Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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062
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Date of Entry 05/29/2024
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FR Recognition Number
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12-360
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Standard | |
IEC 63145-10 Edition 1.0 2023-09 Eyewear display - Part 10: Specifications |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§882.4560 |
Orthopedic Stereotaxic Instrument
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Class 2
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OLO
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886.5500 |
Digital Therapy Device For Amblyopia
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Class 2
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QQU
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§890.5800 |
Virtual Reality Behavioral Therapy Device For Pain Relief
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Class 2
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QRA
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§892.2050 |
System, Image Processing, Radiological
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Class 2
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LLZ
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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. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |