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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 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/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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