Medical face masks are medical devices and must comply with European standards in order to be safe for use. According to European standard EN 14683: 2019, medical masks are classified into three types: Type I, which has bacteria filtering effectiveness ≥95%, Type II, which has bacteria filtering effectiveness 98%, and Type II, which has bacteria filtering effectiveness ≥ 98% but is also resistant to liquids. Type I surgical mask is considered a consumable medical device and is also used by patients to reduce the risk of infection spreading, especially in epidemics or pandemics. Type II and IIR masks are mainly intended for use by healthcare professionals in operating rooms or other medical procedures with similar requirements. They can be used from 3 to 8 hours according to the manufacturer’s instructions.

The European standard clearly defines the materials for the construction, design, performance requirements (bacterial filtration efficiency, breathability, biocompatibility, etc.) as well as marking, labeling, and proper packaging. The information to be provided by the manufacturer is a) the number of the European Standard EN 14683: 2019 and b) the type of mask as defined by the same standard (I, II or IIR).

More complex respirator masks protect against airborne agents that cause infections, such as pollen, dust, bacteria, and viruses. In Europe, they are categorized as FFP1, FFP2, and FFP3 while in USA are categorized as N, P and R depending on the filtration rate and leakage. The N95 (or FFP2) respirators filter   ≥95% of the airborne bacteria inhaled through it, including viruses. However, not everyone is able to wear a respirator mask due to respiratory or other medical problems that may be exacerbated during breathing, and are addressed exclusively to specialized or medical staff. Before using a respirator, health professionals should be aware of how to apply it properly and have undergone a medical evaluation to make sure they are able to wear it safely.

There are still many types of masks on the market that are intended for use by workers who need protection from dust, particles, chemicals, etc. but they are not medical devices and should not be considered as such. These masks have different standards and are in no way intended for use by medical staff, patients or the public.

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