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SGS has expanded its global network of ISTA accredited test laboratories offering the full suite of ISTA test procedures – including ISTA 6-Amazon, the new Amazon packaging certification standard. China Releases a New National Standard for Technical Specification of Children Mask - GB/T 38880-2020
Surgical masks, including isolating masks, procedure masks, and dental masks, are classified as class II devices by the FDA. For these devices, manufacturers or importers are required to submit 501(k) premarket notification, and obtain FDA clearance, before placing the product in the market.
Nonwovens testing from SGS – comprehensive testing capabilities for nonwoven materials and products. The use of nonwoven materials is ever increasing – from disposable consumer products such as wipes, incontinence products and feminine products to use in clothing, cars, construction, medical supplies, filters, home decorating and more.
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Mask Standards Vary by Country. Each country has their own certification standard for each mask type. For example, Europe uses the EN 14683 standard for surgical masks, whereas China uses the YY 0469 standard. Each standard varies a little by country, however they are broadly similar.
EC Type Examination Certification (Article 10) On-going Assessment of Compliance (Article 11) Factory Audit/ Compliance Testing ABOUT SGS Headquartered in Switzerland, SGS is the world’s leading inspection, verification, testing and certification company. Founded in 1878, SGS is recognised as the global benchmark in quality and integrity.
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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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Disposable respirator masks are usually sold in smaller packs because they’re more expensive and they prevent the inhalation of finer particles than other face masks. They typically come in boxes of 12 to 20 masks. Dust masks and surgical masks are usually available in larger packs of 50 to 125 masks.
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