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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 8-582
IEC 63145-22-10 Edition 1.0 2020-01
Eyewear display -- Part 22-10: Specific measurement methods for AR type -- Optical properties
This standard specifies the standard measurement conditions and measuring methods for determining the see-through optical properties and imaging quality of augmented reality (AR) eyewear displays. This includes the transmission characteristics and ambient optical performance of the eyewear displays.

Contact-lens type displays and retina direct projection displays are out of the scope of this document.

NOTE 1. See IEC TR 63145-1-1 [1] for eyewear displays, ISO 9241-302:2008, 3.5.45, for see-through types.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Medical devices that incorporate AR or VR headsets or displays for patient and/or provider use.
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.
FDA Technical Contacts
 Ryan Beams
 Chumin Zhao
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Groups (STG)
Materials (primary)
*These are provided as examples and others may be applicable.