nuoueshop 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.
| 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 |
| 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
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.
*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.
|
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
*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 | ||||