• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Standards and Guidance Documents Impacted by the Laboratory of Optical Diagnostics

  • FDA Performance Standard for Sunlamp Products (21CFR1040.20) 
  • ANSI/IESNA RP 27.1 Series – Recommended Practice for Photobiological Safety for Lamps and Lamp Systems    
  • IEC 60335-2-27 ed5.0 Household and similar electrical appliances - Safety - Part 2-27: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation 
  • ISO 15004-2 : 2007 Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection 
  • ISO 10940:2009 Ophthalmic instruments -- Fundus cameras 
  • ISO 15752 Ophthalmic instruments -- Endoilluminators -- Fundamental requirements and test methods for optical radiation safety 
  • ISO 10936-2 Optics and photonics -- Operation microscopes -- Part 2: Light hazard from operation microscopes used in ocular surgery 
  • CIE TC 6-48 Typical Minimal Erythema Doses