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ISO 15004-1:2006

Withdrawn

Withdrawn

View Superseded by

Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

06-09-2006

Withdrawn date

04-09-2025

Superseded by

ISO 15004-1:2020

US$96.00
Excluding Tax where applicable

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.

Committee
ISO/TC 172/SC 7
DevelopmentNote
Supersedes ISO/DIS 15004-1. (06/2006) Together with ISO 15004-2, supersedes ISO 15004. (02/2007)
DocumentType
Standard
Pages
8
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

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 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)
EN ISO 9801:2009 Ophthalmic instruments - Trial case lenses (ISO 9801:2009)
NBR ISO 15253 : 2016 OPHTHALMIC OPTICS AND INSTRUMENTS - OPTICAL DEVICES FOR ENHANCING LOW VISION
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
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
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
ISO 10939:2017 Ophthalmic instruments — Slit-lamp microscopes
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
EN 16750:2017 Fixed firefighting systems - Oxygen reduction systems - Design, installation, planning and maintenance
BS EN ISO 15254:2009 Ophthalmic optics and instruments. Electro-optical devices for enhancing low vision
ISO 9801:2009 Ophthalmic instruments — Trial case lenses
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
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
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
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 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 (ISO 10940:2009)
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
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
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)
DIN EN ISO 10939:2017-09 OPHTHALMIC INSTRUMENTS - SLIT-LAMP MICROSCOPES (ISO 10939:2017)
UNE-EN ISO 10943:2012 Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
UNE-EN ISO 8612:2010 Ophthalmic instruments - Tonometers (ISO 8612:2009)
UNE-EN ISO 19980:2012 Ophthalmic instruments - Corneal topographers (ISO 19980:2012)
UNE-EN ISO 10940:2010 Ophthalmic instruments - Fundus cameras (ISO 10940:2009)
UNE-EN ISO 10938:2017 Ophthalmic optics - Chart displays for visual acuity measurement - Printed, projected and electronic (ISO 10938:2016)
UNE-EN ISO 10341:2013 Ophthalmic instruments - Refractor heads (ISO 10341:2012)
UNE-EN ISO 10939:2017 Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)
UNE-EN ISO 10343:2014 Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)
ANSI Z80.10 : 2014 OPHTHALMIC INSTRUMENTS - TONOMETERS
ANSI Z80.37 : 2017 OPHTHALMICS - SLIT-LAMP MICROSCOPES

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

US$96.00
Excluding Tax where applicable