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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 6-230: AAMI / ANSI / IEC 60601-2-19:2009, medical electrical equipment - part 2-19: particular requirements for the basic safety and essential performance of infant incubators. (General Plastic Surgery/General Hospital)

Date of Standard: 2009. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
 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FDA recognition of IEC 60601-2-19 1996-10:Amendment 1 is hereby superseded by recognition of ANSI/AAMI/IEC 60601-2-19:2009 Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential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, to 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:
 Nancy Pressly
  FDA/CDRH/OSB
  10903 New Hampshire Avenue Building 66, Room 3204
  Silver Spring MD 20993
  301/796-5437
  email: nancy.pressly@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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