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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR 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
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
§892.5050 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 System, Radiation Therapy, Radionuclide Class 2 IWB
§892.5750 Device, Beam Limiting, Teletherapy, Radionuclide Class 2 IWD
§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 FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Laurel Burk
 Rongping Zeng
 Lu Jiang
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.