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  • UNI EN ISO 11979-4 : 2012

    Current The latest, up-to-date edition.

    OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION

    Available format(s): 

    Language(s): 

    Published date:  21-11-2012

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Information provision
    5 Labelling
    6 Package insert
    7 Self-adhesive label
    8 Use of symbols
    9 Additional information
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.

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

    Committee CT 44
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Current
    Supersedes

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

    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    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 980:2008 Symbols for use in the labelling of medical devices
    View more information

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