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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 003 Date of Entry 07/12/1999 
FR Recognition Number 12-51
IEC  61145 (1992-05)
Calibration and usage of ionization chamber systems for assay of radionuclides
This International Standard covers the techniques for the quantification of the activity of identified radionuclides using any of a variety of ionization chambers currently available
for this purpose. The application of the standard is limited to instruments that incorporate well-type ionization chambers as detectors.

This standard provides a method for obtaining measurements that are accurate to within ±10 % and reproducible to within ±5 % (usually for sources of more than 3,7 x 10 6 Bq (100 pCi)).
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.
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, Issued 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
 John Chen
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.