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  • ANSI Z80.12 : 2007 : R2017

    Current The latest, up-to-date edition.

    OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  Optical Laboratories Association

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

    Foreword
    1 Scope and Purpose
    2 Normative references
    3 Definitions
    4 Physical requirements
    5 Optical requirements
    6 Mechanical requirements
    7 Biocompatibility requirements
    8 Sterility/package integrity requirements
    9 Shelf-life and transport stability requirements
    10 Clinical evaluation
    11 Labeling
    Annexes
    Annex A - Optical characterization
    Annex B - Non-ocular implantation test
    Annex C - Clinical investigation
    Annex D - MIOL modifications
    Annex E - Labeling for MIOLs
    Annex F - Determination of sample sizes for the clinical investigation
    Annex G - Functional performance
    Annex H - Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to any ocular implant whose primary indication is the correction of aphakia and whose optic is designed to provide simultaneous distance and near vision.

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

    Document Type Standard
    Product Note Reconfirmed 2017
    Publisher Optical Laboratories Association
    Status Current

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

    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ANSI Z80.7 : 2013 OPHTHALMIC OPTICS - INTRAOCULAR LENSES
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    ISO 11979-4:2008 Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
    ISO 11979-2:2014 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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