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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 057 Date of Entry 12/20/2021 
FR Recognition Number 8-580
Standard
IEC  63145-20-10 Edition 1.0 2019-08
Eyewear display - Part 20-10: Fundamental measurement methods - Optical properties
Scope/Abstract
This standard specifies the standard measurement conditions and measurement methods for determining the optical properties of eyewear displays. This document applies to non-see-through type (virtual reality "VR" goggles) and see-through type (augmented reality "AR" glasses) eyewear displays using virtual image optics.

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
  FDA/OC/CDRH/OSEL/DIDSR
  240-402-3216
  ryan.beams@fda.hhs.gov
 Chumin Zhao
  FDA/OC/CDRH/OSEL/DIDSR
  --
  chumin.zhao@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Groups (STG)
Materials (primary)
Radiology
*These are provided as examples and others may be applicable.
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