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Jul 24, 2020 · Unlike surgical face masks, respirator masks are regulated as PPE. In Europe, the masks are split into three filtering face piece (FFP) protection categories: FFP1, FFP2 and FFP3, with the latter conforming to the highest standards.Face Mask Regulations and Standards in the EU: An Apr 02, 2020 · Generally speaking, surgical masks are classified as a Class I medical device. However, if your masks are sterile, then they classified as Class I (sterile) . Also, note that according to the 2007 amendment of the Directive , when the mask is designed to protect both the patient and the wearer, it shall comply with the PPE Directive as well.Comparison of Mask Standards, Ratings, and Filtration ffp3 la certification surgical mask in germanyThis includes ratings such as N95, KN95, FFP1, FFP2 and FFP3. Mask Standards Vary by Country. Each country has their own certification standard for each mask type. For example, Europe uses the EN 14683 standard for surgical masks, whereas China uses the YY 0469 standard. Each standard varies a little by country, however they are broadly similar.

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