This European Standard specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms. This European Standard is not applicable to masks intended exclusively for the personal protection of staff. NOTE 1 Standards for masks for use as respiratory personal protective equipment are available. NOTE 2 Annex A provides information for the users of medical face masks.
EN 14683:2014 Referenced Document
EN 1041:2008 Information supplied by the manufacturer of medical devices
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EN 1174-2:1996 Sterilization of Medical Devices - Estimation of the Population of Micro-Organisms on Product - Part 2: Guidance
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EN 132:1998 Respiratory protective devices - Definitions of terms and pictograms
EN 149:2001 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking (Incorporates Amendment A1: 2009)
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Remains Current)
ISO 139:2005 Textiles - Standard atmospheres for conditioning and testing
ISO 22609:2004 Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
EN 14683:2014 history
2019EN 14683:2019 Medical face masks - Requirements and test methods
2014EN 14683:2014 Medical face masks - Requirements and test methods
2005EN 14683:2005 Surgical masks - Requirements and test methods