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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 064 Date of Entry 05/26/2025 
FR Recognition Number 10-138
Standard
ISO  16971-1 First edition 2024-11
Ophthalmic instruments - Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye
Scope/Abstract
This document is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye.

This document specifies characteristics and minimum requirements for OCT instruments and systems. It specifies type tests and procedures to verify that a system or instrument qualifies as an OCT instrument or system in accordance with this document.

NOTE In this document the term OCT refers to ophthalmic applications.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Any reference to ISO 15004-2 in the 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.

This standard is recognized in part because:

Reference to ISO 15004-2 for light hazard protection is in conflict with another FDA-recognized standard (See ANSI Z80.36-2021 listed below). FDA has replaced ISO 15004-2 with ANSI Z80.36 as the recognized standard for light hazard protection in ophthalmic instruments.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.1570 Tomography, Optical Coherence Class 2 OBO
Relevant FDA Guidance and/or Supportive Publications*
ANSI Z80.36-2021 Ophthalmics - Light Hazard Protection for Ophthalmic Instruments.

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 Contact
 Shulei Zhao
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  240-402-5358
  Shulei.Zhao@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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