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  • ANSI Z80.30 : 2010

    Current The latest, up-to-date edition.

    OPHTHALMICS - TORIC INTRAOCULAR LENSES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2010

    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
    A - Dioptric power and image quality assessment
    B - Guidance on additional clinical requirements
        for toric IOLs
    C - Wavefront sensor test methods for toric IOL
        dioptric power and image quality measurement
    D - Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to any monofocal intraocular lens (IOL) whose primary indication is the reduction of astigmatism either with the correction of aphakia or the modification of the refractive power of a phakic eye.

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

    Committee Z80
    Document Type Standard
    Publisher Optical Laboratories Association
    Status Current
    Supersedes

    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
    ANSI Z80.28 : 2017 OPHTHALMICS - METHODS OF REPORTING OPTICAL ABERRATIONS OF EYES
    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 15367-1:2003 Lasers and laser-related equipment Test methods for determination of the shape of a laser beam wavefront Part 1: Terminology and fundamental aspects
    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
    CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
    ISO 18369-3:2017 Ophthalmic optics — Contact lenses — Part 3: Measurement methods
    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 15367-2:2005 Lasers and laser-related equipment Test methods for determination of the shape of a laser beam wavefront Part 2: Shack-Hartmann sensors
    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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