CDC PPE Standard & Qualification

Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators

Other countries approve respirators for occupational use according to country-specific standards. These products are evaluated using some methods that are similar to those used by NIOSH. Some methods are different but are expected to provide protection similar to NIOSH-approved filtering facepiece and elastomeric respirators. Devices supplied by current NIOSH-approval holders producing respirators under the standards authorized in the listed countries are expected to provide the protection indicated, given that a proper fit is achieved. Therefore, they are considered to be suitable alternatives to provide protection during the COVID-19 response when supplies are short. Within the following tables, the country, conformity assessment standards, standards and guidance documents, acceptable product classification, and NIOSH classification are provided in alphabetical order. All of these respirators have protection factors of at least 10 in the countries listed below, as outlined in the standards and guidance documents specified. 

Respirators Approved Under Standards Used in Other Countries That Are Similar to NIOSH-Approved N95 Filtering Facepiece Respirators
Country Performance Standard Acceptable Product Classification May Be Used in Lieu of NIOSH-Certified Products Classified as
Australia AS/NZS 1716:2012 P2 N95
P3 N99 or lower
Brazil ABNT/NBR 13698:2011 PFF2 N95
PFF3 N99 or lower
People’s Republic of China GB 2626-2006

GB 2626-2019

KN/KP95 N95
KN/KP100 N95
Europe EN 149-2001 P2 N95
P3 N99 or lower
Japan JMHLW-2000 DS/DL2 N95
DS/DL3 N99 or lower
Korea KMOEL-2017-64 Special 1st N95
Mexico NOM-116-2009 N95 N95
R95 R95 or lower
P95 P95 or lower
N99 N99 or lower
R99 R99 or lower
P99 P99 or lower
N100 N100 or lower
R100 R100 or lower
P100 P100 or lower
Respirator-Cartridge Units Approved Under Standards Used in Other Countries That Are Similar to NIOSH-Approved Elastomeric Half-Facepiece Respirators
Country Performance Standard Acceptable Product Classification May Be Used in Lieu of NIOSH-Certified Products Classified as
Australia AS/NZS 1716:2012 P2 N95
P3 N99 or lower
Brazil ABNT/NBR 13694:1996; ABNT/NBR 13697:1996 P2 N95
P3 N99 or lower
People’s Republic of China GB 2626-2006;

GB 2626-2019

KN/KP95 N95
KN/KP100 N95
Europe EN140-1999;

EN 143-2000

P2 N95
P3 N99 or lower
Japan JMHLW-2000 RS/RL2 N95
RS/RL3 N99 or lower
Korea KMOEL-2014-46 Special 1st N95
Mexico NOM-116-2009 N95 N95
R95 R95 or lower
P95 P95 or lower
N99 N99 or lower
R99 R99 or lower
P99 P99 or lower
N100 N100 or lower
R100 R100 or lower
P100 P100 or lower

*Source: Center for Disease Control and Prevention
https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html?CDC_AA_refVal=https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html

Comparing Standard N95s to Surgical N95s

Comparing Standard N95s to Surgical N95s

The following chart demonstrates some key similarities and differences between three respirator models. The 8210 is a standard N95 respirator, while the 1860 and 1870+ are both surgical N95 respirators.

Comparing Standard N95s to Surgical N95s

*Source: Multimedia.3m.com
https://multimedia.3m.com/mws/media/1794572O/surgical-n95-vs-standard-n95-which-to-consider.pdf

Comparison of FFP2, KN95, and N95 and Other Filtering Facepiece Respirator Classes

Filtering facepiece respirators (FFR), which are sometimes called disposable respirators, are subject to various regulatory standards around the world. These standards specify certain required physical properties and performance characteristics in order for respirators to claim compliance with the particular standard. During pandemic or emergency situations, health authorities often reference these standards when making respirator recommendations, stating, for example, that certain populations should use an “N95, FFP2, or equivalent” respirator.

This document is only intended to help clarify some key similarities between such references, specifically to the following FFR performance standards:

N95 (United States NIOSH-42CFR84)

FFP2 (Europe EN 149-2001)

KN95 (China GB2626-2006)

P2 (Australia/New Zealand AS/NZA 1716:2012)

Korea 1st class (Korea KMOEL - 2017-64)

DS (Japan JMHLW-Notification 214, 2018)

Based on this comparison, it is reasonable to consider China KN95, AS/NZ P2, Korea 1st Class, and Japan DS FFRs as “equivalent” to US NIOSH N95 and European FFP2 respirators, for filtering non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g. viruses). However, prior to selecting a respirator, users should consult their local respiratory protection regulations and requirements or check with their local public health authorities for selection guidance.

*Japan JMHLW-Notification 214 requires an Inward Leakage test rather than a TIL test.

Certification/ Class (Standard)

N95 (NIOSH-42C

FR84)

FFP2 (EN 149-2001)

KN95 (GB2626-20 06)

P2 (AS/NZ 1716:2012)

Korea 1st Class (KMOEL - 2017-64)

DS (Japan JMHLW-

Notification 214, 2018)

Filter performance – (must be ≥ X% efficient)

≥ 95%

≥ 94%

≥ 95%

≥ 94%

≥ 94%

≥ 95%

Test agent

NaCl

NaCl and paraffin oil

NaCl

NaCl

NaCl and paraffin oil

NaCl

Flow rate

85 L/min

95 L/min

85 L/min

95 L/min

95 L/min

85 L/min

Total inward leakage (TIL)* – tested on human subjects each performing exercises

N/A

≤ 8% leakage (arithmetic mean)

≤ 8% leakage (arithmetic mean)

≤ 8% leakage (individual and arithmetic mean)

≤ 8% leakage (arithmetic mean)

Inward Leakage measured and included in User Instructions

Inhalation resistance – max pressure drop

≤ 343 Pa

≤ 70 Pa (at 30 L/min)

≤ 240 Pa (at 95 L/min)

≤ 500 Pa (clogging)

≤ 350 Pa

≤ 70 Pa (at 30 L/min)

≤ 240 Pa (at 95 L/min)

≤ 70 Pa (at 30 L/min)

≤ 240 Pa (at 95 L/min)

≤ 70 Pa (w/valve)

≤ 50 Pa (no valve)

Flow rate

85 L/min

Varied – see above

85 L/min

Varied – see above

Varied – see above

40 L/min

Exhalation resistance - max pressure drop

≤ 245 Pa

≤ 300 Pa

≤ 250 Pa

≤ 120 Pa

≤ 300 Pa

≤ 70 Pa (w/valve)

≤ 50 Pa (no valve)

Flow rate

85 L/min

160 L/min

85 L/min

85 L/min

160 L/min

40 L/min

Exhalation valve leakage requirement

Leak rate ≤ 30 mL/min

N/A

Depressurizatio n to 0 Pa ≥ 20 sec

Leak rate ≤ 30 mL/min

visual inspection after 300 L /min for 30 sec

Depressurizatio n to 0 Pa ≥ 15 sec

Force applied

-245 Pa

N/A

-1180 Pa

-250 Pa

N/A

-1,470 Pa

CO2 clearance requirement

N/A

≤ 1%

≤ 1%

≤ 1%

≤ 1%

≤ 1%

*Source: Multimedia.3m.com
https://multimedia.3m.com/mws/media/1791500O/comparison-ffp2-kn95-n95-filtering-facepiece-respirator-classes-tb.pdf

Difference Between Surgical Mask and N95 Respirator

Difference Between Surgical Mask and N95 Respirator

*Source: Center for Disease Control and Prevention
https://www.cdc.gov/niosh/npptl/pdfs/UnderstandDifferenceInfographic-508.pdf

Country Performance Standard Acceptable product classifications Standards/Guidance Documents Protection Factor ≥ 10
CHINA
China GB 2626-2006  KN 100 KP100 KN95 KP95 GB/T 18664—2002 YES
Acceptable product classifications
KN100        
KP100        
KN95        
KP95        
FDA Surgical Masks        
Procedure Masks        
EUROPE
Europe EN 149-2001  FFP3 FFP2 EN 529:2005  YES
Acceptable product classifications
FFP3        
FFP2        
FDA Surgical Masks        
Procedure Masks        
USA
US NIOSH Requirements NIOSH approved 42 CFR 84 N100, P100, R100 N99, P99, R99 N95, P95, R95 OSHA 29CFR1910.134  YES
Acceptable product classifications
N100        
P100        
R100        
N99        
P99        
R99        
N95 3M 8210        
N95 3M 1860        
N95 3M 1870+        
P95        
R95        
FDA Surgical Masks        
Procedure Masks        

FDA inquiry: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm