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Face Mask Regulations and Standards in the EUAn Overview
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 provideda) number of this European Standard; b) Type of mask (according to the information in the table).
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EN 455 part 1,2,3 and 4Directive 93/42/EEC concerning Medical Devices The Directive 93/42/EEC on medical devices (MDD 93/42), is a document that sets out the general criteria to be used in the design and construction of certain categories of medical devices.
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Protection class FFP3 respirator masks offer maximum protection from breathing air pollution. The total leakage may amount to a maximum of 5% and they must filter 99% of all particles measuring up to 0.6 m. This kind of mask also filters poisonous, oncogenic and radioactive particles. Protection class FFP3 masks are used in working
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