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    I.S. EN ISO 11979-7:2014

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR THE CORRECTION OF APHAKIA (ISO 11979-7:2018)

    Available format(s):  Hardcopy, PDF

    Superseded date:  17-06-2018

    Language(s):  English

    Published date:  01-01-2014

    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, definitions and abbreviated terms
    4 Justification for a clinical investigation
    5 Ethical considerations
    6 General requirements
    Annex A (informative) - General elements in the
            clinical investigation of IOLs
    Annex B (informative) - Additional elements for the
            clinical investigation of TIOLs
    Annex C (informative) - Additional elements for the
            clinical investigation of multifocal IOLs
    Annex D (informative) - Additional elements in the
            clinical investigation of accommodating IOLs
    Annex E (informative) - Evaluation of post-operative
            adverse events and visual acuity rates
    Annex F (informative) - Clinical tests
    Annex G (informative) - Statistical methods and
            sample size calculations
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

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

    Development Note Supersedes I.S. EN 13503-7. (07/2006)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Supersedes

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

    ISO 11979-10:2006 Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses
    ISO/TR 22979:2017 Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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