BS EN ISO 15004-2:2024 - Page 2

Ophthalmic instruments. Fundamental requirements and test methods. Light hazard protection | Status: Current

1 Scope This document 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. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye, as well as to those portions of therapeutic or surgical systems that direct optical radiation into or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes.

NOTE For the purpose of this document, optical radiation relates to the wavelength range of 250 nm to 2 500 nm.

This document does not apply to therapeutic radiation. However, in the case of the treatment beams of therapeutic devices, when conducting risk assessments for non-target tissues, the limits given in this document may be applied to those parts of the treatment beam that strike non-target tissue. Where vertical (instrument-specific) International Standards contain specific light hazard requirements different from those given in ISO 15004‑2, then those in the vertical International Standard take precedence. This document classifies ophthalmic instruments into either Group 1 or Group 2 to distinguish instruments that are non-hazardous from those that are potentially hazardous.