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  • ANSI Z80.7 : 2013

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    OPHTHALMIC OPTICS - INTRAOCULAR LENSES

    Available format(s):  Hardcopy, PDF

    Superseded date:  13-02-2020

    Language(s):  English

    Published date:  01-01-2013

    Publisher:  Optical Laboratories Association

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

    Foreword
    1 Scope and Purpose
    2 Normative references
    3 Vocabulary
    4 Physical requirements
    5 Optical requirements
    6 Mechanical requirements
    7 Biocompatibility requirements
    8 Sterility/package integrity requirements
    9 Shelf-life/shipping requirements
    Annexes
    A - Genotoxicity test
    B - Maximization sensitization test
    C - Ocular Implantation Test
    D - Residual monomer determination - Methyl
        methacrylate
    E - Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to monofocal intraocular lenses (IOLs) whose primary indication is the correction of aphakia.

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

    Committee Z80
    Document Type Standard
    Publisher Optical Laboratories Association
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    ANSI Z80.12 : 2007 : R2017 OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES
    ANSI Z80.13 : 2007 : R2012 OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
    ANSI Z80.13 : 2007 OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
    ANSI Z80.29 : 2015 OPHTHALMICS - ACCOMODATIVE INTRAOCULAR LENSES
    ANSI Z80.13 : 2007 : R2017 OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
    ANSI Z80.30 : 2010 OPHTHALMICS - TORIC INTRAOCULAR LENSES
    ANSI Z80.12 : 2007 OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES

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

    ASTM F 1585 : 2000 Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006)
    AAMI ISO 11134 : 1ED 93 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION
    AAMI TIR19 : 1998 GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
    ANSI/AAMI/ISO 10993-3:2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
    ANSI/AAMI/ISO 11135:2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
    ASTM F 1929 : 2015 : REDLINE Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
    ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    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
    AAMI ISO 14155 : 2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
    AAMI ISO 11137 : 94 AMD 1 2002 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION
    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 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
    ISO 8318:2000 Packaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency
    AAMI ISO 11607 : 2ED 2000 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES
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