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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 034 Date of Entry 01/30/2014 
FR Recognition Number 12-59
Standard
IEC  61168:1993
Radiotherapy simulators - Functional performance characteristics
Scope/Abstract
Specifies type tests to be performed by the manufacturer at the design and construction stages of a radiotherapy simulator but does not specify site tests to be performed after installation at the user's site. The accompanying technical report IEC 61170, however, does suggest that many of the test procedures are appropriate for site tests.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.5840 Radiation therapy simulation system.
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
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/NMRTB/
  301-796-6548
  nancy.wersto@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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