Recognized standard
51649 Third edition 2015-03-15
FDA recognition 14-464 · ISO · Sterility
Key facts
| Recognition number | 14-464 |
|---|---|
| Designation | 51649 Third edition 2015-03-15 |
| Title | Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Aug 14, 2015 |
| Scope (excerpt) | ISO/ASTM 51649:2015 outlines dosimetric procedures to be followed in installation qualification (IQ), operational qualification (OQ) and performance qualifications (PQ), and routine processing at electron beam facilities. The electron beam energy range covered in this practice is between 300 keV and… |
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: