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There 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.
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The purpose of surgical masks is to protect the patient from aerosols exhaled by the personnel during medical procedures. They are regulated according to the medical devices directive 93/42/EEC (or MDR (EU) 2017/745). The applicable harmonized standard is EN 14683:2019 Medical face masks Requirements and test methods.
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