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    I.S. EN 455-2:2015

    Current The latest, up-to-date edition.

    MEDICAL GLOVES FOR SINGLE USE - PART 2: REQUIREMENTS AND TESTING FOR PHYSICAL PROPERTIES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-12-2014

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Dimensions
    5 Strength
    6 Test report
    7 Labelling
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             concerning medical devices

    Abstract - (Show below) - (Hide below)

    Defines requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    ISO 23529:2016 Rubber General procedures for preparing and conditioning test pieces for physical test methods
    EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
    ISO 188:2011 Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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