Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2007);English version of DIN EN ISO 15004-2:2007-06
This part of ISO 15004 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all oophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within theirrespective International Standards,i.e.all ophthalmic instruments listed in Annex B. It is also applicable to all new and emerging ophthalmic insruments 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 Intertional Standard shall take precedence.
NOTE The emission limits are based on the Internaiional Commission on Non-lonizing Radiation Protection(ICNIRP)guidelines for human exposure to optical radiation.See Bibiliography.
This part of ISO 15004 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended ofr 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.