reason, valved FFP2 masks are often prohibited in settings where source control is required, such as hospitals or public spaces during a pandemic. In these environments, only non-valved FFP2 respirators, which filter both inhaled and exhaled air, are recommended.