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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 046 Date of Entry 12/23/2016 
FR Recognition Number 12-303
IEC  61303 Edition 1.0 1994-09
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)]
Covers radionuclide calibrators of the well type, with a gas-filled ionization chamber as used in the practice of nuclear medicine. The object of this Standard is to identify the most important characteristics of radionuclide calibrators and lay down associated test methods to enable manufacturers to declare the characteristics of their devices in a standardized way and facilitate comparisons between devices.

Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1360 Radionuclide dose calibrator.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry - Guidance for the Submission of Premarket Notification for Radionuclide Dose Calibrators. Document Issued on November 20, 1998

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
 William Jung
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.