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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 12-338
Standard(Included in ASCA pilot)
IEC 60601-2-1 Edition 4.0 2020-10
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
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for TREATMENT of PATIENTS.

This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the manufacture and some installation aspects of ELECTRON ACCELERATORS and their included equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT delivery
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.
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FDA recognition of IEC 60601-2-1 Edition 3.0 2013-01 [Rec# 12-285] will be superseded by recognition of IEC 60601-2-1 Edition 4.0 2020-10 [Rec# 12-338].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.
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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