Recognized standard
63465 Edition 1.0 2026-01
FDA recognition 12-386 · IEC · Radiology
Key facts
| Recognition number | 12-386 |
|---|---|
| Designation | 63465 Edition 1.0 2026-01 |
| Title | Calibration and quality control in the use of radionuclide calibrators |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 25, 2026 |
| Scope (excerpt) | This document specifies the techniques for calibration and usage of pressurised, well-type ionisation chambers for activity measurements of radioactive sources. Such instruments are used to determine the activity, expressed in becquerel (Bq), of photon and some medium to high-energy beta-emitters… |
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: