Since Coronavirus outbreaks in Europe. FFP2 have been highly demanded from China. Many people don’t know what FFP2 is, FFP2=KN95=N95? Is CE certificate you received valid? How to protect yourself?
What is FFP2?
An FFP mask (Filtering Facepiece Particles, also called respiratory protection mask) is a type of protective mask certified by the European Union that serves to protect against particulates such as dust particles and various viruses in the air.
European Standard EN149 defines the following classes of “filtering half masks”, they are entirely or substantially constructed of filtering material:
|Class||Filter penetration limit(at 95 L/min air flow)||Inward leakage|
|FFP1||Filters at 80% of airborne particles||<22%|
|FFP2||Filters at 94% of airborne particles||<8%|
|FFP3||Filters at 99% of airborne particles||<2%|
FFP2 is considered Personal Protective Equipment (PPE). CE number of the certification body + EN 149: 2009 + FFP2 + acronym (NR or R) should be shown on product
Lately health authorities often reference these standards when making respirator recommendations, stating, for example, that certain populations should use an “N95, FFP2, or KN95” 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)
|Certification/ Class (Standard)|| N95|
– (must be ≥ X% efficient)
|≥ 95%||≥ 94%||≥ 95%|
|Test agent||NaCl||NaCl and paraffin oil||NaCl|
|Flow rate||85 L/min||95 L/min||85 L/min|
|Total inward leakage (TIL)*|
– tested on human subjects each performing exercises
|N/A|| ≤ 8% leakage|
| ≤ 8%|
leakage (arithmetic mean)
– max pressure drop
|≤ 343 Pa||≤ 70 Pa (at 30 L/min)|
≤ 240 Pa (at 95 L/min)
≤ 500 Pa (clogging)
|≤ 350 Pa|
|Flow rate||85 L/min||Varied – see above||85 L/min|
|Exhalation resistance – max pressure drop||≤ 245 Pa||≤ 300 Pa||≤ 250 Pa|
|Flow rate||85 L/min||160 L/min||85 L/min|
|Exhalation valve leakage requirement||Leak rate ≤ 30 mL/min||N/A||Depressurizatio n to 0|
Pa ≥ 20 sec
|Force applied||-245 Pa||N/A||-1180 Pa|
|CO2 clearance requirement||N/A||≤ 1%||≤ 1%|
Is CE certificate you received valid?
In the past two weeks, I have received 60-80 CE certificates, among of them only 5 are valid. Even some factories and agents don’t realize that their certificates are not valid.
Since February, many newcomers start producing masks. In order to export to EU, some factories applied for “CE certificate” from notified body who are not acknowledged by EU.
Here is the link for “suspicious certificate “updated by European Safety Federation on Apr. 7th.for your information.
How to protect yourself?
- Verify all certificates and documents including inspection report
- Company background check
- Oversee and inspect the production. As qualified factories are over demanding. It happens that some factories just take products from around unqualified factories (like newcomers) as their own to sell
- Sign a contract with clear responsibilities and obligations. Make sure once you have dispute that you could have the legal support.
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