• ISO 11980:2012

    Current The latest, up-to-date edition.

    Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations

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

    Language(s):  French, English

    Published date:  14-11-2012

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 11980:2012 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.

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

    Development Note Supersedes ISO/DIS 11980. (11/2012)
    Document Type Standard
    Product Note THIS STANDARD ALSO HAVE CORRECT VERSION FOR EN:2012
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    16/30310659 DC : 0 BS EN ISO 18369-2 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES
    I.S. EN ISO 18369-2:2017 OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES (ISO 18369-2:2017)
    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
    BS EN ISO 18369-2:2017 Ophthalmic optics. Contact lenses Tolerances
    EN ISO 18369-2:2017 Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017)
    ISO 18369-2:2017 Ophthalmic optics — Contact lenses — Part 2: Tolerances
    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 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 9001:2015 Quality management systems — Requirements
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
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