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The European respirator standards refer to the filtering classification by EN 149, EN 14683, and EN 143, all
European standard European Standards, sometimes called Euronorm (abbreviated EN, from the German name , "European Norm"), are technical standards which have been ratified by one of the three European Standards Organizations (ESO): European Committee for Standardizat ...
s of testing and marking requirements for respirators. FFP standard masks (where FFP stands for filtering facepiece) 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 respirator Mechanical filters, a part of particulate respirators, are a class of Air filter, filter for air-purifying respirators that mechanically stops particulates from reaching the wearer's nose and mouth. They come in multiple physical forms. Mechani ...
s protect against the inhalation of
particulates Particulate matter (PM) or particulates are microscopic particles of solid or liquid matter suspension (chemistry), suspended in the atmosphere of Earth, air. An ''aerosol'' is a mixture of particulates and air, as opposed to the particulate ...
such as
dust Dust is made of particle size, fine particles of solid matter. On Earth, it generally consists of particles in the atmosphere that come from various sources such as soil lifted by wind (an aeolian processes, aeolian process), Types of volcan ...
particle In the physical sciences, a particle (or corpuscle in older texts) is a small localized object which can be described by several physical or chemical properties, such as volume, density, or mass. They vary greatly in size or quantity, from s ...
s, droplets, and
aerosol An aerosol is a suspension (chemistry), suspension of fine solid particles or liquid Drop (liquid), droplets in air or another gas. Aerosols can be generated from natural or Human impact on the environment, human causes. The term ''aerosol'' co ...
s. EN 14683 defines respirators for use in medical settings, while
European standard European Standards, sometimes called Euronorm (abbreviated EN, from the German name , "European Norm"), are technical standards which have been ratified by one of the three European Standards Organizations (ESO): European Committee for Standardizat ...
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 respirator Elastomeric respirators, also called reusable air-purifying respirators, seal to the face with elastomeric material, which may be a Natural rubber, natural or synthetic rubber. They are generally reusable. Full-face versions of elastomeric respi ...
s. EN 14387 is the
chemical cartridge A respirator cartridge or gas mask canister is a type of filter that removes gases, volatile organic compounds (VOCs), and other vapors from the air through adsorption, absorption, or chemisorption. It is one of two basic types of filters used ...
standard in Europe. 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 mask An N95 respirator is a disposable filtering facepiece respirator or reusable elastomeric respirator filter that meets the U.S. National Institute for Occupational Safety and Health (NIOSH) N95 standard of air filtration, filtering at least 95% ...
s in the United States and
KN95 Mechanical filters, a part of particulate respirators, are a class of filter for air-purifying respirators that mechanically stops particulates from reaching the wearer's nose and mouth. They come in multiple physical forms. Mechanism of opera ...
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 Pressure drop (often abbreviated as "dP" or "ΔP") is defined as the difference in total pressure between two points of a fluid carrying network. A pressure drop occurs when frictional forces, caused by the resistance to flow, act on a fluid as i ...
levels.


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.


EN 14683 and EN 143

European standard European Standards, sometimes called Euronorm (abbreviated EN, from the German name , "European Norm"), are technical standards which have been ratified by one of the three European Standards Organizations (ESO): European Committee for Standardizat ...
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 respirator Elastomeric respirators, also called reusable air-purifying respirators, seal to the face with elastomeric material, which may be a Natural rubber, natural or synthetic rubber. They are generally reusable. Full-face versions of elastomeric respi ...
s. Both European standard EN 143 and EN 149 test filter penetration with dry
sodium chloride Sodium chloride , commonly known as Salt#Edible salt, edible salt, is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. It is transparent or translucent, brittle, hygroscopic, and occurs a ...
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 A truncated mean or trimmed mean is a statistical measure of central tendency, much like the mean and median. It involves the calculation of the mean after discarding given parts of a probability distribution or sample at the high and low end, a ...
of average leakage from 8 individuals must not exceed the aforementioned values.alternative source
/ref>


FFP1 mask

It is the least filtering mask of the three. *
Aerosol An aerosol is a suspension (chemistry), suspension of fine solid particles or liquid Drop (liquid), droplets in air or another gas. Aerosols can be generated from natural or Human impact on the environment, human causes. The term ''aerosol'' co ...
filtration Filtration is a physical separation process that separates solid matter and fluid from a mixture using a ''filter medium'' that has a complex structure through which only the fluid can pass. Solid particles that cannot pass through the filte ...
percentage: 80% minimum * Internal leak rate: maximum 22% It is mainly used as a
dust mask A dust mask is a flexible paper pad held over the nose and mouth made for protection against ''chronically'' toxic nuisance dusts, like from occupational exposure to plant dusts like hay. They are not intended to provide protection from most ai ...
(for example for DIY jobs).
Dust Dust is made of particle size, fine particles of solid matter. On Earth, it generally consists of particles in the atmosphere that come from various sources such as soil lifted by wind (an aeolian processes, aeolian process), Types of volcan ...
can cause
lung disease The lungs are the primary organs of the respiratory system in many animals, including humans. In mammals and most other tetrapods, two lungs are located near the backbone on either side of the heart. Their function in the respiratory syst ...
s, such as
silicosis Silicosis is a form of occupational lung disease caused by inhalation of crystalline silica dust. It is marked by inflammation and scarring in the form of Nodule (medicine), nodular lesions in the upper lobes of the lungs. It is a type of pneum ...
,
anthracosis Black lung disease (BLD), also known as coal workers' pneumoconiosis, or simply black lung, is an occupational type of pneumoconiosis caused by long-term inhalation and deposition of coal dust in the lungs and the consequent lung tissue's reacti ...
,
siderosis Siderosis is the deposition of excess iron in body tissue. When used without qualification, it usually refers to an environmental disease of the lung, also known more specifically as pulmonary siderosis or Welder's disease, which is a form of pn ...
and
asbestosis Asbestosis is long-term inflammation and pulmonary fibrosis, scarring of the human lung, lungs due to asbestos fibers. Symptoms may include shortness of breath, cough, wheezing, and chest pain, chest tightness. Complications may include lung canc ...
(in particular dust from
silica Silicon dioxide, also known as silica, is an oxide of silicon with the chemical formula , commonly found in nature as quartz. In many parts of the world, silica is the major constituent of sand. Silica is one of the most complex and abundant f ...
,
coal Coal is a combustible black or brownish-black sedimentary rock, formed as rock strata called coal seams. Coal is mostly carbon with variable amounts of other Chemical element, elements, chiefly hydrogen, sulfur, oxygen, and nitrogen. Coal i ...
,
iron ore Iron ores are rocks and minerals from which metallic iron can be economically extracted. The ores are usually rich in iron oxides and vary in color from dark grey, bright yellow, or deep purple to rusty red. The iron is usually found in the f ...
,
zinc Zinc is a chemical element; it has symbol Zn and atomic number 30. It is a slightly brittle metal at room temperature and has a shiny-greyish appearance when oxidation is removed. It is the first element in group 12 (IIB) of the periodic tabl ...
,
aluminium Aluminium (or aluminum in North American English) is a chemical element; it has chemical symbol, symbol Al and atomic number 13. It has a density lower than that of other common metals, about one-third that of steel. Aluminium has ...
or
cement A cement is a binder, a chemical substance used for construction that sets, hardens, and adheres to other materials to bind them together. Cement is seldom used on its own, but rather to bind sand and gravel ( aggregate) together. Cement mi ...
are common particulate risks).


FFP2 mask

* Aerosol filtration percentage: 94% minimum * Internal leak rate: maximum 8% This mask offers protection in various areas such as the
glass Glass is an amorphous (non-crystalline solid, non-crystalline) solid. Because it is often transparency and translucency, transparent and chemically inert, glass has found widespread practical, technological, and decorative use in window pane ...
industry,
foundry A foundry is a factory that produces metal castings. Metals are cast into shapes by melting them into a liquid, pouring the metal into a mold, and removing the mold material after the metal has solidified as it cools. The most common metals pr ...
,
construction Construction are processes involved in delivering buildings, infrastructure, industrial facilities, and associated activities through to the end of their life. It typically starts with planning, financing, and design that continues until the a ...
,
pharmaceutical Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...
industry and
agriculture Agriculture encompasses crop and livestock production, aquaculture, and forestry for food and non-food products. Agriculture was a key factor in the rise of sedentary human civilization, whereby farming of domesticated species created ...
. It effectively stops powdered chemicals. This mask can also serve as protection against respiratory viruses such as
avian influenza Avian influenza, also known as avian flu or bird flu, is a disease caused by the influenza A virus, which primarily affects birds but can sometimes affect mammals including humans. Wild aquatic birds are the primary host of the influenza A viru ...
or severe acute respiratory syndrome associated with the coronavirus (SARS), as well as against the
bacteria Bacteria (; : bacterium) are ubiquitous, mostly free-living organisms often consisting of one Cell (biology), biological cell. They constitute a large domain (biology), domain of Prokaryote, prokaryotic microorganisms. Typically a few micr ...
of
pneumonic plague Pneumonic plague is a severe lung infection caused by the bacterium '' Yersinia pestis''. Symptoms include fever, headache, shortness of breath, chest pain, and coughing. They typically start about three to seven days after exposure. It is o ...
and
tuberculosis Tuberculosis (TB), also known colloquially as the "white death", or historically as consumption, is a contagious disease usually caused by ''Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can al ...
. It is similar to the US-standard
N95 respirator An N95 respirator is a disposable Respirator#Filtering facepiece, filtering facepiece respirator or reusable elastomeric respirator filter that meets the U.S. National Institute for Occupational Safety and Health (NIOSH) N95 standard of air fi ...
.


FFP3 mask

*
Aerosol An aerosol is a suspension (chemistry), suspension of fine solid particles or liquid Drop (liquid), droplets in air or another gas. Aerosols can be generated from natural or Human impact on the environment, human causes. The term ''aerosol'' co ...
filtration percentage: 99% minimum * Internal leak rate: maximum 2% The FFP3 mask is the most filtering of the FFP masks. It protects against very fine particles such as
asbestos Asbestos ( ) is a group of naturally occurring, Toxicity, toxic, carcinogenic and fibrous silicate minerals. There are six types, all of which are composed of long and thin fibrous Crystal habit, crystals, each fibre (particulate with length su ...
and
ceramic A ceramic is any of the various hard, brittle, heat-resistant, and corrosion-resistant materials made by shaping and then firing an inorganic, nonmetallic material, such as clay, at a high temperature. Common examples are earthenware, porcela ...
. It does not protect against gases and in particular oxides of nitrogen.


Requirements

EN 149 defines laboratory tests, field tests and certain requirements to ensure the
conformity Conformity or conformism is the act of matching attitudes, beliefs, and behaviors to social group, group norms, politics or being like-minded. Social norm, Norms are implicit, specific rules, guidance shared by a group of individuals, that guide t ...
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 France, officially the French Republic, is a country located primarily in Western Europe. Overseas France, Its overseas regions and territories include French Guiana in South America, Saint Pierre and Miquelon in the Atlantic Ocean#North Atlan ...
*INSPEC in
Great Britain Great Britain is an island in the North Atlantic Ocean off the north-west coast of continental Europe, consisting of the countries England, Scotland, and Wales. With an area of , it is the largest of the British Isles, the List of European ...
*
Institute for Occupational Safety and Health of the German Social Accident Insurance The Institute for Occupational Safety and Health of the German Social Accident Insurance (, IFA) is a German institute located in Sankt Augustin near Bonn and is a main department of the German Social Accident Insurance. Belonging to the Statuto ...
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 Personal protective equipment (PPE) is protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection. The hazards addressed by protective equipment include physical, elect ...
(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 Infection prevention and control (IPC) is the discipline concerned with preventing healthcare-associated infections; a practical rather than academic sub-discipline of epidemiology. In Northern Europe, infection prevention and control is expande ...
against
airborne transmission Airborne transmission or aerosol transmission is transmission of an infectious disease through small particles suspended in the air. Infectious diseases capable of airborne transmission include many of considerable importance both in human a ...
of
pathogens In biology, a pathogen (, "suffering", "passion" and , "producer of"), in the oldest and broadest sense, is any organism or agent that can produce disease. A pathogen may also be referred to as an infectious agent, or simply a germ. The term ...
through
respiratory droplet A respiratory droplet is a small aqueous droplet produced by exhalation, consisting of saliva or mucus and other matter derived from respiratory tract surfaces. Respiratory droplets are produced naturally as a result of breathing, speaking, s ...
s. 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 A respirator cartridge or gas mask canister is a type of filter that removes gases, volatile organic compounds (VOCs), and other vapors from the air through adsorption, absorption, or chemisorption. It is one of two basic types of filters used ...
standard. It is similar in scope to
ANSI The American National Standards Institute (ANSI ) is a private nonprofit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organiz ...
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: * Russia (GOST R 12.4.191-2011): identical. * South Korea (KMOEL - 2017–64): considered identical to pre-2009 version. FFP1 is called "2nd grade" or KF80, FFP2 "1st grade" or KF94, and FFP3 "special grade" or KF99. * 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

*
Gas mask A gas mask is a piece of personal protective equipment used to protect the wearer from inhaling airborne pollutants and toxic gases. The mask forms a sealed cover over the nose and mouth, but may also cover the eyes and other vulnerable soft ...
*
NIOSH air filtration rating The NIOSH air filtration rating is the U.S. National Institute for Occupational Safety and Health (NIOSH)'s classification of filtering respirators. The ratings describe the ability of the device to protect the wearer from solid and liquid part ...
*
Respirator A respirator is a device designed to protect the wearer from inhaling hazardous atmospheres including lead, lead fumes, vapors, gases and particulate matter such as dusts and airborne pathogens such as viruses. There are two main categories o ...
*
Surgical mask A surgical mask, also known by other names such as a medical face mask or procedure mask, is a personal protective equipment used by healthcare professionals that serves as a mechanical barrier that interferes with direct airflow in and out of r ...
*
Face masks during the COVID-19 pandemic During the COVID-19 pandemic, face masks or coverings, including N95 respirator, N95, FFP standards#FFP2 mask, FFP2, surgical mask, surgical, and Cloth face mask, cloth masks, have been employed as public and personal health control measures ag ...


Notes and references

{{Breathing apparatus, industrial, state=expanded European Union Mechanical standards Respirators Medical masks