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Mar 07, 2020 CE certification is issued and certificates are issued by authorized notified bodies. The corresponding standard is EN149. According to the standard, the masks are divided into three categoriesFFP1 / FFP2 and FFP3. Non sterile medical masks are low risk medical devices in the EU medical device classification.
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The European Standard EN149 FFP1 is the rough U.S. equivalent of the N95 NIOSH rating. There is some disconnect since changes to the EU filtration standard are no long based on a most penetrating particle size of 0.3 microns (as in the U.S.) but instead use the smaller 0.25 micron standard.
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