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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 12-259
Standard
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
Scope/Abstract
This International Standard specifies the performance and some related constructional requirements of DIAGNOSTIC DOSIMETERS intended for the measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT or AIR KERMA RATE, in photon radiation fields used in RADIOGRAPHY, including mammography, RADIOSCOPY and COMPUTED TOMOGRAPHY (CT), for X-radiation with generating potentials not greater than 150 kV.

This International Standard is applicable to the performance of DOSIMETERS with VENTED IONIZATION CHAMBERS and/or SEMICONDUCTOR DETECTORS as used in X-ray diagnostic imaging.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§892.5930 Assembly, Tube Housing, X-Ray, Therapeutic Class 2 ITZ
§892.5900 System, Therapeutic, X-Ray Class 2 JAD
§892.5840 System, Simulation, Radiation Therapy Class 2 KPQ
§892.5750 Device, Beam Limiting, Teletherapy, Radionuclide Class 2 IWD
§892.5750 System, Radiation Therapy, Radionuclide Class 2 IWB
§892.5700 System, Applicator, Radionuclide, Remote-Controlled Class 2 JAQ
§892.5650 System, Applicator, Radionuclide, Manual Class 1 IWJ
§892.5050 Accessory - Film Dosimetry System Class 2 MWW
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Laurel Burk
  FDA/OMPT/CDRH/OIR/DRH/DXRS/
  301-796-5933
  laurel.burk@fda.hhs.gov
 Rongping Zeng
  FDA/OMPT/CDRH/OSEL/DIDSR/
  301-796-2546
  Rongping.Zeng@fda.hhs.gov
 Lu Jiang
  OMPT/CDRH/OIR/DRH/DXRS
  240-402-5779
  Lu.Jiang@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
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