Light Hazard Measurement on an Ophthalmic Instrument

Melo, David; Vieira, Pedro; Soares, Filipe

doi:10.5220/0007575800870098

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A Safety Studies 1) Eye Safety Tests1

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2021

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“…As the light spectrum used by EFS could potentially harm the patients, we conducted external laboratory tests to assess the safety of the device. The test methodology described by Melo et al in [47] was based on the requirements of ISO 15004-2 on light hazard protection and ISO 10940 on fundus cameras (including safety), currently accepted and applied to medical devices that treat or diagnose ocular pathologies. The procedure included: (1) Measuring the emission spectrum of each LED with a spectrometer; (2) Measuring the power emitted by each LED through a Power Photodiode; (3) Crossing the two measurements made in the previous steps to obtain the distribution of the power emitted by the wavelength of each LED; and (4) checking the measured values against the standard's limits.…”

Section: A Safety Studies 1) Eye Safety Testsmentioning

confidence: 99%