ONORM EN ISO 15004-2:2025

Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2024)

This document specifies basic requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or onto the eye. It is also applicable to all new and developing ophthalmic instruments that direct optical radiation into or onto the eye, as well as to those parts of therapeutic or surgical systems that direct optical radiation into or onto the eye for diagnostic, illumination, measurement, imaging, or targeting purposes. NOTE For the purposes of this document, optical radiation refers to the wavelength range from 250 nm to 2 500 nm. This document is not applicable to therapeutic radiation. However, for the purpose of risk assessment for tissues outside the treatment target, the limits specified in this document may be applied to those parts of the treatment beam from therapeutic devices that impinge on non-target tissue. If vertical (instrument-specific) International Standards contain specific requirements for light hazards that differ from those specified in ISO 15004-2, the requirements specified in the vertical International Standard take precedence. In this document, ophthalmic instruments are assigned to either Group 1 or Group 2 to distinguish between non-hazardous and potentially hazardous instruments.