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Face Mask Regulations and Standards in the EU: An Overview

Apr 02, 2020 · Planning to import medical or protective face masks to the European Union? In this guide, we cover product regulations, EN standards, labeling, certification, and lab testing requirements when importing or manufacturing various types of face masks for the EU. Mentioned Products. 3-ply surgical face masks; 4-ply- surgical face masks

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In general, there are 3 (or sometimes 4) types of commonly used, disposable masks. They are single-use face masks, surgical masks, and respirators. Mask Standards and Effectiveness Bottom Line. Single use masks (normally one layer, very thin) are typically only effective at capturing larger dust particles, but can do so fairly well ...

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3.0 Microns: Bacteria Filtration Efficiency standard (BFE). 0.1 Microns: Particle Filtration Efficiency standard (PFE). 0.3 Microns: Used to represent the most-penetrating particle size (MPPS), which is the most difficult size particle to capture. X: No requirements.. Standards & Effectiveness Overview. Single-use face masks – These are usually a thin single layer mask primarily used for ...

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LEGISLATION AND STANDARDS

EN136 Full Face Masks This standard specifies the requirements for full face masks for use as part of a respiratory protective device. These facepieces may be used in negative pressure systems, powered or supplied air systems . There are three classes of Full Face Masks: • Class 1 - …

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Protective Face Mask Testing & Certification | SGS

Performance standard; Australia: Level 1, Level 2, Level 3: Therapeutic Goods (Medical Devices) Regulations 2002: AS 4381:2015: Brazil-Resolution RDC 185/2001: ABNT NBR 15052:2004: Canada: Level 1, Level 2, Level 3: SOR/98-282: ASTM F2100-19: China: Single-use Medical Face Mask: Regulations for the Supervision and Administration of Medical ...

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US (42CFR84 standard) N95 = European Union (EN149 standard) FFP2 = Australia (Australia, New Zealand AS1716 standard) P2 = China KN95 = Korea KF94 Please be kindly noted, the listed product is produced and distributed abroad and subject to the laws of its country of origin.

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