fbpx

Guide Mask old

1. What defines a medical face mask?

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.

2. What makes a medical face mask safe and comfortable to wear?

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.

3. How a medical face mask is constructed?

Medical Face Masks are constructed with a 3-layer assembly which consists of:

3

LAYER
ASSEMBLY

1. Outer Layer

Hydrophobic polypropylene layer. This is the first layer to contact an infected agent or droplet. Due to its hydrophobic properties it prohibits the absorbance and infiltration of the infected droplet(s).

2. Inner Layer

Hydrophilic soft-touch polypropylene layer for comfortable contact with the skin. Its hydrophilic properties hinder the development of humidity and vapor and allow better evacuation of warm air.

3. Middle Layer (filtration function)

Polypropylene layer made with melt-blown technique. This is the most critical layer against any infected agent. Its porous structure does not allow infected agents to pass through while at the same time it ensures adequate breathability.

4. Which is the relevant European norm?

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”.

5. Which are the requirements of EN 14683:2019+AC?

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.

6. What tests determine the medical face mask’s type?

Medical face masks are categorized in 3 different types based on the performance on the following tests:

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 n/a n/a ≥ 16,0 %
Microbial Cleanliness cfu/g ≤ 30 ≤ 30 ≤ 30

3

KEY
TESTS

Bacterial Filtration Efficiency (BFE)

Differential Pressure (Breathability)

Splash Resistance (synthetic blood)