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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Entry 01/27/2015 
FR Recognition Number 12-285
Standard(Included in ASCA pilot)
IEC 60601-2-1 Edition 3.1 2014-07
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Scope/Abstract
IEC 60601-2-1:2009 applies to the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients. This particular standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the me equipment. This third edition cancels and replaces the second edition published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. This third edition addresses the following issues not covered in previous editions:
- alignment with the new relevant collateral standards;
- new technologies in radiotherapy, including stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT), intensity modulated radiotherapy (IMRT), electronic imaging devices (e.g. EPID) and moving beam radiotherapy (dynamic therapy).
Extent of Recognition
Complete standard
Transition Period
FDA recognition of IEC 60601-2-1 Edition 3.0 2013-01 [Rec# 12-285] will be superseded by recognition of IEC 60601-2-1 Edition 4.0 2020-10 [Rec# 12-338]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 12-285] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 12-285] will not be accepted.
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 Accessory - Film Dosimetry System Class 2 MWW
§892.5050 Betatron, Medical Class 2 IYG
§892.5050 Cyclotron, Medical Class 2 IWK
§892.5050 Dosimeter, Ionizing Radiation, Implanted Class 2 NZT
§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
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

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
 Jin Zhang
  CDRH/OPEQ/OIDRH/DRH/NMRTB
  301-796-5938
  Jin.Zhang@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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