• I.S. EN ISO 11978:2017

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING (ISO 11978:2017)

    Available format(s):  Hardcopy, PDF

    Superseded date:  16-11-2020

    Language(s):  English

    Published date:  01-01-2017

    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)

    National Foreword
    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Labelling requirements
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of users of contact lenses: the eye care professional and the contact lens wearer.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 18369-1:2017 Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
    ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
    ISO 14729:2001 Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
    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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