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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 063 Date of Entry 12/23/2024 
FR Recognition Number 1-192
Standard
ISO  23371 First edition 2022-05
Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices
Scope/Abstract
This document specifies essential performance and safety requirements for cuff pressure indicators used to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes.

This document is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range.

The requirements specified in this document apply to stand-alone cuff pressure indicators and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.
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
§868.5750 Cuff, Tracheal Tube, Inflatable Class 2 BSK
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/OMPT/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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