scope:

This standard specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all current 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.

This standard does not apply to radiation that is intended for treatment of ocular tissues.

NOTE 1 to entry: Concerning the treatment beams of therapeutic devices, when risk assessments for non-target tissues are conducted, the limits given in this Standard can be applied to the treatment beam.

This standard 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.

NOTE 1 to entry: The emission limits are based on the International Commission on Non-Ionizing Radiation Protection (ICNIRP) guidelines for human exposure to optical radiation. The limits and guidelines in this standard also account for the likelihood that eyes may be dilated and that eyes and head may be stabilized during ophthalmic examinations. See [1] in Annex H, Bibliography.