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  • DIN EN 14683 E : 2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS

    Available format(s): 

    Superseded date:  03-06-2019

    Language(s): 

    Published date:  12-01-2013

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Classification
    5 Requirements
    6 Labelling and information to be supplied
    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 ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC on
             medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides 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.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

    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
    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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