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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 065 Date of Entry 12/22/2025 
FR Recognition Number 1-200
Standard
ISO  7376-2 First edition 2025-09
Anaesthetic and respiratory equipment - Part 2: Video laryngoscopes
Scope/Abstract
This document specifies requirements for electrically powered video laryngoscopes that comprise a handle, a rigid blade, a light source, a camera and an image display that provides a clear view of the larynx to assist tracheal intubation. This document specifies requirements for accessories that are essential to the function of the video laryngoscope.

This document is not applicable to the following:

- laryngoscopes without a camera or image display (see ISO 7376);

- endoscopes (see ISO 8600-1);

- laryngoscopes designed for surgery;

- image quality requirement for third party display screens, for example a phone or computer monitor, and which are not supplied by the video laryngoscope manufacturer as part of the video laryngoscope system.
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
§868.5530 Laryngoscope, Non-Rigid Class 1 CAL
§868.5540 Laryngoscope, Rigid Class 1 CCW
§868.5540 Laryngoscope Kit Class 1 OGH
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 Contact
 Annie Abraham
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  240-402-5219
  Annie.Abraham@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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