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Face Mask Regulations and Standards in the EU: An Overview

Both the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face mask is supplied. The following information must be provided: a) number of this European Standard; b) Type of mask (according to the information in the table).

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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. For respirator masks, China uses the KN standard (e.g. KN95) and the US uses the N standard (e.g. N95).

LEGISLATION AND STANDARDS

certified. European Standards (EN's), which detail performance requirements and test methods, have been developed for almost every type of RPE and are particular to a given type of device. This section details the current EN Standards relevant to the 3M range of RPE . European Standards for Facepieces EN149:2001 Filtering Halfmasks to protect ...

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