A medical face mask is a medical device, which covers the mouth, the nose, and the chin ensuring protection of the wearer’s breathe, from infective agents of the environment. A medical face mask should fulfill and be certified according to the applicable EU norms.
A safe to wear medical face mask needs to be tested by an accredited laboratory. Also, its sealed package should prohibit its contact with the external environment before use to secure that the face mask does not get in contact with infectious causes.
Wearer’s comfort is determined from materials breathability and the hydrophilic inner layer, which enables the breath’s humidity to evaporate. In addition, good quality components for the nose and ears make the mask’s face adaption soft and comfortable.
Medical Face Masks are constructed with a 3-layer assembly which consists of:
Within EU, all medical devices much comply with Regulation (EU) 2017/745. According to the regulation, medical face masks shall also comply with the requirements of EN 14683:2019+AC “Medical Face Masks – Requirements and Test Methods”.
The standard defines the medical face mask’s structure and performance, especially for the points of Bacterial Filtration, Differential Pressure (which expresses breathability), and Microbial Cleanliness. Type I medical face masks reduce the risk of spread of infected agents especially in epidemic or pandemic periods, while Type II medical face masks are recommended for us by medical personnel in surgical environment or any similar setting.
Medical face masks are categorized in 3 different types based on the performance on the following tests:
|Classification table||Type Ι||Type ΙΙ||Type ΙΙR|
|Bacterial Filtration Efficiency (BFE), %||≥ 95 %||≥ 98 %||≥ 98 %|
|Differential Pressure Delta-P (breathability)||< 40||< 40||< 60|
|Splash resistance (kPa) – synthetic blood||not required||not required||≥ 16,0 %|
|Microbial Cleanliness cfu/g||≤ 30||≤ 30||≤ 30|
Bacterial Filtration Efficiency (BFE)
Differential Pressure (Breathability)
Splash Resistance (synthetic blood)