NF EN ISO 15004-1
Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments
This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
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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1 Domaine d'application
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2 Références normatives
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3 Termes et définitions
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4 Exigences fondamentales
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5 Conditions environnementales
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6 Exigences particulières relatives aux instruments ophtalmiques actifs
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7 Méthodes d'essai
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8 Informations fournies par le fabricant
- Annexe A Normes internationales de produits relativesaux instruments ophtalmiques
- Bibliographie
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