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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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For the medical surgical mask production process, TM120 + MUW6(manual earloop welding) and TM120 + AUW60(auto earloop welding) have the exact same machine for producing the mask body part, the main difference is the ultrasonic welding machine, MUW6 needs the cutting machine(ECM) for cutting the earloops and manual operation ultrasonic welding machine to connect the earloops to the mask
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SGS is the world's leading inspection, verification, testing and certification company. Operating in Australia since 1949, SGS now has a network of more than 50 offices and laboratories with over 1,700 employees. Our core service activities cover all industry sectors and touch the products and services that consumers around the world rely on