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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 12-211: IEC 60601-2-29 Edition 3.0 2008-06, medical electrical equipment - part 2-29: particular requirements for the basic safety and essential performance of radiotherapy simulators. (Radiology)

Date of Standard: 2008. 
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 IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Radiation Therapy Simulation Systems
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard and any annexes with specific national alterations for areas not covered by 21 CFR Subchapter J (1000, et. al.).
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.5840 System, Simulation, Radiation Therapy Class 2 KPQ
FDA Technical Contact:
 John Chen
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room G302
  Silver Spring MD 20993
  301/796-6540
  email: john.chen@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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