Recognized standard
51702 Third edition 2013-04-15
FDA recognition 14-383 · ISO · Sterility
Key facts
| Recognition number | 14-383 |
|---|---|
| Designation | 51702 Third edition 2013-04-15 |
| Title | Practice for dosimetry in a gamma facility for radiation processing |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Aug 6, 2013 |
| Scope (excerpt) | ISO/ASTM 51702:2013 outlines the installation qualification program for an irradiator and the dosimetric procedures to be followed during operational qualification, performance qualification, and routine processing in facilities that process products with ionizing radiation from radionuclide gamma… |
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: