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It is also common to find the PFE percentage on the mask’s packaging. The ASTM F2299 provides the standard test method for measuring the PFE of the surgical mask. Similar to the BFE, ASTM has also categorized the masks with different PFE into 3 levels: ASTM Level 1 Surgical masks – PFE ≥ 95%@0.1 micron, Fluid resistance 80 mmHg

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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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