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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 12-282
Standard
ISO  12609-1 First edition 2013-07-15
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
Scope/Abstract
ISO 12609-1:2013 specifies performance and labelling of eye protectors used for ILS equipment used on humans and animals for cosmetic and medical applications against excessive exposure to optical radiation in the spectral range 250 nm to 3 000 nm, with the exception of laser radiation.

ISO 12609-1:2013 provides a specification for an eye protector expected to cope with the majority of applications. A more rigorous procedure for determining appropriate eye protection against spectral outputs from ILS equipment is described in the annexes.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.6070 Activator, Ultraviolet, For Polymerization Class 2 EBZ
§886.4750 Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Class 1 HOY
§886.4750 Collagen Corneal Shield Class 1 MOE
§892.6500 Shield, Eye, Radiological Class 1 IWS
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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