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  • ISO 11978:2017

    Current The latest, up-to-date edition.

    Ophthalmic optics — Contact lenses and contact lens care products — Labelling

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French

    Published date:  10-08-2017

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 11978:2017 specifies 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 user of contact lenses: the eye care professional and the contact lens wearer.

    ISO 11978:2017 does not specify the format in which such information shall be provided.

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

    Committee ISO/TC 172/SC 7
    Development Note Supersedes ISO/DIS 11978. (08/2017) NEW CHILD DAM 1 2020 IS NOW ADDED NEW CHILD AMD 1 2020 IS NOW ADDED
    Document Type Standard
    Product Note NEW CHILD DAM 1 2020 IS NOW ADDED NEW CHILD AMD 1 2020 IS NOW ADDED
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    BS EN ISO 14534:2015 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
    I.S. EN ISO 14534:2015 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
    09/30207531 DC : 0 BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
    DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
    UNE-EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)

    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/Amd 1:2010 Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses Amendment 1
    ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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