Ophthalmic Instrument Safety (ANSI Z80.36 and ISO 15004-2)

25 July 2024

Ophthalmic instruments that shine light into the eye, such as the slit lamps used by opticians and optometrists, are subject to standardised safety assessments to prevent damage to the eye from excess irradiance. Two similar standards that prescribe methods and requirements are ANSI Z80.36 and ISO 15004-2.

This documents outlines a method of assessing the safety of some of these devices in a manner compatible with these standards.

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Categories: Certification & Calibration, Medical & Pharmaceutical