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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 1-98: ISO 80601-2-12 First edition 2011-04-15, medical electrical equipment - part 2-12: particular requirements for the safety of lung ventilators - critical care ventilators [including: technical corrigendum 1 (2011)]. (Anesthesias)

Date of Standard: 2011. 
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:
Lung ventilators incorporating electrical devices designed for medical use excluding lung ventilators specified for use with inhalation anesthetic agents.
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
§868.5895 Ventilator, Continuous, Facility Use Class 2 CBK
§868.5895 Ventilator, Continuous, Minimal Ventilatory Support,Facility Use Class 2 MNT
§868.5895 Ventilator, Continuous, Non-Life-Supporting Class 2 MNS
Relevant Guidance:
Draft Reviewer Guidance for Ventilators, July 1995

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Guidance for Industry and Food and Drug Administration Staff, March 2015

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005

Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design: June 22, 2011
FDA Technical Contact:
 Bahram Parvinian
  10903 New Hampshire Avenue Building 66, Room 2534
  Silver Spring MD 20993
  email: bahram.parvinian@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