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  • 17/30359567 DC : 0

    NA Status of Standard is Unknown

    BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    European foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Classification
    5 Requirements
    6 Marking, labelling and packaging
    Annex A (informative) - Information for users
    Annex B (normative) - Method for in vitro
            determination of bacterial filtration
            efficiency (BFE)
    Annex C (normative) - Method for determination
            of breathability (differential pressure)
    Annex D (informative) - Microbial cleanliness
    Annex ZA (informative) - Relationship between
             this European Standard and the essential
             requirements of Directive 93/42/EEC
             [OJ L 169] aimed to be covered
    Bibliography

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee CH/205/1
    Document Type Draft
    Publisher British Standards Institution
    Status NA

    Standards Referencing This Book - (Show below) - (Hide below)

    EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    EN 149:2001+A1:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    EN 132:1998 Respiratory protective devices - Definitions of terms and pictograms
    EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    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)
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 139:2005 Textiles Standard atmospheres for conditioning and testing
    EN ISO 139:2005/A1:2011 Textiles - Standard atmospheres for conditioning and testing - Amendment 1 (ISO 139:2005/AMD 1:2011)
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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