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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 1-123
Standard
ISO 7376 Second edition 2009-08-15 Anaesthetic and respiratory equipment-Laryngoscopes for tracheal intubation
Scope/Abstract
ISO 7376:2009 gives general requirements for laryngoscopes used for intubation, and specifies critical dimensions for the handle and lamp of hook-on type laryngoscopes. It also addresses the interchangeability of blades and handles.
It is applicable only to instruments with an internal battery-operated power source for illuminating the larynx, since electrical safety requirements can be more stringent for instruments connected to mains or external power packs.
It is not applicable to surgical instruments known by the same generic name, nor is it applicable to flexible laryngoscopes or laryngoscopes designed for surgery, laryngoscopes powered from mains electricity supply, laryngoscopes connected by light-transmitting cables to external light sources, or video laryngoscopes designed to work with an external 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FDA recognition of ISO 7376 Second edition 2009-08-15 [Rec# 1-123] will be superseded by recognition of ISO 7376 Third edition 2020-08 [Rec# 1-149].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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