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

Part B: Supplementary Information

Recognition Number 12-255: IEC 60601-2-11 Edition 3.0 2013-01, medical electrical equipment - part 2-11: particular requirements for the basic safety and essential performance of gamma beam therapy equipment. (Radiology)

Date of Standard: 2013. 
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:
Radionuclide Radiation Therapy 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.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.5050 Accelerator, Linear, Medical Class 2 IYE
§892.5050 Accessory - Film Dosimetry System Class 2 MWW
§892.5050 Betatron, Medical Class 2 IYG
§892.5050 Cyclotron, Medical Class 2 IWK
§892.5050 Microtron, Medical Class 2 JAE
§892.5050 Synchrotron, Medical Class 2 IWM
§892.5050 System, Radiation Therapy, Charged-Particle, Medical Class 2 LHN
§892.5050 System,Planning,Radiation Therapy Treatment Class 2 MUJ
§892.5750 Device, Beam Limiting, Teletherapy, Radionuclide Class 2 IWD
§892.5750 System, Radiation Therapy, Radionuclide Class 2 IWB
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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