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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 028 Date of Entry 03/16/2012 
FR Recognition Number 1-73
Standard
ISO  10651-4 First edition 2002-03-01
Lung ventilators - Part 4: Particular requirements for operator powered resuscitators
Scope/Abstract
ISO 10651-4:2002 specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent.
ISO 10651-4:2002 is not applicable to electrically- and gas-powered resuscitators.
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FDA recognition of ISO 10651-4 First edition 2002-03 [Rec# 1-73] will be superseded by recognition of ISO 10651-4 Second edition 2023-03 [Rec# 1-162].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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