Earth:NIOSH air filtration rating

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Short description: U.S. rating of respirators

Template:Infobox regulated PPE Template:US respirator topics 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 particulates 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 (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 aerosols, 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 classifications, NIOSH, under 42 CFR 84, partially defers to American National Standard ANSI K13.1-1973. All classifications assume that the respirator is properly fitted.

NIOSH ratings trademark

This section is an excerpt from N95 respirator § COVID-19 pandemic[ edit ]

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).[1]

Early NIOSH/USBM classifications

30 CFR 14 Schedule 21

This section is an excerpt from N95 respirator § Early US respirator standards[ edit ]

30 CFR 11

Example Part 11 HEPA Label, TC-21C particulate, with approval for Dusts, Fumes, Mists, radionuclides, and asbestos
3M 6200 with magenta 'Dust-Fume-Mist Radionuclides Asbestos' (30 CFR HEPA) markings on the filters

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, and asbestos. Dust/Mist was usually tested with silica, and Fume was usually tested with lead fume. The most popular respirator filters were often referred to as DM (Dust/Mist) or DFM (Dust/Fume/Mist) in CDC and NIOSH literature as shorthand.[2] Non-powered filters were also classified under the HEPA specification, if applicable.[3]

Only 30 CFR 11 HEPA filters were permitted by NIOSH for the prevention of tuberculosis[C3] and asbestos-related diseases.[CF1]

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.[C1][3]

In 1973, the Los Alamos National Laboratory (LANL) recommended NIOSH use NaCl aerosol to test DM and DFM filters. Results from those tests showed significant leakage, with efficiency levels measured at around 75% to 90%.[4] LANL noted that lead fume would plug the tested filters, increasing the apparent filtration efficiency of the filter.[5]

(OBSOLETE) 30 CFR 11 efficiency levels[3][6]
Particulate Respirator
approval 		Maximum
dust penetration 		Minimum
efficiency level 		Permitted for
TB 		Permitted for
asbestos
158.4 mg silica
[convert: invalid number] air 		Single-use Dust/Mist filters 1.8 mg 98.86% No No
158.4 mg, usually silica
[convert: invalid number] air 		Replaceable Dust/Mist filters 1.5 mg 99.05% No No
0.3 micron DOP
0.05 mg per cubic meter air for particles 		HEPA (includes
Dust/Mist approval)[ND3] 		N/A 99.97% Yes Yes

Transition

This section is an excerpt from N95 respirator § 42 CFR 84[ edit ]
This section is an excerpt from N95 respirator § Approval of Part 84 and replacement of 30 CFR 11[ edit ]

Current classifications

42 CFR 84

Template:About-distinguish-text

Example Part 84 Label, TC-84A particulate, with older NIOSH logo, for P100 respirator, equivalent to Part 11 HEPA.
People wearing 3M 2091 magenta P100 filters. Note that these filters do not block vapors.

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.).[CF2][7][N2] Definitions and intended use for each series is indicated below.[8]

  • N for not resistant to oil. Used when oil particulates are not present. Tested using sodium chloride 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 (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.

NIOSH particulate respirator class minimum efficiency levels[CF2]
Particulate Respirator class Minimum efficiency
level 		Permitted for
TB 		Permitted for
asbestos
NaCl (N) or DOP (R,P) N95, R95, P95 95% Yes No
N99, R99, P99 99%
N100, R100, P100 99.97% Yes

All respirator types are permitted for TB.[9][C1] Class-100 filters can block asbestos.[10][CF1][S2] For N type filters, a 200 mg load of NaCl 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.[N2] P100 filters, under 42 CFR part 84, are the only filters permitted to be magenta in color.[11]

HE (high-efficiency) labeled filters (described in the subsection) are only provided for powered air-purifying respirators. HE-marked filters are 99.97% efficient against 0.3 micron particles and are oil-proof.[12][13][14]

Since filters are tested against the by definition most penetrating particle size of 0.3 μm, an APR with a P100 classification would be at least 99.97% efficient at removing particles of this size.[N2] Particles with a size both less than and greater than 0.3 μm may be filtered at an efficiency greater than 99.97%.[N2] 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.[15]

2020 powered air-purifying respirator update

PAPR
A person wearing a powered air-purifying respirator
This section is an excerpt from Powered air-purifying respirator § 42 CFR 84[ edit ]

Chemical cartridge and canister classifications

See also: Engineering:Chemical cartridge and Gas mask
Half-face air-purifying respirator with combination P100 particulate filter (magenta) and organic vapor (black) cartridge

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.[ND2]

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 K13.1-1973.[CF2] A TB guide, published by NIOSH in 1999, describes 13 combinations of contaminants with unique color markings.[9] 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.[S1][ND1] The ANSI standard also notes that these classifications do not apply in aviation or military respirators.[S1]

A comparison table below that details the NIOSH protection designations,[ND1] 42 CFR 84,[CF2] the Navy/Marine Field Manual,[16] the NIOSH TB guide,[9] and whether they match up with the (42 CFR 84-declared ANSI K13.1-1973 revision) ANSI Z88.7-2001 colors,[S1] 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,[S1] colors and combinations outside the public domain, as well as cartridge/canister designation, have been omitted to facilitate this fair use comparison:

Respirator/Filter type designation and color comparison[lower-alpha 1]
NIOSH protection

designations[ND1]

NIOSH protection

abbreviation[ND1]

42 CFR 84 max use concentration[CF2][lower-alpha 1] Penetration allowed by 42 CFR 84[lower-alpha 1] Efficiency level[lower-alpha 1] 1999 NIOSH TB Guide

color[9]

Correlated with Z88.7-2001

(K13.1-1973 revision)?[S1]

Acid gas (gas mask only)[ND1] AG
N/A
 White Yes, for canisters only
Ammonia AM 300 ppm 50 ppm 83.3% Green Yes
Chlorine dioxide CD
N/A
 In standard as combination
Chlorine CL 10 ppm 5 ppm 50% White with

1/2" yellow stripe

No stripe, but within designation color
Chloroacetophenone CN
N/A
Carbon monoxide CO
N/A
 Blue Yes
Chlorobenzylidene malononitrile CS
N/A
Ethylene oxide EO
Formaldehyde FM
Hydrogen chloride HC 50 ppm 5 ppm 90%
N/A
 In standard as combination
Hydrogen fluoride HF
N/A
 In standard as combination
Hydrogen cyanide HN
N/A
 White, with 1/2" green stripe No stripe, wrong color, actual color for unlisted combinations
Hydrogen sulfide HS
N/A
 In standard as combination

(escape only)

Methylamine MA 100 ppm 10 ppm 90%
N/A
 In standard with ammonia
Mercury vapor MV
N/A
Nitrogen dioxide ND
Organic Vapor OV 1000 ppm

or lower

5 ppm Depends Black Yes
Phosphine PH
N/A
Sulfur dioxide SD 50 ppm 5 ppm 90%
N/A
 In standard as combination
Vinyl chloride VC 10 ppm 1 ppm 90%
N/A
 NIOSH designation does not exist, may use unlisted combination color
Toluene diisocyanate TDI
N/A
Demand (SCBA) DE
Non-air-purifying respirators (Atmosphere-supplying respirators)
Pressure Demand

(SCBA)

PD
Supplied-air (Air-line) SA
Supplied-air Abrasive Blast SB
Self-Contained

(SCBA)

SC
Escape (SCBA) ESC
30 CFR 11 respirator
Purple Part 11 HEPA respirator with MSHA/NIOSH emblems
Respirator combination designation and color comparison[lower-alpha 1]
NIOSH protection

abbreviation[ND1]

Color Correlated with Z88.7-2001

(K13.1-1973 revision)?[S1]

1999 NIOSH TB Guide combinations[9] Any of above

chemicals/ Particulates

Gray stripe Wrong color, no stripe
HN/Chloropicrin Yellow with 1/2" blue stripe NIOSH designation does not exist, no stripe, wrong color, actual color for unlisted combinations
Radionuclides Purple/Magenta Yes, under 30 CFR 11 HEPA
AG/HN/CL/OV/AM/CO/

Chloropicrin/ radionuclides/ particulate

Red with

1/2" gray stripe

No stripe needed, combination more than required for color (AG/OV/AM/CO)
AG/AM Green with 1/2" white stripe No stripe, wrong color, actual color for unlisted combinations
AG/OV Yellow Yes, for canisters only
AG/OV/AM Brown Yes, for canisters only
Navy/Marine Field Manual combinations[16][lower-alpha 2] "Acid Gases":

CL/CD/HS/HC/SD/HF

White Combination more than required for color (CL/HC/SD)
"Organic Vapors":

Xylene/Toluene

Brown Within designation color, but wrong color if exclusive
"Basic gases": AM/MA Green Yes
FM Tan Within designation color, but actual color for unlisted combinations
MV Orange NIOSH designation does not exist, wrong color, actual color for unlisted combinations
HEPA Purple Yes
  1. ↑ 1.0 1.1 1.2 1.3 1.4 See the NIOSH pocket guide for additional respirator use guidelines. Breakthrough concentration times can be calculated through the NIOSH MultiVapor tool, or OSHA math models.
  2. ↑ For brevity, only combinations that are different from the TB guide are listed.
Person wearing purple 3M 7093 P100 cartridge filters

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).[S1]

By definition, ANSI Z88.2-2015 considers N100, R100, P100, and HE as HEPA filters.[S2]

Table of TC/BM approval schedules

"TC-84A" redirects here. For information on TC-84A N95-class respirators, see N95 respirator.

Screenshot of the initial NIOSH CEL program with respirator with schedules, and a window with TC-84A respirators open
Screenshot of the NIOSH CEL, dated September 30, 2001, with the six respirator schedules

NIOSH is the current regulator of all the respirators in this schedule, under 42 CFR 84.[C1] 'BM' stands for the US Bureau of Mines, the historical regulator of respirators in the United States.

Approval schedules[16][ND2]
US Code Gas mask
(Canister[ND2]) 		Air-line SCBA Particulate PAPR Chemical
Cartridge
BM BM-14 BM-19 BM-13 BM-21 N/A BM-23
30 CFR 11 TC-14G TC-19C TC-13F TC-21C TC-21C TC-23C
42 CFR 84 (enacted) TC-14G TC-19C TC-13F TC-84A TC-21C TC-23C

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-####.[17] 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-####.[N2]

NIOSH Certified Equipment List

This section is an excerpt from National Institute for Occupational Safety and Health § NIOSH Certified Equipment List[ edit ]

NIOSH rating limitations

NIOSH air filtration ratings do not test the fit of a respirator. Fit testing is required by OSHA for employers when a hazard is present, and voluntary respirator use under Appendix D is not allowed due to the hazard.[18][C5] Rules for fit testing are also defined by ANSI Z88.2. Z88.2 notes that, in Canada, respirator care and fit testing are defined by CSA Z94.4.[S2][S3]

Similar standards

Classic collection efficiency curve with filter collection mechanisms

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

References

  1. ↑ "Counterfeit Respirators / Misrepresentation of NIOSH Approval". May 23, 2024. https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html. 
  2. ↑ NIOSH Guide to the Selection and Use of Particulate Respirators Certified Under 42 CFR 84, January 1996  [scan Wikisource link]
  3. ↑ 3.0 3.1 3.2 Spelce, David; Rehak, Timothy R; Meltzer, Richard W; Johnson, James S (2019). "History of U.S. Respirator Approval (Continued) Particulate Respirators". J Int Soc Respir Prot 36 (2): 37–55. PMID 32572305. 
  4. ↑ A Performance Evaluation of DM and DFM Filter Respirators Certified for Protection Against Toxic Dusts, Fumes, and Mists WORKING DRAFT. CDC NIOSH. 1992. pp. 62–63. 
  5. ↑ "...the lead oxide fume particulate load into a respirator filter is quite large and causes significant plugging of the filter..."[S4]
  6. ↑ "Dust, Mist (DM) respirators are labeled as "permissible respirator for dusts and mists or approved for respiratory protection against dust and mists having a time-weighted average not less than 0.05 milligram per cubic meter or 2 million particles per cubic foot".[ND3]
  7. ↑ "Respirator Trusted-Source Information Section 1: NIOSH-Approved Respirators". Centers for Disease Control and Prevention. January 29, 2018. https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource1quest2.html. 
  8. ↑ "OSHA Technical Manual Section 8VII: Chapter 2 Respiratory Protection Appendix 2-4". https://www.osha.gov/dts/osta/otm/otm_viii/otm_viii_2.html#app_viii:2_4. 
  9. ↑ 9.0 9.1 9.2 9.3 9.4 "TB Respiratory Protection Program In Health Care Facilities Administrator's Guide". U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. September 1999. doi:10.26616/NIOSHPUB99143. https://www.cdc.gov/niosh/docs/99-143/pdfs/99-143.pdf?id=10.26616/NIOSHPUB99143. 
  10. ↑ "NIOSH Pocket Guide - Asbestos". CDC. https://www.cdc.gov/niosh/npg/npgd0041.html. 
  11. ↑ Herring Jr., Ronald N. (1997). "42 CFR Part 84: It's time to change respirators... but how?". Engineer's Digest: 14–23. 
  12. ↑ "Considerations for Optimizing the Supply of Powered Air-Purifying Respirators (PAPRs)" (in en-us). 2020-04-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/powered-air-purifying-respirators-strategy.html. 
  13. ↑ Vanessa, Roberts (Fall 2014). "To PAPR or Not to PAPR?" (in en). Canadian Journal of Respiratory Therapy 50 (3): 87–90. PMID 26078617. 
  14. ↑ "Understanding Respiratory Protection Against SARS" (in en-us). 2020-04-09. https://www.cdc.gov/niosh/npptl/topics/respirators/factsheets/respsars.html. 
  15. ↑ Lee, Byung Uk; Yermakov, Mikhail; Grinshpun, Sergey A. (2005). "Filtering Efficiency of N95- and R95-Type Facepiece Respirators, Dust-Mist Facepiece Respirators, and Surgical Masks Operating in Unipolarly Ionized Indoor Air Environments". Aerosol and Air Quality Research 5 (1): 25–38. doi:10.4209/aaqr.2005.06.0003. https://aaqr.org/articles/aaqr-05-06-oa-0003.pdf. Retrieved 4 July 2024. 
  16. ↑ 16.0 16.1 16.2 "ndustrial Hygiene Field Operations Manual Technical Manual NMCPHC-TM6290.91-2 10 MAY 2021". https://www.med.navy.mil/Portals/62/Documents/NMFA/NMCPHC/root/Industrial%20Hygiene/RESPIRATOR-CLASSIFICATION.pdf?ver=q3PgwJDJRP8F2Ge3pNHzow%3D%3D. 
  17. ↑ "Counterfeit Respirators / Misrepresentation of NIOSH Approval". CDC NIOSH NPPTL. 23 May 2024. https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html. 
  18. ↑ "Fit Test FAQs". 28 December 2021. https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource3fittest.html. 

Selected sources

This section is an excerpt from N95 respirator § Sources from the Federal Register (Titles 29, 30, 42)[ edit ]
This section is an excerpt from Powered air-purifying respirator § Sources from the Federal Register (Titles 29, 42)[ edit ]
This section is an excerpt from N95 respirator § Sources from NIOSH[ edit ]

Works cited on this page

ND1. "LIST OF NIOSH STANDARD PROTECTIONS, CAUTIONS AND LIMITATIONS FOR APPROVAL LABELS". CDC NIOSH. https://www.cdc.gov/niosh/docket/archive/pdfs/niosh-008/0008-100106-handout_7.pdf. 
ND2. "STANDARD APPLICATION PROCEDURES FOR THE CERTIFICATION OF RESPIRATORS". CDC NIOSH. January 2001. http://www.cdc.gov/niosh/pdfs/sap_0101.pdf. 
ND3. Differences and Limitations Between Part 11 Particulate Respirators and Part 84 Particulate Respirators, June 1996 
S1. American National Standard for Color-Coding of Air Purifying Respirator Canisters, Cartridges, and Filters, American Industrial Hygiene Association, ANSI, 2001-05-03, https://webstore.ansi.org/preview-pages/AIHA/preview_ansi-aiha%20Z88.7.pdf, retrieved 3 July 2024 
S2. ANSI/ASSE Z88.2 - 2015 American National Standard Practices for Respiratory Protection, April 2015, https://webstore.ansi.org/preview-pages/ASSE/preview_ANSI+ASSE+Z88.2-2015.pdf?srsltid=AfmBOoqcRAVMMGlzi5vb9BRw7GGDyQE8rcp4zLI1iLD9BE8z4rJYSm3e 
S3. Smith, Simon (March 2024). "Revising the CSA Respirator Standard". https://www.ohcow.on.ca/wp-content/uploads/2024/03/Revising-CanadianRespiratorStandard.pdf. 
S4. Held, Bruce J. (1974), Respiratory Studies for the National Institute for Occupational Safety and Health - July 1, 1973 through June 30, 1974, LANL  (Commons link)

Further reading

Related media at Wikimedia Commons:

  • A Performance Evaluation of DM and DFM Filter Respirators Certified for Protection Against Toxic Dusts, Fumes, and Mists WORKING DRAFT

Texts on Wikisource:

  • Addendum to the NIOSH 42 CFR 84 guide:[N2]
    • NIOSH Service Time Recommendations for P-Series Particulate Respirators
  • Voluntary Program for Acceptance of Applications for the Testing and Evaluation of Full-Facepiece Air Purifying Respirators (APR) for Use Against Chemical, Biological, Radiological and Nuclear (CBRN) Agents
  • Announcement of Public Meeting to Discuss Potential Standards or Guidelines for Respiratory Protective Devices Used to Protect Emergency Response Workers Against Chemical

Papers on Part 11

Papers on Part 84

Template:Breathing apparatus



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