no decoloring medical mask SGS certification

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    Apr 22, 2020 · Such masks do not provide the same medical benefits or protection than those for which EN 14683 (medical masks) or EN 149 (respiratory protective devices) are applicable. AFNOR SPEC S76 001 masks are not medical devices, and thus are not within the scope of Medical Device Directive 93/42/EEC or Medical Device Regulation (EU) 2017/745.

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  • Face Mask Regulations and Standards in the EUAn Overview

    Tobi Doeringer May 13, 2020 at 12:17 am . Do Type IIR masks need a CE mark assuming they have passed all tests? EN says the requirements on the packaging are onlyBoth 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.

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