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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 12-259: IEC 61674 Edition 2.0 2012-11, medical electrical equipment -- dosimeters with ionization chambers and/or semiconductor detectors as used in x-ray diagnostic imaging. (Radiology)

Date of Standard: 1997. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
Dosimeters used in X-ray Diagnostic Imaging
Processes Affected:
510(k), PMA, IDE, HDE
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
§892.5050 Accessory - Film Dosimetry System Class 2 MWW
§892.5650 System, Applicator, Radionuclide, Manual Class 1 IWJ
§892.5700 System, Applicator, Radionuclide, Remote-Controlled Class 2 JAQ
§892.5750 Device, Beam Limiting, Teletherapy, Radionuclide Class 2 IWD
§892.5750 System, Radiation Therapy, Radionuclide Class 2 IWB
§892.5840 System, Simulation, Radiation Therapy Class 2 KPQ
§892.5900 System, Therapeutic, X-Ray Class 2 JAD
§892.5930 Assembly, Tube Housing, X-Ray, Therapeutic Class 2 ITZ
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
* 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