Recognized standard
51818 Fourth edition 2020-06
FDA recognition 14-552 · ISO · Sterility
Key facts
| Recognition number | 14-552 |
|---|---|
| Designation | 51818 Fourth edition 2020-06 |
| Title | Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | This practice covers dosimetric procedures to be followed in installation qualification, operational qualification and performance qualification (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses… |
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: