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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 026 Date of Entry 03/14/2011 
FR Recognition Number 12-217
IEC  62083 Edition 2.0 2009-09
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
This International Standard applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems(RTPS)

- for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice;

- that imports data either through input by the OPERATOR or directly from other devices;

- that outputs data either in printed form for review or directly to other devices;

- and which is intended to be

- for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training;

- maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and

- used within the environmental and electrical supply conditions SPECIFIED in the technical description.
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
§892.5750 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
 Nancy Wersto
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.