Recognized standard
52628 Second edition 2020-04
FDA recognition 14-542 · ISO · Sterility
Key facts
| Recognition number | 14-542 |
|---|---|
| Designation | 52628 Second edition 2020-04 |
| Title | Standard practice for dosimetry in radiation processing |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | 1.1 This practice describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E61 series of dosimetry standards. In addition, it provides guidance on the selection of dosimetry systems and directs the user to other standards that provide specific… |
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: