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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 12-267
Standard
IEC  61217 Edition 2.0 2011-12
Radiotherapy equipment - Coordinates, movements, and scales
Scope/Abstract
This International Standard applies to equipment and data related to the process of TELERADIOTHERAPY, including PATIENT image data used in relation with RADIOTHERAPY TREATMENT PLANNING SYSTEMS, RADIOTHERAPY SIMULATORS, isocentric GAMMA BEAM THERAPY EQUIPMENT, isocentric medical ELECTRON ACCELERATORS, and non-isocentric equipment when relevant.

The object of this standard is to define a consistent set of coordinate systems for use throughout the process of TELERADIOTHERAPY, to define the marking of scales (where provided), to define the movements of ME EQUIPMENT used in this process, and to facilitate computer control when used.
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 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
§892.5050 Dosimeter, Ionizing Radiation, Implanted Class 2 NZT
§892.5300 System, Radiation Therapy, Neutron, Medical Class 2 IWL
§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
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
 Nancy Wersto
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/NMRTB/
  301-796-6548
  nancy.wersto@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.
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