NF EN ISO 15004

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.

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.