Skip to content
Please enter a keyword to search

  • BS EN ISO 11979-4 : 2008

    Current The latest, up-to-date edition.

    OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2012

    Publisher:  British Standards Institution

    Add To Cart

    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 CH/172/7
    Development Note Supersedes 97/565186 DC (05/2005) Supersedes 07/30169940 DC. (02/2009) 2008 Edition Re-Issued in November 2012 & incorporates AMD 1 2012. Supersedes 11/30227516 DC. (11/2012)
    Document Type Standard
    Publisher British Standards Institution
    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

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective