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  • ANSI Z80.13 : 2007

    Current The latest, up-to-date edition.

    OPHTHALMICS - PHAKIC 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
    10 Clinical investigation plan
    11 Labeling
    Annexes
    Annex A - Mechanical characterization and testing
              of phakic IOLs
    Annex B - Non-ocular implantation test
    Annex C - Ocular implantation test
    Annex D - Clinical guidance
    Annex E - Statistical sample size considerations
    Annex F - Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye. It does not include IOLs used to correct presbyopia or astigmatism.

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

    Committee Z80
    Document Type Standard
    Product Note Reconfirmed 2007
    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 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 8599:1994 Optics and optical instruments Contact lenses Determination of the spectral and luminous transmittance
    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 11979-6:2014 Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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