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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Entry 03/16/2012 
FR Recognition Number 1-72
Standard
ISO 10651-5 First edition 2006-02-01
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
U.S. Identical Adoption
ANSI AAMI ISO 10651-5:2006
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
Scope/Abstract
ISO 10651-5:2006 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators intended for use with humans by first responders. This equipment is intended for emergency field use and is intended to be continuously operator attended in normal use.
ISO 10651-5:2006 also specifies the requirements for resuscitator sets.
ISO 10651-5:2006 is not applicable to electrically-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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5925 Ventilator, Emergency, Powered (Resuscitator) Class 2 BTL
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. AAMI COVID-19 Emergency Guidance for the design of ventilator, resuscitator, CPAP/BiPAP systems is available at https://www.aami.org/news-resources/covid-19-updates/covid_cr. Check back frequently for the latest version as these are living documents that evolve with experience.

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
 James J. Lee
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-8463
  James.J.Lee@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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