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AFNOR Releases General Purpose Mask Standard | SGS

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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Personal Protective Equipment (PPE) - SGS

Personal Protective Equipment (PPE) testing and certification from SGS – ensure your products comply with Regulation, 2016/425. PPE is considered to be any item designed to be worn or held by an individual for protection against one or more safety hazards.

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Face Mask Regulations and Standards in the EU: An 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 provided: a) number of this European Standard; b) Type of mask (according to the information in the table).

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Medical Products - Medical Devices | Smiths Medical

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