Norms and standards for mouth and nose protection and respiratory masks

Depending on the country, different norms and standards apply to mouth and nose protection and respiratory masks.

The following overview shows the most relevant norms and standards relating to the three product categories "Single Use Face Mask", "Mouth and Nose Protection" and "Filtering Face Piece":

Mask TypeStandardsFiltration Effectiveness
Single Use Face MaskChina: YY/T0969BFE: ≥95%
PFE: x

Mouth and Nose Protection

China: YY 0469BFE: ≥95%
PFE: ≥30%
USA:
ASTM F2100
Level 1
BFE: ≥95%
PFE: ≥95%
Level 2
BFE: ≥98%
PFE: ≥98%
Level 3 BFE: ≥98%
PFE: ≥98%
Europe:
EN 14683:2014
Typ I
BFE: ≥95%
PFE: x
Typ II
BFE: ≥98%
PFE: x
Typ IIR
BFE: ≥98%
PFE: x
Filtering Face Piece

USA: NIOSH
(42 CFR 84)
China: GB2626

N95 / KN95
0,3 μm: ≥95%

N99 / KN99
0,3 μm: ≥99%

N100 / KN100
0,3 μm: ≥99,97%

Europe:
EN 149:2009

FFP 1
0,3 μm: ≥80%

FFP2
0,3 μm: ≥94%

FFP3
0,3 μm: ≥95%

Source: Südwesttextil - Verband der Südwestdeutschen Textil- und Bekleidungsindustrie;
VTB - Verband der bayerischen Textil- und Bekleidungsindustrie

Mouth and Nose Protection

A mouth and nose protection, also known as a surgical mask, is mainly intended to protect against droplets from the nasopharynx of the wearer. The wearer himself or herself is only protected against larger splashes by the mask.

The testing and classification of mouth and nose protection products in Europe is based on the measurement of the Bacterial Filtration Efficiency (BFE) and Respiratory Resistance according to DIN EN 14683:2014. In China and the USA, the masks are also tested and classified by their Particle Filtration Efficiency (PFE).

Compared to a filtering face piece, a mouth and nose protection has a lower breathing resistance and often do not fit tightly enough so that breathing past them is possible. mouth and nose protection types marked with an "R" have a higher resistance to liquids and aerosols

Testing according to DIN EN 14683Type IType IIType II R
Bacterial Filtration Efficiency (BFE)≥95%≥98%≥98%
Respiratory Resistance≤ 29,4 Pa/cm2≤ 29,4 Pa/cm2≤ 49,0 Pa/cm2
Resistance to liquid splashesnot requirednot requiredyes

Filtering Face Piece

Filtering Face Pieces (FFP) cover nose and mouth and protect against respirable dust, smoke and liquid mist (aerosol). The protective function of respiratory masks is standardized throughout Europe according to DIN EN 149:2009 and is divided the masks into the protection classes FFP1, FFP2 and FFP3.:

Decisive for the classification is the total leakage of the mask. This results from the filtration efficiency against particles (>0.6 μm) and the leakage between the mask frame and the wearer's face. As the protective effect and thus the tightness increases, so does the breathing resistance of the mask.

ClassProtective function
FFP1FFP1 respiratory masks should only be worn where only non-toxic dusts and respiratory irritants are expected. They are used up to 4 times the occupational exposure limit value and filter at least 80% of airborne particles >0.6 μm.
FFP2FFP2 respiratory masks provide protection against solid and liquid aerosols and airborne infectious agents that are hazardous to health. They are used up to a 10-fold excess of the occupational exposure limit value and filter up to 94% of particles >0.6 μm from the air breathed. According to the common opinion of experts the minimum protection class against virus infections.
FFP3FFP3 respiratory masks offer the highest possible protection against toxic and harmful aerosols and airborne infectious agents within the protection classes for masks of EN149. They are used up to a 30-fold excess of the workplace limit value and filter at least 99.5% of particles >0.6 μm from the air we breathe.

For all masks, a few notes on correct handling should be observed. The Federal Institute for Drugs and Medical Devices (BfArM) has compiled these in a list (available only in German language):
https://www.bfarm.de/SharedDocs/Risikoinformationen/Medizinprodukte/DE/schutzmasken.html