Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

062

Date of Entry 05/29/2024

FR Recognition Number

12-360

Standard

IEC 63145-10 Edition 1.0 2023-09
Eyewear display - Part 10: Specifications

Scope/Abstract

This part of IEC 63145 establishes specifications and requirements for eyewear displays. This document is applicable to virtual reality (VR)-type (non-see-through) and augmented reality (AR)-type (see-through) eyewear displays using virtual image optics. The specifications and requirements for prescription lenses are out of the scope of this document.

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)*

Regulation Number	Device Name	Device Class	Product Code
§882.4560	Orthopedic Stereotaxic Instrument	Class 2	OLO
886.5500	Digital Therapy Device For Amblyopia	Class 2	QQU
§890.5800	Virtual Reality Behavioral Therapy Device For Pain Relief	Class 2	QRA
§892.2050	System, Image Processing, Radiological	Class 2	LLZ

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/