Legal requirements for medical respiratory masks

A good respirator for medical use is certified according to DIN EN 149:2001-10 or DIN EN 14683:2019 and its production series has to pass extensive tests.

In short, respirators must meet the following requirements:

  • The breathing mask must close off the face
  • The FFP2 respirator must have a maximum permeability of 8%.
  • The FFP3 respirator must have a maximum permeability of 2%.
  • The type of respirator and the number of the European standard should be clearly printed on the packaging
  • The breathing mask must withstand a pressure difference of < 40 Pa/cm² (Pascal per square centimeter)
  • The respirator must be microbiologically pure and have a maximum germ load of <= 30 CFU/g (colony-forming units per gram tested)
  • The results of the test of the respirators must be available on request
[an error occurred while processing this directive]