ISO 15004-1:2006
Withdrawn
View Superseded by
Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments
Hardcopy , PDF
English, French
06-09-2006
04-09-2025
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Withdrawn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 |
| Standards | Relationship |
| NBR ISO 15004-1 : 2015 | Identical |
| NF EN ISO 15004-1 : 2009 | Identical |
| NBN EN ISO 15004-1 : 2009 | Identical |
| NEN EN ISO 15004-1 : 2009 | Identical |
| NS EN ISO 15004-1 : 2009 | Identical |
| I.S. EN ISO 15004-1:2009 | Identical |
| PN EN ISO 15004-1 : 2010 | Identical |
| BS EN ISO 15004-1:2009 | Identical |
| EN ISO 15004-1:2009 | Identical |
| DIN EN ISO 15004-1:2009-07 | Identical |
| BS EN ISO 15004-1:2006 | Equivalent |
| I.S. EN ISO 15004-1:2006 | Equivalent |
| DIN EN ISO 15004-1:2006-09 | Equivalent |
| JIS T 15004-1:2013 | Identical |
| UNE-EN ISO 15004-1:2009 | Identical |
| BS EN ISO 15004-1:2006 | Identical |
| UNE-EN ISO 15004-1:2007 | Identical |
| 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 |