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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 014 Date of Entry 03/31/2006 
FR Recognition Number 12-141
IEEE  N42.13-2004
Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides
2.1 This standard covers the technique for the quantification of the activity of identified radionuclides using any of a variety of ionization chambers currently available for this purpose. Application of the standard is limited to instruments that incorporate well-type ionization chambers as detectors.

2.2 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 100 mCi (3.7* 10^6 Bq)]. The standard is also intended to assure continuing performance of the apparatus within these specifications. For purposes of this standard, accuracy and reproducibility are described in 4.6.
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 Calibrator, Dose, Radionuclide Class 2 KPT
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
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.