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  • UNI EN ISO 11979-7 : 2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS

    Available format(s): 

    Superseded date:  30-08-2022

    Language(s): 

    Published date:  01-01-2015

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Justification for a clinical investigation
    5 Ethical considerations
    6 General requirements
    Annex A (informative) - Elements of a clinical
            investigation
    Annex B (informative) - Evaluation of post-operative
            adverse event and visual acuity rates
    Annex C (informative) - Additional elements for toric
            IOLs
    Annex D (informative) - Additional elements for
            accommodating IOLs
    Annex E (informative) - Clinical tests
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines particular requirements for clinical investigations for posterior and anterior chamber intraocular lenses (IOLs).

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

    Committee U42.00.06
    Development Note Supersedes UNI EN 13503-7. (07/2006)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    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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