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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.Face Mask Regulations and Standards in the EU: An OverviewThere are several accredited testing companies that provide MDD testing services for face mask products, which include Bureau Veritas, SGS, Intertek, and TUV. Quality Management System (ISO 13485) If your surgical masks are classified as sterile, then the MDD requires that the manufacturer has a quality management system (QMS) in place.Update on Novel Coronavirus | SGSSGS is the worlds leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

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