Recognized standard
N42.13-2004
FDA recognition 12-141 · IEEE · Radiology
Key facts
| Recognition number | 12-141 |
|---|---|
| Designation | N42.13-2004 |
| Title | Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides |
| Standards developer | Institute of Electrical and Electronic Engineers |
| Specialty area | Radiology |
| Date of entry | Mar 31, 2006 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: