Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

046

Date of Entry 12/23/2016 

FR Recognition Number

12-304

Standard

IEC  60731 Edition 3.1 2016-04
Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

Scope/Abstract

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

  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/

  301-796-6228

  william.jung@fda.hhs.gov

Standards Development Organization

IEC International Electrotechnical Commission http://www.iec.ch/

FDA Specialty Task Group (STG)

Radiology

*These are provided as examples and others may be applicable.