| IEC 60731 Edition 3.1 2016-04 Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| Recognition Date | 2016-12-23 |
| Recognition List | 046 |
| Recognition Number | 12-304 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Radiology |
| FDA Tech | William Jung FDA/OMPT/CDRH/OIR/DRH/NMRT/ 301-796-6228 william.jung@fda.hhs.gov |
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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.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.5900 | Collimator, Dermatological, Therapeutic X-Ray | Class 2 | IYL |
| §892.5900 | Collimator, High Voltage, Therapeutic X-Ray | Class 2 | IYK |
| §892.5900 | Collimator, Low Voltage, Therapeutic X-Ray | Class 2 | IYJ |
| §892.5900 | Collimator, Orthovoltage, Therapeutic X-Ray | Class 2 | IYI |
| §892.5900 | Device, Beam Limiting, X-Ray, Therapeutic | Class 2 | KQA |
| §892.5900 | Generator, Dermatological (Grenz Ray), Therapeutic X-Ray | Class 2 | IYH |
| §892.5900 | Generator, High Voltage, X-Ray, Therapeutic | Class 2 | KPZ |
| §892.5900 | Generator, Low Voltage, Therapeutic X-Ray | Class 2 | IYD |
| §892.5900 | Generator, Orthovoltage, Therapeutic X-Ray | Class 2 | IYC |
| §892.5900 | System, Therapeutic, X-Ray | Class 2 | JAD |
| §892.5750 | Device, Beam Limiting, Teletherapy, Radionuclide | Class 2 | IWD |
| §892.5750 | System, Radiation Therapy, Radionuclide | Class 2 | IWB |
| §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, Planning, Radiation Therapy Treatment | Class 2 | MUJ |
| §892.5050 | System, Radiation Therapy, Charged-Particle, Medical | Class 2 | LHN |
| There is no relevant guidance developed at this time. |