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The NIOSH air filtration rating is the U.S.
National Institute for Occupational Safety and Health The National Institute for Occupational Safety and Health (NIOSH, ) is the List of United States federal agencies, United States federal agency responsible for conducting research and making recommendations for the prevention of work-related occ ...
(NIOSH)'s classification of filtering
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 ...
s. The ratings describe the ability of the device to protect the wearer from solid and liquid
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 ...
in the air. The certification and approval process for respiratory protective devices is governed by Part 84 of Title 42 of the
Code of Federal Regulations In the law of the United States, the ''Code of Federal Regulations'' (''CFR'') is the codification of the general and permanent regulatory law, regulations promulgated by the executive departments and agencies of the federal government of the ...
(42 CFR 84). Respiratory protective devices so classified include air-purifying respirators (APR) such as filtering facepiece respirators and chemical protective cartridges that have incorporated particulate filter elements. The NIOSH-provided classifications only cover the filtration of particles or
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, not the air-purifying respirator's ability to remove chemical gasses and vapors from air, which is regulated under 42 CFR 84 Subpart L. For
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 ...
classifications, NIOSH, under 42 CFR 84, partially defers to
American National Standard 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 ...
ANSI K13.1-1973. All classifications assume that the respirator is properly fitted.


NIOSH ratings trademark

It is illegal in the United States to use filtration terms coined under 42 CFR 84, or mark masks with the word "NIOSH" without the approval of NIOSH. Information about approved respirators can be found in the NIOSH certified equipment list (CEL).


Early NIOSH/USBM classifications


30 CFR 14 Schedule 21


30 CFR 11

Prior to the approval of 42 CFR 84, MSHA and NIOSH approved respirators under 30 CFR 11. Non-powered respirator filters were classified based on their design against a contaminant, including substances like Dusts, Fumes, Mists,
radionuclides A radionuclide (radioactive nuclide, radioisotope or radioactive isotope) is a nuclide that has excess numbers of either neutrons or protons, giving it excess nuclear energy, and making it unstable. This excess energy can be used in one of three ...
, and
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 ...
. Dust/Mist was usually tested with silica, and Fume was usually tested with
lead Lead () is a chemical element; it has Chemical symbol, symbol Pb (from Latin ) and atomic number 82. It is a Heavy metal (elements), heavy metal that is density, denser than most common materials. Lead is Mohs scale, soft and Ductility, malleabl ...
fume. The most popular respirator filters were often referred to as DM (Dust/Mist) or DFM (Dust/Fume/Mist) in
CDC The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency under the Department of Health and Human Services (HHS), and is headquartered in Atlanta, ...
and NIOSH literature as shorthand. Non-powered filters were also classified under the HEPA specification, if applicable. Only 30 CFR 11 HEPA filters were permitted by NIOSH for the prevention of
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 ...
and
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 ...
-related diseases. NIOSH was concerned about users choosing inappropriate respirators, like confusion over choosing DM or DFM respirators with regards to particle penetration, so proposed Part 84 rules in 1994 dropped the contaminant/HEPA classification for most respirators in favor of three specifications, Type A, B and C, each representing filtration of 99.97%, 99%, and 95% respectively, with Type A proposed to be used in place of HEPA for non-powered respirators. In 1973, the
Los Alamos National Laboratory Los Alamos National Laboratory (often shortened as Los Alamos and LANL) is one of the sixteen research and development Laboratory, laboratories of the United States Department of Energy National Laboratories, United States Department of Energy ...
(LANL) recommended NIOSH use
NaCl Sodium chloride , commonly known as 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 as the mineral hali ...
aerosol to test DM and DFM filters. Results from those tests showed significant leakage, with efficiency levels measured at around 75% to 90%. LANL noted that lead fume would plug the tested filters, increasing the apparent filtration efficiency of the filter.


Transition


Current classifications


42 CFR 84

Under the current revision of Part 84 established in 1995, NIOSH established nine classifications of approved particulate filtering respirators based on a combination of the respirator series and efficiency level. The first part of the filter's classification indicates the series using the letters N, R, or P to indicate the filter's resistance to filtration efficiency degradation when exposed to oil-based or oil-like aerosols (e.g., lubricants, cutting fluids, glycerine, etc.). Definitions and intended use for each series is indicated below. * N for ''not resistant to oil''. Used when oil particulates are not present. Tested using
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 ...
particles. * R for ''resistant to oil''. Used when oil particulates are present and the filter is disposed of after one shift. Tested using
dioctyl phthalate Bis(2-ethylhexyl) phthalate, di-2-ethylhexyl phthalate, diethylhexyl phthalate, diisooctyl phthalate, DEHP; incorrectly — dioctyl phthalate, DIOP) is an organic compound with the formula C6H4(CO2C8H17)2. DEHP is the most common member of the cl ...
(DOP) oil particles. * P for ''oil-proof''. Used when oil particulates are present and the filter is re-used for more than one shift. Tested with DOP oil particles. The second value indicates the minimum efficiency level of the filter. When tested according to the protocol established by NIOSH each filter classification must demonstrate the minimum efficiency level indicated below. All respirator types are permitted for TB. Class-100 filters can block
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 ...
. For ''N'' type filters, a 200 mg load of
NaCl Sodium chloride , commonly known as 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 as the mineral hali ...
is used, with an undefined service time. For ''R'' type filters, a 200 mg of DOP is used, with a defined service time of "one work shift". For ''P'' type filters, an indefinite amount of DOP is used until filtration efficiency stabilizes. P100 filters, under 42 CFR part 84, are the only filters permitted to be magenta in color. HE (high-efficiency) labeled filters (described in the subsection) are only provided for
powered air-purifying respirator A powered air-purifying respirator (PAPR) is a type of respirator used to safeguard workers against contaminated air. PAPRs consist of a headgear-and-fan assembly that takes ambient air contaminated with one or more type of pollutant or pathog ...
s. HE-marked filters are 99.97% efficient against 0.3
micron The micrometre (English in the Commonwealth of Nations, Commonwealth English as used by the International Bureau of Weights and Measures; SI symbol: μm) or micrometer (American English), also commonly known by the non-SI term micron, is a uni ...
particles and are oil-proof. Since filters are tested against the ''by definition'' most penetrating particle size of 0.3
μm The micrometre (Commonwealth English as used by the International Bureau of Weights and Measures; SI symbol: μm) or micrometer (American English), also commonly known by the non-SI term micron, is a unit of length in the International System ...
, an APR with a P100 classification would be at least 99.97% efficient at removing particles of this size. Particles with a size both less than and greater than 0.3 μm may be filtered at an efficiency greater than 99.97%. However, this may not always be the case, as the most penetrating particle size for N95s was measured to be below 0.1 μm, as opposed to the predicted size of between 0.1 and 0.3 μm.


2020 powered air-purifying respirator update


Chemical cartridge and canister classifications

Under 42 CFR 84, chemical cartridges and gas mask canisters are defined separately. Use of the TC-14G canister schedule or the TC-23C chemical cartridge schedule for a given respirator depends on whether "acid gas" is a designated contaminant, which is designated for gas mask canisters only, or if the manufacturer is obligated to list all designated contaminants supported by a given chemical cartridge. 42 CFR 84 Subsection L describes seven types of chemical cartridge respirators with maximum use concentrations and penetration, noting that colors and markings are definitively based on
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. A TB guide, published by NIOSH in 1999, describes 13 combinations of contaminants with unique color markings. The definitive guide from ANSI, who, since the passage of 42 CFR 84 in 1995, has published a 2001 revision of K13.1-1973, named Z88.7-2001, describes 14 combinations of contaminants with unique color markings, based on 13 out of the 28 NIOSH Protection Designations. The ANSI standard also notes that these classifications do not apply in aviation or military respirators. A comparison table below that details the NIOSH protection designations, 42 CFR 84, the Navy/Marine Field Manual, the NIOSH TB guide, and whether they match up with the (42 CFR 84-declared ANSI K13.1-1973 revision) ANSI Z88.7-2001 colors, for each type of chemical cartridge is described below. Note that, while the 2001 revision to ANSI K13.1-1973 provides exact colors under the
Munsell Color System The Munsell color system is a color space that specifies colors based on three properties of color: hue (basic color), value (lightness), and colorfulness, chroma (color intensity). It was created by Albert Henry Munsell, Albert H. Munsell in the ...
, colors and combinations outside the
public domain The public domain (PD) consists of all the creative work to which no Exclusive exclusive intellectual property rights apply. Those rights may have expired, been forfeited, expressly Waiver, waived, or may be inapplicable. Because no one holds ...
, as well as cartridge/canister designation, have been omitted to facilitate this fair use comparison: For particulate respirators, while NIOSH designates P100 as filter cartridges that can use the "magenta" color, ANSI designates P100 as "purple", a color which can be seen on some P100 filter cartridges. In addition, the 2001 revision to ANSI K13.1-1973 provides exclusive colors to be used for non-P100 cartridge filters, in two categories: oil-resistant (remaining R- and P- NIOSH ratings), and non-oil resistant (all N-ratings). By definition, ANSI Z88.2-2015 considers N100, R100, P100, and HE as HEPA filters.


Table of TC/BM approval schedules

NIOSH The National Institute for Occupational Safety and Health (NIOSH, ) is the United States federal agency responsible for conducting research and making recommendations for the prevention of work-related injury, illness, disability, and death. It ...
is the current regulator of all the respirators in this schedule, under 42 CFR 84. 'BM' stands for the
US Bureau of Mines The United States Bureau of Mines (USBM) was the primary Federal government of the United States, United States government agency in the 20th century that conducted scientific research and disseminated information on the extraction, processing ...
, the historical regulator of respirators in the United States. TC-21C respirator approval numbers for negative-pressure particulate respirators have three digits, in the form: TC-21C-###, while TC-84A respirator approval numbers have four digits, in the form: TC-84A-####. 42 CFR 84 (until 2020) did not change regulation regarding powered-air purifying particulate respirators, so have continued under TC-21C approval, with four digits, in the form TC-21C-####.


NIOSH Certified Equipment List


NIOSH rating limitations

NIOSH air filtration ratings do not test the fit of a respirator. Fit testing is required by
OSHA The Occupational Safety and Health Administration (OSHA; ) is a regulatory agency of the United States Department of Labor that originally had federal visitorial powers to inspect and examine workplaces. The United States Congress established ...
for employers when a hazard is present, and voluntary respirator use under Appendix D is not allowed due to the hazard. Rules for fit testing are also defined by
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 ...
Z88.2. Z88.2 notes that, in
Canada Canada is a country in North America. Its Provinces and territories of Canada, ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, making it the world's List of coun ...
, respirator care and fit testing are defined by CSA Z94.4.


Similar standards

A few other jurisdictions use standards similar to the NIOSH scheme to classify mechanical filter respirators. They include: * China (GB 2626-2019): Similar testing requirements and grades. Has "KN" and "KP" resistance levels, 90/95/99. Has additional EU-like rules on leakage. * Mexico (NOM-116-2009): Same grades. * South Korea (KMOEL - 2017-64): EU grades, KF 80/94/99 for second/first/special


See also

*
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 ...
*
Division of Industrial Hygiene The Division of Industrial Hygiene was a division of the United States Public Health Service, U.S. Public Health Service (PHS) with responsibility for occupational safety and health programs. It existed from 1914 until 1971, when it became the Na ...
*
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 ...
*
NIOSH The National Institute for Occupational Safety and Health (NIOSH, ) is the United States federal agency responsible for conducting research and making recommendations for the prevention of work-related injury, illness, disability, and death. It ...
* European respirator standards


References


Selected sources


Works cited on this page


Further reading

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External links


NIOSH Certified Equipment List (CEL)




*


OSHA math model tool for replacement of chemical cartridges
{{Breathing apparatus, industrial Air pollution National Institute for Occupational Safety and Health Occupational safety and health Respirators