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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 046 Date of Entry 12/23/2016 
FR Recognition Number 12-304
IEC  60731 Edition 3.1 2016-04
Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
IEC 60731:2011 specifies the performance requirements of radiotherapy dosimeters, intended for the measurement of absorbed dose to water or air kerma (and their rates and spatial distributions) in photon, electron, proton or heavy ion radiation fields as used in radiotherapy. The dose monitoring systems incorporated in radiotherapy treatment machines are not covered by this standard, neither are the re-entrant ionization chambers used for brachytherapy source calibration and constancy check devices. IEC 60731:2011 is applicable to the following types of dosimeter:
- a) field-class dosimeters normally used for
1) in vivo skin surface or intracavitary measurements of dose on patients.
2) in vivo skin surface or intracavitary measurements of dose on patients.
b) reference-class dosimeters normally used for the calibration of field-class dosimeters;
c) scanning-class dosimeters normally used for relative dose distribution measurements with a scanning system such as an automatic water phantom.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.5050 Cyclotron, Medical Class 2 IWK
§892.5050 Synchrotron, Medical Class 2 IWM
§892.5050 Accelerator, Linear, Medical Class 2 IYE
§892.5050 Betatron, Medical Class 2 IYG
§892.5050 Microtron, Medical Class 2 JAE
§892.5050 System, Radiation Therapy, Charged-Particle, Medical Class 2 LHN
§892.5050 System, Planning, Radiation Therapy Treatment Class 2 MUJ
§892.5050 Accessory - Film Dosimetry System Class 2 MWW
§892.5750 System, Radiation Therapy, Radionuclide Class 2 IWB
§892.5750 Device, Beam Limiting, Teletherapy, Radionuclide Class 2 IWD
§892.5900 Generator, Orthovoltage, Therapeutic X-Ray Class 2 IYC
§892.5900 Generator, Low Voltage, Therapeutic X-Ray Class 2 IYD
§892.5900 Generator, Dermatological (Grenz Ray), Therapeutic X-Ray Class 2 IYH
§892.5900 Collimator, Orthovoltage, Therapeutic X-Ray Class 2 IYI
§892.5900 Collimator, Low Voltage, Therapeutic X-Ray Class 2 IYJ
§892.5900 Collimator, High Voltage, Therapeutic X-Ray Class 2 IYK
§892.5900 Collimator, Dermatological, Therapeutic X-Ray Class 2 IYL
§892.5900 System, Therapeutic, X-Ray Class 2 JAD
§892.5900 Generator, High Voltage, X-Ray, Therapeutic Class 2 KPZ
§892.5900 Device, Beam Limiting, X-Ray, Therapeutic Class 2 KQA
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 Contact
 William Jung
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.