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  • ANSI Z80.29 : 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    OPHTHALMICS - ACCOMODATIVE INTRAOCULAR LENSES

    Available format(s):  Hardcopy, PDF

    Superseded date:  18-12-2020

    Language(s):  English

    Published date:  01-01-2015

    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 (normative) - Optical characterization
    Annex B (informative) - Clinical investigation
    Annex C (informative) - Labeling for AIOLs
    Annex D (informative) - Determination of sample sizes for
            the clinical investigation
    Annex E (informative) - Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to any ocular implant whose primary indication is the correction of aphasia and is designed to provide vision over a continuous range of distances by affecting a change in the mergence power of the eye resulting from the implant design that changes eye optical power or implant position in response to a stimulus.

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

    Document Type Standard
    Publisher Optical Laboratories Association
    Status Superseded
    Superseded By

    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 11979-9:2006 Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
    ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
    ISO 11979-2:2014 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
    ISO 11979-5:2006 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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