• BS EN ISO 15004:1998

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Ophthalmic instruments. Fundamental requirements and test methods

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-06-2007

    Language(s):  English

    Published date:  15-04-1998

    Publisher:  British Standards Institution

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

    1 Scope
    2 Normative references
    3 Definitions
    4 Fundamental requirements (for non-active and
        active ophthalmic instruments)
    5 Environmental conditions (for non-active and active
        ophthalmic instruments)
    6 Particular requirements for active ophthalmic
        instruments
    7 Test methods
    8 Information supplied by the manufacturer
    Annex A (normative) Optical radiation hazard
    Annex B (normative) Product-related International
    Standards for ophthalmic instruments
    Annex C (informative) Photometric quantities
    Annex D (informative) Example of information on the
    avoidance of overexposure to potentially hazardous
    optical radiation

    Abstract - (Show below) - (Hide below)

    Defines fundamental requirements for non-invasive, active and non-active ophthalmic instruments. Also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments for use in contact with the globe of the eye.

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

    Committee CH/172/6
    Development Note Supersedes 95/563412 DC (08/2004)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 12867:2010 Ophthalmic instruments Trial frames
    ISO 9022-3:2015 Optics and photonics Environmental test methods Part 3: Mechanical stress
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 9022-2:2015 Optics and photonics Environmental test methods Part 2: Cold, heat and humidity
    ISO 10938:2016 Ophthalmic optics Chart displays for visual acuity measurement Printed, projected and electronic
    ISO 10943:2011 Ophthalmic instruments — Indirect ophthalmoscopes
    ISO 10944:2009 Ophthalmic instruments — Synoptophores
    ISO 9801:2009 Ophthalmic instruments — Trial case lenses
    ISO 10942:2006 Ophthalmic instruments Direct ophthalmoscopes
    ISO 10341:2012 Ophthalmic instruments — Refractor heads
    ISO 10343:2014 Ophthalmic instruments — Ophthalmometers
    ISO 10342:2010 Ophthalmic instruments Eye refractometers
    ISO 10940:2009 Ophthalmic instruments — Fundus cameras
    ISO 12866:1999 Ophthalmic instruments Perimeters
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    ISO 10939:2017 Ophthalmic instruments — Slit-lamp microscopes
    ISO 12865:2006 Ophthalmic instruments Retinoscopes
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