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What safety tests have the disposable cushions passed?
The Disposable Cushions for the Insight Pro Goggles have passed the following safety tests as part of our FDA clearance:
- 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