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Medical masks have to meet the requirements of the Medical Device legislation and comply with standard EN 14683: Medical face masks - Requirements and test methods and shall have a CE-mark. Currently, it is not necessary to contact a notified body (which is Face Masks Standards - Filtration Effectiveness & Ratings kp100 eu en149 standard medical mask germanyRespirators masks often have a tighter fit around the face than both surgical masks and single-use face masks. Rating Levels of Masks N95, FFP1, FFP2 & FFP3. The ratings are for the filtration level of the face mask, as well as other things. EN 149:2001+A1:2009 / ASTM F2100 / NIOSH. These are standards for face masks.Face Mask Regulations and Standards in the EU: An OverviewApr 02, 2020 · Both the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face mask is supplied. The following information must be provided: a) number of this European Standard; b) Type of mask (according to the information in the table).

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