Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

057

Date of Entry 12/20/2021 

FR Recognition Number

8-581

Standard

IEC 63145-20-20 Edition 1.0 2019-09
Eyewear display -- Part 20-20: Fundamental measurement methods -- Image quality

Scope/Abstract

This standard specifies the standard measurement conditions and measurement methods for determining the image quality of eyewear displays. This document is applicable to non-see-through type virtual reality "VR" goggle) 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.