ISO 15004-2:2007
Current
Current
The latest, up-to-date edition.
Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French
Published date
29-01-2007
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ISO 15004-2:2007 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective International Standards. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye.
ISO 15004-2:2007 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye.
ISO 15004-2:2007 classifies ophthalmic instruments into either Group 1 or a Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.
| DevelopmentNote |
Together with ISO 15004-1, supersedes ISO 15004. (02/2007) DRAFT ISO/DIS 15004-2 has been withdrawn by the publisher. (02/2016)
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| DocumentType |
Standard
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| Pages |
37
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| PublisherName |
International Organization for Standardization
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| NF EN ISO 15004-2 : 2007 | Identical |
| NBN EN ISO 15004-2 : 2007 | Identical |
| NEN EN ISO 15004-2 : 2007 | Identical |
| NS EN ISO 15004-2 : 1ED 2007 | Identical |
| I.S. EN ISO 15004-2:2007 | Identical |
| PN EN ISO 15004-2 : 2010 | Identical |
| SN EN ISO 15004-2 : 2007 | Identical |
| UNI EN ISO 15004-2 : 2007 | Identical |
| BS EN ISO 15004-2:2007 | Identical |
| UNE-EN ISO 15004-2:2007 | Identical |
| EN ISO 15004-2:2007 | Identical |
| DIN EN ISO 15004-2:2014-04 (Draft) | Identical |
| JIS T 15004-2:2013 | Identical |
| DIN EN ISO 15004-2:2007-06 | Identical |
| DIN EN ISO 15752:2010-05 | Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety (ISO 15752:2010) |
| 07/30167441 DC : 0 | BS ISO 15752 - OPHTHALMIC INSTRUMENTS - END ILLUMINATORS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS FOR OPTICAL RADIATION SAFETY |
| 12/30258880 DC : 0 | BS EN 60825-1 ED.3 - SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS |
| 09/30202372 DC : 0 | BS ISO 10936-2 - OPTICS AND PHOTONICS - OPERATION MICROSCOPES - PART 2: LIGHT HAZARD FROM OPERATION MICROSCOPES USED IN OCULAR SURGERY |
| NF EN ISO 15752 : 2010 | OPHTHALMIC INSTRUMENTS - ENDOILLUMINATORS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS FOR OPTICAL RADIATION SAFETY |
| BS EN 60825-1:2014 | Safety of laser products Equipment classification and requirements |
| 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) |
| EN 80601-2-58:2015 | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| NBR ISO 15253 : 2016 | OPHTHALMIC OPTICS AND INSTRUMENTS - OPTICAL DEVICES FOR ENHANCING LOW VISION |
| NBR ISO 15004-1 : 2015 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| ONORM EN ISO 15004-1 : 2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| ISO 16971:2015 | Ophthalmic instruments — Optical coherence tomograph for the posterior segment of the human eye |
| PD IEC/TR 62471-2:2009 | Photobiological safety of lamps and lamp systems Guidance on manufacturing requirements relating to non-laser optical radiation safety |
| BS ISO 10936-2:2010 | Optics and photonics. Operation microscopes Light hazard from operation microscopes used in ocular surgery |
| 11/30233851 DC : 0 | BS EN ISO 10943 - OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES |
| ANSI Z80.11:2012 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| 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 |
| ANSI/AAMI/IEC 80601-2-58:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| UNI EN ISO 15752 : 2010 | OPHTHALMIC INSTRUMENTS - ENDOILLUMINATORS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS FOR OPTICAL RADIATION SAFETY |
| IEC 60601-2-40:2016 | Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment |
| IEC TR 62471-2:2009 | Photobiological safety of lamps and lamp systems - Part 2: Guidance on manufacturing requirements relating to non-laser optical radiation safety |
| 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 10940:2009 | OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS |
| I.S. EN ISO 10943:2011 | OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES |
| EN 60825-1:2014/AC:2017-06 | SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014) |
| I.S. EN ISO 15004-1:2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| EN ISO 15004-1:2009 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) |
| BS EN ISO 15752:2010 | Ophthalmic instruments. Endoilluminators. Fundamental requirements and test methods for optical radiation safety |
| CEI 76-10 : 2011 | PHOTOBIOLOGICAL SAFETY OF LAMPS AND LAMP SYSTEMS - PART 2: GUIDANCE ON MANUFACTURING REQUIREMENTS RELATING TO NON-LASER OPTICAL RADIATION SAFETY |
| BS EN 80601-2-58:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| ISO/TR 20824:2007 | Ophthalmic instruments Background for light hazard specification in ophthalmic instrument standards |
| I.S. EN ISO 15752:2010 | OPHTHALMIC INSTRUMENTS - ENDOILLUMINATORS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS FOR OPTICAL RADIATION SAFETY |
| BS EN ISO 10939:2017 | Ophthalmic instruments. Slit-lamp microscopes |
| UNE-EN ISO 10943:2012 | Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011) |
| UNE-EN 60825-1:2015 | Safety of laser products - Part 1: Equipment classification and requirements |
| ISO 10939:2017 | Ophthalmic instruments — Slit-lamp microscopes |
| I.S. EN 60825-1:2014 | SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS |
| UNI EN ISO 10943 : 2011 | OPHTHALMIC INSTRUMENTS - INDIRECT OPHTHALMOSCOPES |
| UNI EN ISO 10940 : 2009 | OPHTHALMIC INSTRUMENTS - FUNDUS CAMERAS |
| 08/30165284 DC : DRAFT MAR 2008 | BS ISO 10936-2 - OPTICS AND PHOTONICS - OPERATION MICROSCOPES - PART 2: LIGHT HAZARD FROM OPERATION MICROSCOPES USED IN OCULAR SURGERY |
| UNI EN ISO 15004-1 : 2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| 04/30103854 DC : DRAFT JUN 2004 | ISO 15004-1 - OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| ANSI Z80.11 : 2012 : R2017 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| DIN EN ISO 15004-1:2009-07 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006); German version EN ISO 15004-1:2009 |
| ISO 15004-1:2006 | Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments |
| UNE-EN ISO 10939:2017 | Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017) |
| ISO 10943:2011 | Ophthalmic instruments — Indirect ophthalmoscopes |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| ISO 10940:2009 | Ophthalmic instruments — Fundus cameras |
| BS EN ISO 10940:2009 | Ophthalmic instruments. Fundus cameras |
| EN ISO 15752:2010 | Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety (ISO 15752:2010) |
| EN ISO 10939:2017 | Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017) |
| EN ISO 10940:2009 | Ophthalmic instruments - Fundus cameras (ISO 10940:2009) |
| 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 |
| 13/30271473 DC : 0 | BS EN 80601-2-58 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| 15/30287154 DC : 0 | BS EN 60601-2-40 ED 2.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT - PROPOSED HORIZONTAL STANDARD |
| CSA C22.2 No. 80601-2-58 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| ISO 10936-2:2010 | Optics and photonics Operation microscopes Part 2: Light hazard from operation microscopes used in ocular surgery |
| ISO 10942:2006 | Ophthalmic instruments Direct ophthalmoscopes |
| I.S. EN 80601-2-58:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| DIN EN ISO 10940:2010-01 | Ophthalmic instruments - Fundus cameras (ISO 10940:2009) |
| 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) |
| BS EN ISO 10942:2006 | Ophthalmic instruments. Direct ophthalmoscopes |
| ISO 15752:2010 | Ophthalmic instruments Endoilluminators Fundamental requirements and test methods for optical radiation safety |
| BS EN ISO 10943:2011 | Ophthalmic instruments. Indirect ophthalmoscopes |
| BS EN ISO 15004-1:2009 | Ophthalmic instruments. Fundamental requirements and test methods General requirements applicable to all ophthalmic instruments |
| NF EN ISO 15004-1 : 2009 | OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS |
| DIN EN ISO 10939:2017-09 | OPHTHALMIC INSTRUMENTS - SLIT-LAMP MICROSCOPES (ISO 10939:2017) |
| CSA C22.2 No. 60601.2.40 : 2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
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