European respirator standards

EN 149 The EN 149 standard defines performance requirements for three classes of particle-filtering half masks: FFP1, FFP2 and FFP3. The protection provided by an FFP2 (or FFP3) mask includes the protection provided by a mask of the lower-numbered classes. A mask conforming to the standard must have its class written on it, along with the name of the standard and its year of publication, as well as any applicable option codes, e.g. “EN 149:2001 FFP1 NR D”. Some manufacturers use in addition the colour of the elastic band to identify the mask class, however, the EN 149 standard does not specify any such colour coding and different manufacturers have used different colour schemes. EN 14683 and EN 143 European standard EN 143 defines the 'P' classes of particle filters that can be attached to a face mask. These filters are typically used on reusable respirators, like elastomeric respirators. Both European standard EN 143 and EN 149 test filter penetration with dry sodium chloride and paraffin oil aerosols after storing the filters at and for 24 h each. The standards include testing mechanical strength, breathing resistance and clogging. EN 149 tests the inward leakage between the mask and face, where 10 human subjects perform 5 exercises each. The truncated mean of average leakage from 8 individuals must not exceed the aforementioned values. FFP1 mask It is the least filtering mask of the three. • Aerosol filtration percentage: 80% minimum • Internal leak rate: maximum 22% It is similar to the US-standard N95 respirator. ==Requirements==

EN 149 defines laboratory tests, field tests and certain requirements to ensure the conformity of the masks. The following points are analyzed: • Packaging • Materials: resistance to manipulation • Practical performance test • Leakage: total leakage inwards and penetration of the filter material There are some European organizations that issue an examination certificate confirming conformity and specifying the characteristics of the products: • INRS then APAVE in France • INSPEC in Great Britain • Institute for Occupational Safety and Health of the German Social Accident Insurance in Germany • CIOP-PIB in Poland 2009 version With the publication of the 2009 version of the standard, the designation of the respiratory protection mask is now "particulate filtering half mask". The abbreviation NR or R is added after FFP1, FFP2, FFP3: • NR (not reusable): if the use of the filtering half-face mask is limited to one working day. It is not reusable. • R (reusable): if the filtering half-face mask can be used for more than one working day, so it is reusable. Additional suffixes include: • Anti-clogging NR masks (D). When the half mask has passed the dolomite dust test, a letter D can be added to indicate that the service life may exceed 8 h. Example: FFP3 NR D. • Valve. The presence of a valve can be indicated by the letter V. • Particulate type. The letters S or L respectively specify the filtration of solid dust (NaCl-only) or liquid mist (paraffin oil). Example: FFP3 SLV. Masks manufactured before the new standard was taken into account may still have the old marking. Marking FFP respirators are a type of personal protective equipment (PPE). Here is the notice that should appear on every mask : • Manufacturer's name • Mask • CE number of the certification body (only FFP3) + EN 149: 2009 + the mask class (FFP1, FFP2 or FFP3) + acronym (NR or R) (Note: in case of FFP1 the conformity assessment procedures are done by the manufacturer itself as per Annex IV (Module A) The marking must comply with European Union Directive 89/686 / EEC on PPE. If any of these entries are missing, the mask will be considered non-compliant. ==Medical use==

EN 149 tests the ability of masks to protect the wearers against inhaling liquid and dry aerosols. It makes no statement about, and does not specifically test the suitability of such masks for, infection control against airborne transmission of pathogens through respiratory droplets. Nevertheless, FFP2 and FFP3 masks are commonly used for this purpose in medical practice. A researcher at the MRC Biostatistics Unit at Cambridge University claimed in 2021 that switching to FFP3 in Addenbrooke hospital in Cambridge may have cut ward-based Covid infection of staff to zero. == EN 14387 chemical cartridge classifications ==

EN 14387 is the European chemical cartridge standard. It is similar in scope to ANSI K13.1-1973. == Similar standards ==

Several regions use standards based on nearly identical tests and thresholds as those in EN 149, but with different markings: • Australia and New Zealand (AS/NZ 1716:2012): similar grades with a different test agent, with the exception of FFP3 which has no equivalent. Grades are written simply "P". • Brazil (ABNT/NBR 13698:2011): identical to pre-2009 version. Grades are written as "PFF". Other regions use similar tests that (in parts) resemble more closely the 42 CFR 84 requirements in the United States: • Japan (JMHLW-Notification 214, 2018): similar grades with a different coding scheme for NR/R and S/L types. Written with a two-letter prefix D/R and S/L that maps to NR/R and S/L respectively. Leakage requirement not present. • Taiwan (CNS 14755): D1/D2/D3 grades for 80/95/99 efficiency. No requirements for inward leakage. ==See also==