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  • ANSI Z80.11 : 2012 : R2017

    Current The latest, up-to-date edition.

    OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING

    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 Mechanical, thermal, and environmental requirements
    5 Safety requirements
    6 Optical requirements
    7 System control and performance
    8 Clinical evaluation
    9 Test methods
    10 Accompanying documents
    11 Marking
    Annexes
    Annex A - Spectral weighting function for ultraviolet radiation
              hazard analysis
    Annex B - Methods for system calibration
    Annex C - Characterization of laser ablation beams and treatment
              patterns
    Annex D - Guidance on clinical study design of refractive
              procedures that use laser systems for corneal reshaping
    Annex E - Statistical sample size considerations
    Annex F - Presentation of results of clinical studies
    Annex G - Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to any laser system whose primary intended use is to alter the shape of the cornea through the removal of corneal tissue, resulting in the improvement of visual performance.

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

    Committee Z80
    Document Type Standard
    Product Note Reconfirmed 2017
    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
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 13852:1996 Safety of machinery Safety distances to prevent danger zones being reached by the upper limbs
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    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
    IEC 60601-2-22:2007+AMD1:2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ANSI Z136.1 : 2014 SAFE USE OF LASERS
    IEC TR 60825-8:2006 Safety of laser products - Part 8: Guidelines for the safe use of laser beams on humans
    ISO 8612:2009 Ophthalmic instruments — Tonometers
    ISO 13853:1998 Safety of machinery Safety distances to prevent danger zones being reached by the lower limbs
    ISO 10936-2:2010 Optics and photonics Operation microscopes Part 2: Light hazard from operation microscopes used in ocular surgery
    ANSI Z136.3 : 2011 SAFE USE OF LASERS IN HEALTH CARE
    ISO 15004-2:2007 Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection
    ISO 12100-2:2003 Safety of machinery Basic concepts, general principles for design Part 2: Technical principles
    ISO 13854:2017 Safety of machinery — Minimum gaps to avoid crushing of parts of the human body
    ISO 12100-1:2003 Safety of machinery Basic concepts, general principles for design Part 1: Basic terminology, methodology
    ISO 13850:2015 Safety of machinery Emergency stop function Principles for design
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    ISO 13849-1:2015 Safety of machinery — Safety-related parts of control systems — Part 1: General principles for design
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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