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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 024 FR Publication Date: 06/10/2010 

Part B: Supplementary Information

Recognition Number 6-232: ISO 80601-2-56 First Edition 2009-10-01, medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. (General Plastic Surgery/General Hospital)

Date of Standard: 2009. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
(3)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
Devices Affected:
Electronic Clinical Thermometers
Processes Affected:
510(k), IDE, PreIDE, HDE, GMP, Design Controls
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.2910 Thermometer, Electronic, Clinical Class 2 FLL
Relevant Guidance:
Guidance on the Content of Premarket Notification [510(k)] Submissions for Clinical Electronic Thermometers
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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