FFP MASKS TESTING
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Regulation

VITO performs tests on FFP masks under accreditation according to NBN EN 149+A1
and EN 13274-7. Community masks are tested according to NBN/DTD S 65-001.

The half mask test to be used depends on the intended use and production volume.

A distinction can be made between the different types of half masks:

  • Artisan masks, Do It Yourself (DIY) masks that are not made in series production and that serve as a supplement to the generally applicable protective measures such as social distancing and hand hygiene.
  • Community masks are made in series production, from materials that have proven their specific function through scientific testing. These also serve as a supplement to the generally applicable protective measures such as social distancing and hand hygiene.
  • Medical half masks (or surgical mask). These must meet all the requirements set out in the Regulation (EU) 2017/745/Directive 93/42/EEG on medical devices. These masks protect the patient from secretions from the health workers.
  • The FFP1, FFP2 and FFP3 half masks (or respiratory half masks, EN 149) are personal protective equipment (PPE). These must meet all requirements set out in Regulation (EU) 2016/425 on personal protective equipment. These masks protect the wearer from particles.
  • The respiratory protective devices (Half masks and quarter masks, EN 140) are facepieces that can be used in negative pressure isolation chambers and powered or supplied air systems. If used in a negative pressure isolation chamber, the mask should have filters conforming to EN 141, EN 143, EN 371 or EN 372 attached to it. The facepiece is generally made of flexible rubber or silicone and can be fitted with a range of replaceable filters that conform with the requirements specified in EN 141, EN 143, EN 371, and EN 372. 
  • Respiratory protective devices (Half masks, EN1827)  without inhalation valves and reusable with separable filters to protect against gases or gases and particles or particles only (designed for a maximum of single shift use). It does not cover devices designed for use in circumstances where there is or might be an oxygen deficiency (oxygen less than 17 % by volume) or for escape purposes.

For the artisan and community masks (bullets 1 and 2) the technical document NBN DTD S 65-001: 2020 - 'Community and Artisan masks - Guide of the minimum requirements, confection, maintenance and use' and the CWA 17553: 2020 'Community face coverings - Guide to minimum requirements, methods of testing and use' applies, which do not comply with Regulation (EU) 2017/745 / Directive 93/42/EEG on medical devices, nor with Regulation (EU) 2016/425 on personal protective equipment.

The standard EN 14683: 2019+AC: 2019 applies for the medical half masks and the standard NBN EN 149+A1: 2009 for PPE.

Due to the shortage on the Belgian market of FFP2 and FFP3 masks for protection against SARS-COV-2, importers are attempting to bring batches of PPE onto the market that do not have the correct certificates, in particular the full EN149 test results and an EU conformity assessment including CE marking. Because of the shortage on the one hand, but to still offer sufficient protection on the other, the federal  public service has developed an Alternative Test Protocol (ATP) that must be carried out before the temporary (during the duration of the pandemic) release of these masks that are not fully compliant. Specifically to protection against SARS-COV-2.
The packaging must be provided with a sticker (link) that depends on the test results.

For questions about regulation, you can contact:  
Gert Otten
tel. 0032 14 33 53 51
gert.otten@vito.be