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  • BS EN 455-2:2015

    Current The latest, up-to-date edition.

    Medical gloves for single use Requirements and testing for physical properties

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-04-2015

    Publisher:  British Standards Institution

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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.

    Scope - (Show below) - (Hide below)

    This European Standard specifies 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.

    This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

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

    Committee CH/205/3
    Development Note Together with BS EN 455-1 & BS EN 455-3 supersedes BS 4005(1996). Supersedes 99/566715 DC. (09/2005) Supersedes 08/30176484 DC. (11/2009) Supersedes 13/30281501 DC. (05/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    11/30234645 DC : 0 BS 8599-1 - WORKPLACE FIRST AID KITS - PART 1: SPECIFICATION FOR THE CONTENTS OF WORK PLACE FIRST AID KITS
    BS 4005:1996 Specification for single use, sterilized surgical rubber gloves
    BS 8599-2:2014 First aid kits Specification for the contents of motor vehicle first aid kits
    BS 8599-1:2011 Workplace first aid kits Specification for the contents of workplace first aid kits
    13/30284622 DC : 0 BS 8599-2 - MOTOR VEHICLE FIRST AID KITS - PART 2: SPECIFICATION FOR THE CONTENTS OF MOTOR VEHICLE FIRST AID KITS

    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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