ISO FDIS 15004-2

Description / Abstract: This part of ISO 15004 specifies f undamental requirements for optical radiation safety for ophthalmic instruments. It is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a light hazards requirement section within their respective International Standards. 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 part of ISO 15004 does not apply to radiation that is intended for treatment of ocular tissues.

NOTE 1 In the case of the treatment beams of therapeutic devices, when conducting risk assessments for nontarget tissues, the limits given in this International Standard can be applied to the treatment beam.

Where vertical (instrument-specific) International Standards contain specific light hazard requirements different from those given in this part of ISO 15004, then those in the vertical International Standard take precedence.

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.

NOTE 2 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 International Standard also take account of the likelihoods that eyes might be dilated and that eyes and heads might be stabilized during ophthalmic examinations. See Reference.[1]