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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 1-73: ISO 10651-4 First edition 2002-03-01, lung ventilators - part 4: particular requirements for operator powered resuscitators. (Anesthesiology)

Date of Standard: 2002. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Manually-powered ventilatory resuscitators intended for emergency use both outside and inside hospitals
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
§868.5915 Ventilator, Emergency, Manual (Resuscitator) Class 2 BTM
Relevant Guidance:
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Guidance for Industry and Food and Drug Administration Staff, March 2015

Draft Emergency Resuscitator Guidance, April 1993

Draft Reviewer Guidance for Ventilators, July 1995
FDA Technical Contact:
 James J. Lee
  10903 New Hampshire Avenue WO66 RM2528
  Silver Spring MD 20993
  email: James.J.Lee@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036