| IEEE N42.13-2004 Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides |
| Recognition Date | 2006-03-31 |
| Recognition List | 014 |
| Recognition Number | 12-141 |
| Extent | Complete standard |
| Standards Orgs | IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/ |
| STG | Radiology |
| FDA Tech | John Chen FDA/OMPT/CDRH/OIR/DRH/NMRT/ 301-796-6540 john.chen@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.1360 | Calibrator, Dose, Radionuclide | Class 2 | KPT |
| Guidance for Industry: Guidance for the Submission of Premarket Notification for Radionuclide Dose Calibrators, Issued November 20, 1998 |