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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 061 Date of Entry 12/18/2023 
FR Recognition Number 1-162
Standard
ISO  10651-4 Second edition 2023-03
Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
Scope/Abstract
This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range.

Example user-powered resuscitators include:

- self-inflating bag resuscitators intended to be squeezed by the user's hand and refilled by elastic recoil; and

NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations.

- flow-inflating bag resuscitators intended to be squeezed by the user's hand and refilled by a flow from a medical gas source.

This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator.
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FDA recognition of ISO 10651-4 First edition 2002-03 [Rec# 1-73] will be superseded by recognition of ISO 10651-4 Second edition 2023-03 [Rec# 1-162]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-73] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 1-73] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5915 Ventilator, Emergency, Manual (Resuscitator) Class 2 BTM
Relevant FDA Guidance and/or Supportive Publications*
1. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 2015.

2. Guidance for Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff, issued June 2023.

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
 Ethan Nyberg
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  240-402-5973
  Ethan.Nyberg@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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