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What safety tests have the Insight Goggles passed?
The Insight and Insight Pro Goggles have passed the following safety tests as part of our FDA clearance:
- ANSI AAMI ES 60601-1:2005 (R) 2012+AMD1:2012 – Medical Electrical Equipment. Part 1: General requirements for
safety - IEC 60601-1-2:2014 – Medical Electrical Equipment. Part 2: Electrical Safety
- IEC 62471-1:2006 – Photobiological safety of lamps and lamp systems
- ISO 10993-5:2009 – Biological evaluation of medical devices – part 5: tests for in vitro Cytotoxicity
- ISO 10993-10:2010 – Biological evaluation of medical devices – part 10: tests for Skin Sensitization
- ISO 10993-10:2010 – Biological evaluation of medical devices – part 10: tests for Irritation