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U.S. Department of Health and Human Services

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Standards and Guidance Documents Impacted by the Laboratory of Optical Therapeutics and Medical Nanophotonics

  • International Standard IS0 11979: Ophthalmic Implants-Intraocular Lenses - Optical Properties and Test Methods
  • American National Standard ANSI Z80: Multiple Standards - Intraocular Lenses (Z80.7), Multifocal Intraocular Lenses (Z80.12), Phakic Intraocular Lenses (Z80.13), Accommodative Intraocular Lenses (Z80.29), Toric Intraocular Lenses (Z80.30)
  • International Standard ISO 8600-1: Medical Endoscopes and Endotherapy Devices
  • International Standard ISO 15004: Ophthalmic Instruments - Fundamental Requirements and Test Methods
  • American National Standard ANSI Z136 Safe Use of Lasers
  • International Standard IEC 60825: Safety of Laser Products
  • Draft Guidance for Industry and FDA Staff: Evaluation of Optical Radiation Hazard from Endoscopic Devices with Scanning/Focused Lights

 

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