European respirator standards explained

The European respirator standards refer to the filtering half mask classification by EN 149, EN 14683, and EN 143, all European standards of testing and marking requirements for respirators. FFP standard masks (where FFP stands for filtering facepiece)[1] cover the nose, mouth and chin and may have inhalation and/or exhalation valves.

EN 149 defines three classes of such particle half masks, called FFP1, FFP2 and FFP3, according to their filtering efficiency. It also classifies masks into "single shift use only" (not re-usable, marked NR) or "re-usable (more than one shift)" (marked R), while an additional marking letter D indicates that a mask has passed an optional clogging test using dolomite dust. Such mechanical filter respirators protect against the inhalation of particulates such as dust particles, droplets, and aerosols.[2] EN 14683 defines respirators for use in medical settings,[3] while European standard EN 143 defines the 'P' classes of particle filters that can be attached to a face mask, which are P1, P2, and P3. The EN 143 filters are typically used on reusable respirators, like elastomeric respirators.[4]

Almost identical tests (but different markings) are used in Australia, New Zealand, Korea and Brazil. Similar standards are used in the United States, China and Japan. For example, EN 149 FFP2 masks have similar performance requirements to N95 masks in the United States and KN95 filters of China, and EN 149 FFP3 masks have similar performance requirements to N99 masks in the United States. However EN 149 test requirements differ somewhat from the U.S./Chinese/Japanese standards: EN 149 requires an additional paraffin oil (paraffinum perliquidum) aerosol test and it tests at a range of different flow rates and defines several associated and permissible pressure drop levels.[5] [6]

Classification

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.

Class[7] Filter penetration limit (at 95 L/min air flow)Inward leakageTypical elastic band
FFP1Filters at least 80% of airborne particles<22%Yellow
FFP2Filters at least 94% of airborne particles<8%Blue or White
FFP3Filters at least 99% of airborne particles<2%Red

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.[8]

StandardClassFilter typeFilter penetration limit (at 95 L/min air flow)Inward leakageTypical elastic band
EN 14683Type IMaskLess than 98% droplet filtration, intended for use by patientsN/AN/A
Type IINot fluid-resistant, 98% droplet filtration, intended for use by healthcare workers in droplet-free environments
Type IIRFluid-resistant, 98% droplet filtration, surgical
EN 143P1AttachmentFilters at least 80% of airborne particlesN/AN/A
P2Filters at least 94% of airborne particles
P3Filters at least 99.95% of airborne particles
Both European standard EN 143 and EN 149 test filter penetration with dry sodium chloride and paraffin oil aerosols after storing the filters at 70C and -30C 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.[9]

FFP1 mask

It is the least filtering mask of the three.

It is mainly used as a dust mask (for example for DIY jobs). Dust can cause lung diseases, such as silicosis, anthracosis, siderosis and asbestosis (in particular dust from silica, coal, iron ore, zinc, aluminium or cement are common particulate risks).

FFP2 mask

This mask offers protection in various areas such as the glass industry, foundry, construction, pharmaceutical industry and agriculture. It effectively stops powdered chemicals. This mask can also serve as protection against respiratory viruses such as avian influenza or severe acute respiratory syndrome associated with the coronavirus (SARS), as well as against the bacteria of pneumonic plague and tuberculosis.[10] It is similar to the US-standard N95 respirator.

FFP3 mask

The FFP3 mask is the most filtering of the FFP masks. It protects against very fine particles such as asbestos and ceramic. It does not protect against gases and in particular oxides of nitrogen.[11]

Requirements

EN 149 defines laboratory tests, field tests and certain requirements to ensure the conformity of the masks. The following points are analyzed:

There are some European organizations that issue an examination certificate confirming conformity and specifying the characteristics of the products:

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:

  1. NR (not reusable): if the use of the filtering half-face mask is limited to one working day. It is not reusable.
  2. R (reusable): if the filtering half-face mask can be used for more than one working day, so it is reusable.

Additional suffixes include:

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 :

The marking must comply with European Union Directive 89/686 / EEC[7] 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.[17]

Similar standards

See main article: Mechanical filter respirator. Several regions use standards based on nearly identical tests and thresholds as those in EN 149, but with different markings:

Other regions use similar tests that (in parts) resemble more closely the 42 CFR 84 requirements in the United States:

See also

Notes and References

  1. https://www.hsa.ie/eng/Publications_and_Forms/Publications/Chemical_and_Hazardous_Substances/Respiratory%20Protective%20Equipment.pdf Respiratory Protective Equipment
  2. Web site: WIP-Richtlijn Persoonlijke beschermingsmiddelen [ZKH]]. Werkgroep Infectie Preventie, RIVM. rivm.nl. September 2015. 2020-04-30.
  3. Web site: COVID-19 Technical Specifications for Personal Protective Equipment and Related IPC supplies . World Health Organization.
  4. Web site: Fiche pratique de sécurité ED 105. Appareils de protection respiratoire et métiers de la santé . 7 April 2020 . inrs.fr. INRS.
  5. Web site: Comparison of FFP2, KN95, and N95 and Other Filtering Facepiece Respirator Classes. 2020-01-01. 3M Technical Data Bulletin. 2020-03-28.
  6. Web site: Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies. 2020-03-17. U.S. Centers for Disease Control and Prevention. en-us. 2020-03-28.
  7. Web site: Fiche pratique de sécurité ED 105. Appareils de protection respiratoire et métiers de la santé . 7 April 2020 . inrs.fr. INRS.
  8. Web site: Fiche pratique de sécurité ED 105. Appareils de protection respiratoire et métiers de la santé . 7 April 2020 . inrs.fr. INRS.
  9. Web site: NF EN 149+A1. September 2009. www.boutique.afnor.org. alternative source
  10. Web site: Risques infectieux en milieu de soins - masques médicaux ou appareils de protection respiratoire jetables : quel matériel choisir ? . 16 June 2015 . 27 August 2009 . sante.gouv.fr . 13 April 2015 . https://web.archive.org/web/20150413020240/http://sante.gouv.fr/risques-infectieux-en-milieu-de-soins-masques-medicaux-ou-appareils-de-protection-respiratoire-jetables-quel-materiel-choisir.html . dead .
  11. Web site: Vélib' et pollution, les réponses du docteur Jean-Luc Saladin. 1 June 2015. https://web.archive.org/web/20140917051236/http://blog.velib.paris.fr/blog/2014/03/15/velib-et-pollution-les-reponses-du-docteur-jean-luc-saladin/. 17 September 2014 .
  12. Web site: European Commission . Notification . 2021-02-19.
  13. Web site: Department of Personal Protective Equipment. CIOP-PIB.
  14. Web site: La série 3000 FFP. MOLDEX-METRIC.
  15. Web site: 2016 Catalogue. VENUS Safety & Health Pvt. Ltd.. 2020-04-08. 2020-02-27. https://web.archive.org/web/20200227210442/http://www.mannengineers.com/assets/pdf/venus_brochure_1_60.pdf. dead.
  16. Web site: BLS Zer0 30 FFP3 Carbon Valved Face Mask. 2021-02-19. AES Industrial Supplies Limited. en-GB.
  17. News: Nicola Davis . Denis Campbell . Cambridge hospital's mask upgrade appears to eliminate Covid risk to staff Hospital: infection study shows use of FFP3 respirators at Addenbrooke's 'may have cut ward-based infection to zero' . June 29, 2021 . The Guardian . June 29, 2021 . “Once FFP3 respirators were introduced, the number of cases attributed to exposure on Covid-19 wards dropped dramatically – in fact, our model suggests that FFP3 respirators may have cut ward-based infection to zero.”.
  18. Jung . Hyejung . Kim . Jongbo . Lee . Seungju . Lee . Jinho . Kim . Jooyoun . Tsai . Perngjy . Yoon . Chungsik . Comparison of Filtration Efficiency and Pressure Drop in Anti-Yellow Sand Masks, Quarantine Masks, Medical Masks, General Masks, and Handkerchiefs . Aerosol and Air Quality Research . 2014 . 14 . 3 . 991–1002 . 10.4209/aaqr.2013.06.0201 . free.
  19. Web site: ABNT/NBR 13698:2011 E quip amento de proteção respiratória — Peça semifacial fi ltrante para partículas. pt-BR.
  20. Web site: Standard for Dust Mask . JICOSH Home . 2020-04-30 . 2020-05-25 . https://web.archive.org/web/20200525114043/https://www.jniosh.johas.go.jp/icpro/jicosh-old/english/law/DustMask/index.html . dead .