dph medical supplies

Face Mask

What are the standards that must be respected for masks?

Each of these two types of masks are subject to different standards and regulations depending on the country or geographical area.

Surgical masks: these masks are tested in the direction of exhalation (from inside to outside). The tests take into account the efficiency of bacterial filtration. They must meet the following regional standards:

  • European standard EN 14683. According to this standard there are three types of effectiveness:

    • Type 1 or BFE1 with a bacterial filtration efficiency of over 95%.

    • Type 2 or BFE2 with a bacterial filtration efficiency of over 98%.

    • Type R: the European standard also adds a test of resistance to projection for types 1R and 2R, 2R being the most resistant.

  • In the United States surgical masks must comply with ASTM standards. There are three levels of protection:

    • Level 1: for a low risk of exposure to fluids.

    • Level 2: for a moderate risk of exposure to fluids.

    • Level 3: for a high risk of exposure to fluids.

Respirators: these masks are tested in the direction of inspiration (from outside to inside). The tests take into account the efficiency of the filter and leakage to the face. They must meet the following regional standards:

  • European standard EN 149: 2001. According to this standard, there are three classes of disposable particulate respirators:
    • FFP1: the least filtering of the three masks with an aerosol filtration of at least 80% and leakage to the inside of maximum 22%; it is mainly used as a dust mask (home renovations and various types of work).
    • FFP2: minimum 94% filtration percentage and maximum 8% leakage to the inside; mainly used in construction, agriculture, the pharmaceutical industry and by healthcare professionals against influenza viruses or respiratory illnesses such as avian flu, SARS, pneumonic plague, tuberculosis and most recently the new coronavirus.
    • FFP3: minimum filtration percentage of 99% and maximum 2% leakage to the inside; it is the most filtering mask of the FFPs and protects against very fine particles such as asbestos.
  • In the United States, respirators must meet NIOSH (National Institute for Occupational Safety and Health) standards. Within this standard, there are several classes of respirators depending on the degree of oil resistance:
    • Class N: no oil resistance. A distinction is made between N95, N99 and N100. The number after the letter indicates the percentage of filtration of suspended particles.
    • Class R: mask resistant to oil for up to eight hours. Here again, a distinction is made between R95, R99 and R100.
    • Class P: a completely oil-resistant mask. There are also P95, P99 and P100.
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