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  • ISO 15004-1:2006

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  10-06-2020

    Language(s):  English, French

    Published date:  09-06-2006

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.

    ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

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    Development Note Supersedes ISO/DIS 15004-1. (06/2006) Together with ISO 15004-2, supersedes ISO 15004. (02/2007)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By
    Supersedes

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

    16/30339888 DC : 0 BS EN 15004-8 - FIXED FIREFIGHTING SYSTEM - GAS EXTINGUISHING SYSTEMS - PART 8: PHYSICAL PROPERTIES AND SYSTEM DESIGN OF GAS EXTINGUISHING SYSTEMS FOR IG-100 EXTINGUISHANT (ISO 14520-13:2015, MODIFIED)
    PREN 15004-8 : DRAFT 2016 FIXED FIREFIGHTING SYSTEM - GAS EXTINGUISHING SYSTEMS - PART 8: PHYSICAL PROPERTIES AND SYSTEM DESIGN OF GAS EXTINGUISHING SYSTEMS FOR IG-100 EXTINGUISHANT (ISO 14520-13:2015, MODIFIED)
    12/30262710 DC : 0 BS EN ISO 10341 - OPHTHALMIC INSTRUMENTS - REFRACTOR HEADS
    PREN 15004-10 : DRAFT 2016 FIXED FIREFIGHTING SYSTEMS - GAS EXTINGUISHING SYSTEMS - PART 10: PHYSICAL PROPERTIES AND SYSTEM DESIGN OF GAS EXTINGUISHING SYSTEMS FOR IG-541 (ISO 14520-15:2015, MODIFIED)
    EN ISO 19980:2012 Ophthalmic instruments - Corneal topographers (ISO 19980:2012)
    EN ISO 15254:2009 Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision (ISO 15254:2009)
    I.S. EN 15061:2007 SAFETY OF MACHINERY - SAFETY REQUIREMENTS FOR STRIP PROCESSING LINE MACHINERY AND EQUIPMENT
    DIN EN ISO 10944:2010-01 Ophthalmic instruments - Synoptophores (ISO 10944:2009)
    DIN EN ISO 19980 E : 2012 OPHTHALMIC INSTRUMENTS - CORNEAL TOPOGRAPHERS (ISO 19980:2012)
    DIN EN ISO 10342:2010-11 Ophthalmic instruments - Eye refractometers (ISO 10342:2010)
    DIN EN ISO 9801:2010-04 Ophthalmic instruments - Trial case lenses (ISO 9801:2009)
    BS EN ISO 10343:2014 Ophthalmic instruments. Ophthalmometers
    I.S. EN ISO 10938:2016 OPHTHALMIC OPTICS - CHART DISPLAYS FOR VISUAL ACUITY MEASUREMENT - PRINTED, PROJECTED AND ELECTRONIC (ISO 10938:2016)
    I.S. EN ISO 10939:2017 OPHTHALMIC INSTRUMENTS - SLIT-LAMP MICROSCOPES (ISO 10939:2017)
    EN ISO 10942:2006 Ophthalmic instruments - Direct ophthalmoscopes (ISO 10942:2006)
    DIN EN ISO 15254:2009-10 Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision (ISO 15254:2009)
    DIN EN ISO 19980:2012-07 Ophthalmic instruments - Corneal topographers (ISO 19980:2012)
    UNI EN ISO 15254 : 2009 OPHTHALMIC OPTICS AND INSTRUMENTS - ELECTRO-OPTICAL DEVICES FOR ENHANCING LOW VISION
    EN ISO 9801:2009 Ophthalmic instruments - Trial case lenses (ISO 9801:2009)
    UNI EN ISO 19980 : 2012 OPHTHALMIC INSTRUMENTS - CORNEAL TOPOGRAPHERS
    NBR ISO 15253 : 2016 OPHTHALMIC OPTICS AND INSTRUMENTS - OPTICAL DEVICES FOR ENHANCING LOW VISION
    ONORM EN ISO 10943 : 2011 OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES (ISO 10943:2011)
    PREN 15004-9 : DRAFT 2016 FIXED FIREFIGHTING SYSTEM - GAS EXTINGUISHING SYSTEMS - PART 9: PHYSICAL PROPERTIES AND SYSTEM DESIGN OF GAS EXTINGUISHING SYSTEMS FOR IG-55 EXTINGUISHANT (ISO 14520-14:2015, MODIFIED)
    ISO 16971:2015 Ophthalmic instruments Optical coherence tomograph for the posterior segment of the human eye
    11/30233851 DC : 0 BS EN ISO 10943 - OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES
    BS EN 16750:2017 Fixed firefighting systems. Oxygen reduction systems. Design, installation, planning and maintenance
    PD ISO/TR 20824:2007 Ophthalmic instruments. Background for light hazard specification in ophthalmic instrument standards
    05/30114976 DC : DRAFT FEB 2005 ISO 10943 - OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES
    I.S. EN 16750:2017 FIXED FIREFIGHTING SYSTEMS - OXYGEN REDUCTION SYSTEMS - DESIGN, INSTALLATION, PLANNING AND MAINTENANCE
    BS EN 15061 : 2007 SAFETY OF MACHINERY - SAFETY REQUIREMENTS FOR STRIP PROCESSING LINE MACHINERY AND EQUIPMENT
    ANSI Z80.37 : 2017 OPHTHALMICS - SLIT-LAMP MICROSCOPES
    DIN EN ISO 9801 E : 2010 OPHTHALMIC INSTRUMENTS - TRIAL CASE LENSES
    BS EN ISO 12865:2006 Ophthalmic instruments. Retinoscopes
    BS EN ISO 12867:2010 Ophthalmic instruments. Trial frames
    BS EN ISO 12866 : 1999 OPHTHALMIC INSTRUMENTS - PERIMETERS
    UNE-EN ISO 10940:2010 Ophthalmic instruments - Fundus cameras (ISO 10940:2009)
    I.S. EN ISO 10942:2006 OPHTHALMIC INSTRUMENTS - DIRECT OPHTHALMOSCOPES
    I.S. EN ISO 10343:2014 OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS (ISO 10343:2014)
    I.S. EN ISO 8612:2009 OPHTHALMIC INSTRUMENTS - TONOMETERS
    I.S. EN ISO 9801:2009 OPHTHALMIC INSTRUMENTS - TRIAL CASE LENSES
    I.S. EN ISO 10940:2009 OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS
    I.S. EN ISO 12867:2010 OPHTHALMIC INSTRUMENTS - TRIAL FRAMES
    I.S. EN ISO 12865:2006 OPHTHALMIC INSTRUMENTS - RETINOSCOPES
    I.S. EN ISO 10943:2011 OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES
    I.S. EN ISO 15254:2009 OPHTHALMIC OPTICS AND INSTRUMENTS - ELECTRO-OPTICAL DEVICES FOR ENHANCING LOW VISION
    I.S. EN ISO 10342:2010 OPHTHALMIC INSTRUMENTS - EYE REFRACTOMETERS
    I.S. EN ISO 10944:2009 OPHTHALMIC INSTRUMENTS - SYNOPTOPHORES
    I.S. EN ISO 10341:2012 OPHTHALMIC INSTRUMENTS - REFRACTOR HEADS (ISO 10341:2012)
    DIN EN ISO 10343:1999-07 OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS (ISO 10343:2014)
    I.S. EN ISO 19980:2012 OPHTHALMIC INSTRUMENTS - CORNEAL TOPOGRAPHERS (ISO 19980:2012)
    16/30339879 DC : 0 BS EN 15004-10 - FIXED FIREFIGHTING SYSTEMS - GAS EXTINGUISHING SYSTEMS - PART 10: PHYSICAL PROPERTIES AND SYSTEM DESIGN OF GAS EXTINGUISHING SYSTEMS FOR IG-541 (ISO 14520-15:2015, MODIFIED)
    DIN EN 15061:2009-05 Safety of machinery - Safety requirements for strip processing line machinery and equipment (includes Amendment A1:2008)
    14/30254042 DC : 0 BS EN ISO 15004-2 - OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 2: LIGHT HAZARD PROTECTION
    ISO/TR 20824:2007 Ophthalmic instruments Background for light hazard specification in ophthalmic instrument standards
    DIN EN ISO 12865:2006-10 Ophthalmic instruments - Retinoscopes (ISO 12865:2006)
    DIN EN ISO 12866:2009-03 OPHTHALMIC INSTRUMENTS - PERIMETERS
    BS EN ISO 10939:2017 Ophthalmic instruments. Slit-lamp microscopes
    UNE-EN ISO 10943:2012 Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
    UNE-EN ISO 8612:2010 Ophthalmic instruments - Tonometers (ISO 8612:2009)
    ISO 10939:2017 Ophthalmic instruments — Slit-lamp microscopes
    UNI EN ISO 10341 : 2013 OPHTHALMIC INSTRUMENTS - REFRACTOR HEADS
    UNI EN ISO 10343 : 2014 OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS
    UNI EN ISO 10342 : 2010 OPHTHALMIC INSTRUMENTS - EYE REFRACTOMETERS
    UNI EN ISO 10944 : 2009 OPHTHALMIC INSTRUMENTS - SYNOPTOPHORES
    UNI EN 15061 : 2009 SAFETY OF MACHINERY - SAFETY REQUIREMENTS FOR STRIP PROCESSING LINE MACHINERY AND EQUIPMENT
    UNI EN ISO 10943 : 2011 OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES
    UNI EN ISO 9801 : 2010 OPHTHALMIC INSTRUMENTS - TRIAL CASE LENSES
    UNI EN ISO 12867 : 2010 OPHTHALMIC INSTRUMENTS - TRIAL FRAMES
    UNI EN ISO 10940 : 2009 OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS
    UNI EN ISO 8612 : 2009 OPHTHALMIC INSTRUMENTS - TONOMETERS
    16/30339876 DC : 0 BS EN 15004-9 - FIXED FIREFIGHTING SYSTEM - GAS EXTINGUISHING SYSTEMS - PART 9: PHYSICAL PROPERTIES AND SYSTEM DESIGN OF GAS EXTINGUISHING SYSTEMS FOR IG-55 EXTINGUISHANT (ISO 14520-14:2015, MODIFIED)
    08/30173112 DC : DRAFT AUG 2008 BS EN ISO 8612 - OPHTHALMIC INSTRUMENTS - TONOMETERS
    DIN EN 15061 E : 2009 SAFETY OF MACHINERY - SAFETY REQUIREMENTS FOR STRIP PROCESSING LINE MACHINERY AND EQUIPMENT
    EN 16750:2017 Fixed firefighting systems - Oxygen reduction systems - Design, installation, planning and maintenance
    DIN EN ISO 8612 E : 2010 OPHTHALMIC INSTRUMENTS - TONOMETERS
    BS EN ISO 15254:2009 Ophthalmic optics and instruments. Electro-optical devices for enhancing low vision
    ISO 9801:2009 Ophthalmic instruments — Trial case lenses
    UNE-EN ISO 10939:2017 Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)
    ISO 10944:2009 Ophthalmic instruments — Synoptophores
    ISO 10943:2011 Ophthalmic instruments — Indirect ophthalmoscopes
    ISO 10341:2012 Ophthalmic instruments — Refractor heads
    BS EN ISO 9801:2009 Ophthalmic instruments. Trial case lenses
    ISO 10342:2010 Ophthalmic instruments Eye refractometers
    ISO 12865:2006 Ophthalmic instruments Retinoscopes
    ISO 12867:2010 Ophthalmic instruments Trial frames
    ISO 15254:2009 Ophthalmic optics and instruments Electro-optical devices for enhancing low vision
    BS EN ISO 8612:2009 Ophthalmic instruments. Tonometers
    UNE-EN ISO 19980:2012 Ophthalmic instruments - Corneal topographers (ISO 19980:2012)
    ISO 10940:2009 Ophthalmic instruments — Fundus cameras
    BS EN ISO 10342:2010 Ophthalmic instruments. Eye refractometers
    BS EN ISO 10940:2009 Ophthalmic instruments. Fundus cameras
    UNE-EN ISO 10341:2013 Ophthalmic instruments - Refractor heads (ISO 10341:2012)
    ISO 8612:2009 Ophthalmic instruments — Tonometers
    ISO 10938:2016 Ophthalmic optics Chart displays for visual acuity measurement Printed, projected and electronic
    ISO 12866:1999 Ophthalmic instruments Perimeters
    UNE-EN ISO 10343:2014 Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)
    BS EN ISO 10341:2012 Ophthalmic instruments. Refractor heads
    EN 15061:2007+A1:2008 Safety of machinery - Safety requirements for strip processing line machinery and equipment
    EN ISO 10938:2016 OPHTHALMIC OPTICS - CHART DISPLAYS FOR VISUAL ACUITY MEASUREMENT - PRINTED, PROJECTED AND ELECTRONIC (ISO 10938:2016)
    EN ISO 12866:1999/A1:2008 Ophthalmic instruments - Perimeters - Amendment 1 (ISO 12866:1999/Amd1:2008)
    EN ISO 10939:2017 Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)
    EN ISO 10944:2009 Ophthalmic instruments - Synoptophores (ISO 10944:2009)
    EN ISO 10341:2012 Ophthalmic instruments - Refractor heads (ISO 10341:2012)
    EN ISO 12867:2010 Ophthalmic instruments - Trial frames (ISO 12867:2010)
    EN ISO 10342:2010 Ophthalmic instruments - Eye refractometers (ISO 10342:2010)
    EN ISO 10940 : 2009 OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS
    EN ISO 10343:2014 Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)
    EN ISO 12865:2006 Ophthalmic instruments - Retinoscopes (ISO 12865:2006)
    EN ISO 10943:2011 Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
    08/30138766 DC : DRAFT MAR 2008 BS EN ISO 10940 - OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS
    05/30114972 DC : DRAFT FEB 2005 ISO 10942 - OPHTHALMIC INSTRUMENTS - DIRECT OPHTHALMOSCOPES
    14/30285182 DC : 0 BS EN ISO 10938 - OPHTHALMIC OPTICS - CHART DISPLAYS FOR VISUAL ACUITY MEASUREMENTS - PRINTED, PROJECTED AND ELECTRONIC
    ANSI Z80.10 : 2014 OPHTHALMIC INSTRUMENTS - TONOMETERS
    07/30156568 DC : DRAFT AUG 2007 BS ISO 12866 AMD1 - OPHTHALMIC INSTRUMENTS - PERIMETERS
    12/30253298 DC : 0 BS EN ISO 10343 - OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS
    05/30125283 DC : DRAFT MAY 2005 EN ISO 12865 - OPHTHALMIC INSTRUMENTS - RETINOSCOPES
    ISO 10942:2006 Ophthalmic instruments Direct ophthalmoscopes
    DIN EN ISO 10940:2010-01 Ophthalmic instruments - Fundus cameras (ISO 10940:2009)
    DIN EN ISO 10341:2013-04 Ophthalmic instruments - Refractor heads (ISO 10341:2012)
    DIN EN ISO 10939:2016-10 (Draft) OPHTHALMIC INSTRUMENTS - SLIT-LAMP MICROSCOPES (ISO 10939:2017)
    DIN EN ISO 10943:2011-11 Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
    DIN EN ISO 10343:2014-10 OPHTHALMIC INSTRUMENTS - OPHTHALMOMETERS (ISO 10343:2014)
    BS EN ISO 10942:2006 Ophthalmic instruments. Direct ophthalmoscopes
    UNE-EN ISO 10938:2017 Ophthalmic optics - Chart displays for visual acuity measurement - Printed, projected and electronic (ISO 10938:2016)
    BS EN ISO 10938:1998 Ophthalmic instruments. Chart projectors
    BS EN ISO 19980:2012 Ophthalmic instruments. Corneal topographers
    ISO 10343:2014 Ophthalmic instruments — Ophthalmometers
    BS EN ISO 10943:2011 Ophthalmic instruments. Indirect ophthalmoscopes
    BS EN ISO 10944:2009 Ophthalmic instruments. Synoptophores
    ISO 19980:2012 Ophthalmic instruments Corneal topographers
    DIN EN ISO 8612:2010-02 Ophthalmic instruments - Tonometers (ISO 8612:2009)
    ONORM EN ISO 15254 : 2009 OPHTHALMIC OPTICS AND INSTRUMENTS - ELECTRO-OPTICAL DEVICES FOR ENHANCING LOW VISION
    DIN EN ISO 10939:2017-09 OPHTHALMIC INSTRUMENTS - SLIT-LAMP MICROSCOPES (ISO 10939:2017)

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

    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
    IEC 60695-2-11:2014 Fire hazard testing - Part 2-11: Glowing/hot-wire based test methods - Glow-wire flammability test method for end-products (GWEPT)
    ISO 15004-2:2007 Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection
    IEC 60695-2-10:2013 Fire hazard testing - Part 2-10: Glowing/hot-wire based test methods - Glow-wire apparatus and common test procedure
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
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