Recognized standard
52303 First edition 2015-07-15
FDA recognition 14-483 · ISO · Sterility
Key facts
| Recognition number | 14-483 |
|---|---|
| Designation | 52303 First edition 2015-07-15 |
| Title | Guide for absorbed-dose mapping in radiation processing facilities |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jun 27, 2016 |
| Scope (excerpt) | ISO/ASTM 52303:2015 provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities. |
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: