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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 028 Date of Entry 03/16/2012 
FR Recognition Number 12-241
IEC  62274 First Edition 2005-05
Medical electrical equipment - Safety of radiotherapy record and verify systems
This International Standard applies to the design and manufacture and some installation aspects of a RECORD AND VERIFY SYSTEM (RVS) for use in RADIOTHERAPY in human medical practice that

a) provides, defines, or displays treatment machine set up data; imports data either through input by the OPERATOR or directly from other devices,

b) may control the ability of that equipment to operate;

c) records data of all TREATMENT sessions; and d) is intended to be:

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

2) maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE; and

3) used within the environmental and electrical supply conditions specified in the technical description.

This standard does not address dynamic beam deliveries. NOTE This may be addressed in a future version of this standard.

It does, however, address certain specific aspects of the connection of the RVS to a network or to other radiotherapy equipment, and the communication protocol to be 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 Accelerator, Linear, Medical Class 2 IYE
§892.5050 System, Radiation Therapy, Charged-Particle, Medical Class 2 LHN
§892.5750 System, Radiation Therapy, Radionuclide Class 2 IWB
§892.5900 System, Therapeutic, X-Ray Class 2 JAD
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.