It is fundamental that the sops are followed correctly for making face masks as these are life-saving products, and any negligence can cause severe damage. Similarly, the quality of the face mask is also important, and it is the part of sops to ensure the quality of face masks.
The standard operating procedure is a set of instructions applied for daily routine work in certain cases (where necessary). The purpose of SOP to carry out the work in the same manner and correctly. SOPs are compulsory and to follow at any cost; the deviation is possible if instructed or documented by some authority.
For the manufacturing of medical products, there is a standard operating procedure. But to ensure the quality of the product, there are some other standards set by every country.
For the functioning of the face mask, there are some specifications for Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE)
These specifications are provided by international standards.
In the case of PFE (for a dust respirator), standards are
● EN Specifications EN 149 (By European Union)
● NIOSH Specifications NIOSH 42CFR84 (By National Institute of Occupational Safety and Health)
● Japan National Assay Specifications JMHLW-Notification 124
● Chinese National Standards GB2626
● Aus/Nz Respiratory Protection Standard AS/NZ 1716
● Korean Standard KMOEL-2017-64
Specification for Medical Face Masks
Face masks used by medical health professionals have these specifications.
● Bacterial Filtration Efficiency
● Pressure Drop
The additional specifications
● Particle Filtrations Efficiency
● Fluid Resistant
In the case of BFE, standards are
China: YY 0469 | ≥95% | | |
USA: ASTM F2100 | Level 1 | Level 2 | Level 3 |
| ≥95% | ≥98% | ≥98% |
Europe: EN 14683 | Type 1 | Type 2 | Type 3 |
| ≥95% | ≥98% | ≥98% |
Here is the list of the face masks of different standards of various countries.
FFP (FFP1, FFP2, and FFP3)
These are the types of respirators of European standards commonly called filtering facepieces. These respirators have three levels and work according to the level.
FFP1 filters non-toxic materials. (80% filtration rate)
FFP2 filters low-level toxic materials. (94% filtration rate)
FFP3 filters high-level toxic materials. (99% filtration rate)
N95, N99, and N100
These are American standard filtering facepiece respirators approved by NIOSH. These are also made up of polymer fibers, polypropylene, and by melt blow forming layers of filtration. The efficiency of N95 is almost 95% equivalent to FFP2.
Coming in the series N99 is equivalent to the FFP3 to protect 99% air-borne particles. In comparison, N100 does have at least 99.97% filter capacity.
KN95. KN99, and KN100
KN95 is the barrier against the air-borne material. It’s a waterproof 5 layered face respirator. These masks are regulated by China. The filtration capacity of KN95 is equal to the N95. KN99 and KN100 are similar to the N99 and N100 in standards.
P1, P2, and P3
These are the respiratory guides given by Australia/New Zealand. The filtration efficiency of P1 is ≥80%. P2 has efficiency equal to 94%, and P3 has a filtration rate of ≥99%.
It is notable that the standards of different countries match with each other. Korean filtration efficiency is similar to EU standards. The Chinese and American standards are quite similar to PFE. While standards of the EU and the USA are similar in the case of BFE.