ISO 15004-2 specifies the basic requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation to or to the eye and have a specific light hazard requirement section in their relevant International Standards. It can also be applied to all new and emerging ophthalmic instruments that direct optical radiation to or from the eye.
ISO 15004-2 does not apply to radiation for the treatment of the eye that exceeds the limits specified in ISO 15004.
ISO 15004-2 classifies ophthalmic instruments as group 1 or group 2 to distinguish non-hazardous instruments from potentially dangerous ones.
Ophthalmic instruments shall be designed in such a way that energy at all wavelengths is reduced as much as possible in accordance with the intended use of the instrument.
If another device is used in conjunction with an ophthalmic device, the coupling system must not reduce the optical radiation safety of both devices and the optical radiation hazards of the combined system must not exceed the levels given in this part of ISO 15004.
Scanners will be evaluated using pulsed device criteria when their scan length is greater than the diameter of the measuring aperture. Where the scan length is less than or equal to the measurement aperture, it will be evaluated using continuous wave criteria.
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