Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

057

Date of Entry 12/20/2021 

FR Recognition Number

8-582

Standard

IEC  63145-22-10 Edition 1.0 2020-01
Eyewear display - Part 22-10: Specific measurement methods for AR type - Optical properties

Scope/Abstract

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   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.