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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 6-319: IEC 60601-2-19 Edition 2.0 2009-02, medical electrical equipment - part 2-19: particular requirements for the basic safety and essential peformance of infant incubators [including: technical corrigendum 1 (2012)]. (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
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Include all infant incubators except transport incubators
Processes Affected:
510(k), PMA, IDE, PreIDE, HDE, GMP. Design Controls
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard

Transition:
FDA recognition of IEC 60601-2-19 1996-10: Amendment 1 is hereby superseded by recognition of ANSI/AAMI/IEC 60601-2-19:2009 Medical Electrical Equipment - Prt 2-19: Particular requirements for the basic safety and essential performance of infant incubators. FDA will accept declarations of conformity, in support of premarket submissions, IEC 60601-2-19 1996-10: Amendment 1 until December 31, 2013. After this transitional period, declarations of conformity to IEC 60601-2-1996-10: Amendment 1 will not be accepted.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.5400 Incubator, Neonatal Class 2 FMZ
Relevant Guidance:
Guidance for Industry and FDA Reviewers/Staff Neonatal and Neonatal Transport Incubators - Premarket Notifications Document issued on: September 18, 1998
FDA Technical Contact:
 William Burdick
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2522
  Silver Spring MD 20993
  301/796-6286
  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
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