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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 1-149
Standard
ISO 7376 Third edition 2020-08 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
Scope/Abstract
This document, which is device-specific, specifies requirements for laryngoscopes with non-flexible blades, with internal battery-operated power sources, used for illuminating the larynx during intubation. It also specifies critical dimensions for those handles and laryngoscope blades with interchangeable hook-on fittings.

It is not applicable to the following:
- flexible laryngoscopes;
- laryngoscopes designed for surgery;
- laryngoscopes powered from mains electricity supply;
- laryngoscopes connected by light-transmitting cables to external light sources;
- video laryngoscopes designed to work with an external, integral or attached video 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.
Transition Period
FDA recognition of ISO 7376 Second edition 2009-08-15 [Rec# 1-123] will be superseded by recognition of ISO 7376 Third edition 2020-08 [Rec# 1-149]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-123] until December 19, 2021. After this transition period, declarations of conformity to [Rec# 1-123] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5540 Laryngoscope Kit Class 1 OGH
§868.5540 Laryngoscope, Rigid Class 1 CCW
FDA Technical Contact
 William C. Maloney
  FDA/OC/CDRH/OPEQ/ORP/DRPIII/
  301-796-6272
  William.Maloney@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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