KN95 disposable respirator

KN95 >95%
Respiration Resistance (Pa) Inhale <=350 Exhale <=250
Dead Space 1%
Flammability (s) <=5s

Standard Guide for COVID-19 protective face masks.

The following analysis is an excerpt from a comparison research done by 3M.

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)

As shown in the following summary table, respirators certified as meeting these standards can be expected to function very similarly to one another, based on the performance requirements stated in the standards and confirmed during conformity testing.

One notable comparison point is the flow rates specified by these standards for the inhalation and exhalation resistance tests. Inhalation resistance testing flow rates range from 40 to 160L/min. Exhalation resistance testing flow rates range from 30 to 95 L/min. Some countries require testing to be performed at multiple flow rates, others at only the high or low end of those ranges. Although this appears to suggest that the standards’ requirements for breathing resistance (also called “pressure drop”) differ from each other, it’s important to understand that pressure drop across any filter will naturally be higher at higher flow rates and lower at lower flow rates. Given typical pressure curves for respirator filters, the standards’ various pressure drop requirements are actually quite similar. If one filter is tested at a high flow rate, the pressure drop performance will be relatively high. If that same filter is tested at a low flow rate, the pressure drop performance will be relatively low.

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.

 

 

 

 

 

Korea 1st

DS (Japan

Certification/

N95

 

KN95

 

Class

JMHLW-

Class

(NIOSH-42C

FFP2 (EN

(GB2626-20

P2 (AS/NZ

(KMOEL -

Notification

(Standard)

FR84)

149-2001)

06)

1716:2012)

2017-64)

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

N/A

≤ 8% leakage

≤ 8% leakage

≤ 8% leakage

≤ 8% leakage

Inward Leakage

leakage (TIL)*

 

(arithmetic

(arithmetic

(individual and

(arithmetic

measured and

tested on

 

mean)

mean)

arithmetic

mean)

included in User

human subjects

 

 

 

mean)

 

Instructions

each

 

 

 

 

 

 

performing

 

 

 

 

 

 

exercises

 

 

 

 

 

 

Inhalation

≤ 343 Pa

≤ 70 Pa (at 30

≤ 350 Pa

≤ 70 Pa (at 30

≤ 70 Pa (at 30

≤ 70 Pa

resistance

 

L/min)

 

L/min)

L/min)

(w/valve)

max pressure

 

≤ 240 Pa (at 95

 

≤ 240 Pa (at 95

≤ 240 Pa (at 95

≤ 50 Pa (no

drop

 

L/min)

 

L/min)

L/min)

valve)

 

 

≤ 500 Pa

 

 

 

 

 

 

(clogging)

 

 

 

 

 

Flow rate

 

85 L/min

 

Varied – see above

 

85 L/min

 

Varied – see above

 

Varied – see above

 

40 L/min

Exhalation

≤ 245 Pa

≤ 300 Pa

≤ 250 Pa

≤ 120 Pa

≤ 300 Pa

≤ 70 Pa

resistance -

 

 

 

 

 

(w/valve)

max pressure

 

 

 

 

 

≤ 50 Pa (no

drop

 

 

 

 

 

valve)

Flow rate

85 L/min

160 L/min

85 L/min

85 L/min

160 L/min

40 L/min

Exhalation

Leak rate ≤ 30

N/A

Depressurizatio

Leak rate ≤ 30

visual

Depressurizatio

valve leakage

mL/min

 

n to 0 Pa ≥ 20

mL/min

inspection after

n to 0 Pa ≥ 15

requirement

 

 

sec

 

300 L /min for

sec

 

 

 

 

 

30 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%

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