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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 6-320: IEC 60601-2-20 Edition 2.0 2009-02, medical electrical equipment - part 2-20: particular requirements for the basic safety and essential performance of infant transport incubators [including: technical corrigendum 1 (2012) and technical corrigendum 2 (2013)]. (General Plastic Surgery/General Hospital)

Date of Standard: 2009. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Transport Incubator
Processes Affected:
510(k), PMA, IDE, PreIDE, HDE, GMP, Design Controls
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
§880.5410 Incubator, Neonatal Transport Class 2 FPL
Relevant Guidance:
Guidance for Industry and FDA Reviewera/Staff Neonatal and Neonatal Transport Incubators - Premarket Notifications Documents issued on: September 18, 1998
FDA Technical Contact:
 William Burdick
  10903 New Hampshire Avenue Building 66, Room 2522
  Silver Spring MD 20993
  email: william.burdick@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