Standards Around Masks and PPEs

Now that you know the basics of the three types of PPE masks, you should familiarize yourself with the different standards around them. Standards are determined by the country of origin; the US, China and Europe.

PPE masks and their standards

In the US, standards are managed by the National Institute for Occupational Safety and Health (NIOSH). In Europe, mask standards are set by the European Committee for Standardisation (CEN). Meanwhile, the Chinese government regulates those in China. 

Surgical Mask Standards 

China: YY 0469

Filtration effectiveness: 3.0 microns ≥ 95% | 0.1 microns ≥ 30%

USA: ASTM F2100

The filtration effectiveness is divided into three levels:

  • Level 1: 3.0 microns ≥ 95% | 0.1 microns ≥ 95%
  • Level 2: 3.0 microns ≥ 98% | 0.1 microns ≥ 98%
  • Level 3: 3.0 microns ≥ 98% | 0.1 microns ≥ 98%

Europe: EN 14683

Again, filtration effectiveness is divided into three levels:

  • Type 1: 3.0 microns ≥ 95%
  • Type 2: 3.0 microns ≥ 98%
  • Type 3: 3.0 microns ≥ 98%

There is no requirement for 0.1 microns.

Respirator Mask Standards

China: GB2626

USA: NIOSH (42 CFR 84)

Both the Chinese and American standards meet three tiers:

  • KN95/N95: 0.3 microns ≥ 95%
  • KN99/N99:  0.3 microns ≥ 99%
  • KN100/N100: 0.3 microns ≥ 97.97%

Europe: EN 149:2001

  • FFP1: 0.3 microns ≥ 80%
  • FFP2: 0.3 microns ≥ 94% 
  • FFP3: 0.3 microns ≥ 99%

3.0 microns = Bacteria Efficiency Standard (BFE)

0.1 microns = Particle Filtration Efficiency Standard (PFE)

0.3 microns = Represents the most penetrating particle size (MPPS)

To put this into perspective, the size of a coronavirus particle is around 0.1 microns.

What does the mask standards mean

The filtration percentages shown above for the types of mask indicate that the mask must filter at least that percentage. So, an N95 mask will filter at least 95% of particles. Standards are assigned per mask type and by country. As you can see, whilst the filtration standards do vary it is only a marginal variation. 

Surgical facemasks meet higher requirements than the single-use facemasks which are available to the wider public. A surgical mask is not considered to offer respiratory protection to the wearer but it will shield patients from respiratory droplets.

Respirator masks such as the N95 and FFP2 offer a more reliable source of protection to both the wearer and those in contact with the wearer. They protect against small particle aerosols and droplets, but they do not protect against non-oil aerosols. The ‘N’ stands for ‘non-oil’ as a reminder.

Testing and Approval of PPE Masks

All surgical masks are cleared by the FDA but they are not tested. A respirator, on the other hand, is subject to testing and evaluation as per the organisations listed above. The testing process assesses the level of filtration and degree of leakage. 

DIY facemasks and cloth coverings that civilians can make from home are not subject to testing. Whilst they do offer a level of protection, they should not be worn by medical practitioners. 

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