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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 12-301
Standard(Included in ASCA pilot)
IEC 60601-2-8 Edition 2.1 b:2015
Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
Scope/Abstract
IEC 60601-2-8:2010+A1:2015 establishes particular basic safety and essential performance requirements for therapeutic X-ray equipment with nominal X-ray tube voltages in the range 10 kV to 1 MV when connected to alternating current supply mains. It includes the requirements for accuracy and reproducibility of performance to the extent that these are related to radiation quality and the quantity of ionizing radiation produced and thus must be considered as aspects of safety. This second edition cancels and replaces the first edition of IEC 60601-2-8. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§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*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
FDA Technical Contact
 John Chen
  FDA/OMPT/CDRH/OIR/DRH/NMRT/
  301-796-6540
  john.chen@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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