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FDA recognition of ANSI Z80.36-2016 – Ophthalmic Instruments

Up until now, the FDA recognised ISO 15004-2: 2007 for the evaluation of light hazard associated with ophthalmic instruments including direct and indirect opthalmoscopes, slit lamps, fundus cameras, endoilluminators, and operation microscopes for ocular surgery. From March 31, 2018, declarations of conformity must be made with reference to ANSI Z80.36-2016.

SCHEER: Are LEDs safe?

The European Commission and SCHEER (the Scientific Committee on Health, Environmental and Emerging Risks) have recently published a Preliminary Opinion assessing the potential health risks associated with LED emissions in the general population.

Categories: General & Specialty Lighting, Certification & Calibration

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