Notification UPDATE: USA N95s vs INTERNATIONAL STANDARDS RE: NIOSH CA 2021-1038
Notification UPDATE: USA N95s vs INTERNATIONAL STANDARDS
RE: NIOSH CA 2021-1038
For Immediate Dissemination September 13th, 2021
This UPDATE to our first notification on August 20th and September 7thavailable in the link below:
Dear Valued End Users, Partners & Respected Worldwide Regulatory Authorities:
Please as we work to recover our certifications from the United States of America (USA) National Institute of Occupational Safety and Health, our company has had many inquiries regarding the difference between the European Certification (European Committee for Standardization/CEN) covered by EN 149: 2001 + A1: 2009 vs the USA N95 covered by NIOSH 42CFR84.
They both do the same thing, and in the USA it is called a N95 whilst in Europe is called a Filtering Face Piece (FFP). The EN 149 standard is recognized as more robust and stringent in efficacy by industry because unlike NIOSH:
1.The European standard uses liquid substances in tests as well as solids
The first difference relates to the polluting substance used when testing the FFP1, FFP2 and FFP3 masks. The European certification system is more in depth here, given that it also carries out testing using paraffin oil, a liquid pollutant, as well as using sodium chloride particles in a solid state.
This is certainly a positive thing, as it means the effectiveness of the masks is tested not only with solid-state pollutants (like a powder), but also, and most importantly, particulates in the form of droplets and aerosols spread by the air.
2.The European standard pays more attention to inhalation resistance/easier to breath
The second immediately apparent difference is the figure for the permitted inhalation resistance.
The average figure for resistance in the European standard is much lower than in the American and Chinese certification systems, meaning that FFP2 masks made following the European standard should ensure greater comfort and durability.
The table below lists the standards set forth by the between the 2 standards:
|Certification/ class (Standard)||N95 (NIOSH-42 CFR84)||FFP2 NR (EN149:2001+A1:2009)|
|Filter performance– (must be ≥ X% efficient)||≥ 95%||≥ 94%|
|Test agent||NaCl||NaCl and Paraffin Oil|
|Flow rate||85 L/min||95 L/min|
|Total inward leakage (TIL)*– tested on human subjects each performing exercises**||N/A||≤ 8% leakage (arithmeticmean)|
|Inhalation resistance – max pressure drop||≤ 343 Pa||≤ 70 Pa (at 30 L/min) ≤ 240 Pa (at 95 L/min)|
|Flow rate||85 L/min||Varied – see above|
|Exhalation resistance - max pressure drop||≤ 245 Pa||≤ 300 Pa|
|Flow rate||85 L/min||160 L/min|
|Exhalation valve leakage requirement||Leak rate ≤ 30 mL/min||N/A|
|Force applied||-245 Pa||N/A|
|CO2 clearance requirement||N/A||≤ 1%|
Backed by Certifications and Testing data:
· Dasheng’s Models are certified and meet EN-149 standard
· Masks manufactured by Dasheng with valid Lot#s are authentic and safe to use
· Aside from USA NIOSH, our masks are Regulatory-Certified and continue to be safely deployed in over 30+ Countries
· Current Test data is available upon request
Our special email address continues to be available should you have any questions in regards to the aforementioned or the authenticity of your mask. Please email us directly firstname.lastname@example.org
Shanghai Dasheng Health Products Manufacture Co., Ltd.
September 13th, 2021