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  • ANSI Z80.27 : 2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - IMPLANTABLE GLAUCOMA DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  18-02-2020

    Language(s):  English

    Published date:  01-01-2014

    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 Design attributes and evaluation
    5 Physical and mechanical requirements
    6 Biocompatiblity requirements
    7 Sterility/package integrity requirements
    8 Shelf-life and transport stability requirements
    9 Additional requirements
    10 Clinical evaluation
    11 Labeling
    Annexes
    Annex A (informative) - Examples of practices for in-Vitro
            flow characteristics of aqueous shunt type of implantable
            glaucoma devices
    Annex B (informative) - Ocular implantation test
    Annex C (informative) - Guidance on clinical study
            design for implantable glaucoma devices with
            refractory glaucoma indications
    Annex D (informative) - Guidance on clinical study design
            for implantable glaucoma devices with nonrefractory
            glaucoma indications
    Annex E (informative) - Evaluations, Methodology and Adverse events
    Annex F (informative) Statistical Sample Size Considerations for
            nonrefractory glaucoma devices
    Annex G (informative) - Recommended Analyses of Data from
            the Clinical Investigation
    Annex H (informative) - Labeling for Implantable Glaucoma
            devices
    Annex I (informative) - Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to devices that are implanted in the eye to treat glaucoma by facilitating aqueous outflow. The standard excludes glaucoma devices whose effect depends upon metabolic and/or pharmacologic mechanisms.

    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    Status Superseded
    Superseded By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)

    AAMI ISO 11134 : 1ED 93 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION
    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ASTM D 4169 : 2016 : REDLINE Standard Practice for Performance Testing of Shipping Containers and Systems
    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 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 14630:2012 Non-active surgical implants General requirements
    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 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 11979-5:2006 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
    ISO 11979-6:2014 Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing
    ISO 8318:2000 Packaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency
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