Recognized standard
51608 Second edition 2015-03-15
FDA recognition 14-463 · ISO · Sterility
Key facts
| Recognition number | 14-463 |
|---|---|
| Designation | 51608 Second edition 2015-03-15 |
| Title | Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Aug 14, 2015 |
| Scope (excerpt) | ISO/ASTM 51608:2015 outlines the dosimetric procedures to be followed during installation qualification, operational qualification, performance qualification and routine processing at an X-ray (bremsstrahlung) irradiator. Other procedures related to operational qualification, performance… |
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: