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  • EN ISO 11979-7:2018

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018)

    Available format(s): 

    Withdrawn date:  30-11-2018

    Language(s): 

    Published date:  02-05-2018

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    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)

    ISO 11979-7:2018 specifies 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)

    Committee CEN/TC 170
    Development Note Supersedes EN 13503-7 (05/2006)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Withdrawn
    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
    View more information

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