scope:

This part of ISO 15004 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, i.e. all ophthalmic instruments listed in Annex B. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye. Where differences exist between this part of ISO 15004 and the light hazard requirements section of the respective vertical International Standard, then the vertical International Standard shall take precedence.

NOTE The emission limits are based on the International Commission on Non-Ionizing Radiation Protection (ICNIRP) guidelines for human exposure to optical radiation. See Bibliography [1].

This part of ISO 15004 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye.

This part of ISO 15004 classifies ophthalmic instruments into either Group 1 or Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.