What is a respirator?

A respirator is a tight-fitting filtering facepiece. It is designed to achieve a very close facial fit and very efficient filtration of airborne particles, including dust particles and infectious agents, gases, or vapors. Wearer’s nose and mouth will be at least covered by the edges of the respirator in a tight seal. This gives good breathability to wearers as the facepiece does not collapse against the mouth.

Respirator is categorized into four types: particulate respirator, “gas mask”, airline respirator and self-contained breathing apparatus. Particulate respirator is most commonly used for COVID-19 prevention as it intends to filter out airborne particles, the category can be further divided into six types as table below:

EN 149 ClassNIOSH 42 CFR 84 ClassParticle FiltrationTypical Use
FFP1  Protect against low levels of dust, as well as solid and liquid aerosols. Dust Masks are suitable for hand sanding, drilling, and cutting
FFP2 >=94% Usually disposable and may be used in construction and by healthcare professionals against influenza viruses.
 N95/R95/P95 >=95%Minimal level of protection approved for medical use
FFP3N99/P99>=99%Suitable for handling hazardous powders, such as those found in the pharmaceutical industry
 >N100/P100  Protect workers from exposure to dust, fumes and hazardous mists. They also provide protection against contagious disease
Medical UseFor surgical situations. Additional testing such as bacterial filtration test and fluid resistance test under EN 14683 or ASTM F2100 required.

Similar to medical masks, respirators that are designed to prevent transmission of disease are subject to strict regulatory standards in different countries before being made commercially available.

Regulatory Compliance requirements in different markets:

Market-Specific Regulatory Compliance
CountryPrimary RegulationPerformance StandardClassificationRequirement
Australia AS/NZS 1715:2009 AS/NZS 1716:2012 P3 ≥99.95%
P2 ≥94%
P1 ≥80%
Brazil Fundacentro CDU 614.894 ABNT/NBR 13698:2011 PFF3 ≥99%
PFF2 ≥94%
PFF1 ≥80%
Canada - - N95 Non-oil aerosol ≥95%
N99 Non-oil aerosol ≥99%
N100 Non-oil aerosol ≥99.7%
R95 Oil aerosol ≥95%
R99 Oil aerosol ≥99%
R100 Oil aerosol ≥99.7%
P95 Oil aerosol ≥95%
P99 Oil aerosol ≥99%
P100 Oil aerosol ≥99.7%
- - Surgical N95 ≥95%
China GB/T 18664—2002 GB 2626-2019 KN90 Salt aerosol ≥ 90%
KN95 Salt aerosol ≥ 95%
KN100 Salt aerosol ≥ 99.97%
KP90 Oil aerosol ≥ 90%
95 Oil aerosol ≥ 95%
100 Oil aerosol ≥ 99.97%
NMPA GB 19083-2010 Level l Non-oil aerosol ≥95%
Level II Non-oil aerosol ≥99%
Level III Non-oil aerosol ≥99.97%
EU (EU) 2016/425, EN 529:2005 EN 149:2001+A1:2009 FFP3 ≥99%
FFP2 ≥94%
FFP1 ≥80%
India - IS 9473:2002 FFP3 Salt aerosol ≥97% and Oil aerosol ≥ 99%
FFP2 Salt aerosol ≥94% and Oil aerosol ≥98%
FFP1 Salt aerosol ≥80%
United States OSHA 29 CFR1910.134 NIOSH: 42 CFR 84 N95 ≥95%
N99 ≥99%
N100 ≥99.7%
R95 ≥95%
R99 ≥99%
R100 ≥99.7%
P95 ≥95%
P99 ≥99%
P100 ≥99.7%
OSHA: 29 CFR 1910.134 NIOSH: 42 CFR 84 Surgical N95 ≥95%
FDA: 21 CFR 878.4040 ASTM F2100 ≥95%

Key testing parameters

While there are many testing parameters for measuring the quality and performance attributes of respirators, below are key testing parameters to take note of:

Test ParameterTest ObjectiveMeasurement
Bacterial Filtration Efficiency (BFE) Resistance of the mask against bacterial agents Results are reported as percentage efficiency rating. The higher the number in this test indicates better barrier efficiency
Particle Filtration Efficiency (PFE) Resistance of the mask against particles larger than 1 micron Results are reported as percentage efficiency rating. The higher the number in this test indicates better filtration efficiency*
Fluid Resistance Testing Resistance of the mask against liquid splashes such as blood or other bodily fluids Results are reported as pressure with or without any fluid penetration observed at the back side of mask. The higher value without penetration indicates better resistance.
Breathability Testing - Differential Pressure Easiness of the wearer to breath comfortably in the mask Lower breathing resistance indicates a better level of comfort for the wearer
Microbial Cleanliness Total number of viable micro-organism on the mask Results are reported in units of micro-organism, lower the value more cleanliness

*higher filtration efficiency also indicates higher difficulty for air to pass through the mask. In this case, breathability testing is recommended.

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