Recognized standard
51261 Second edition 2013-04-15
FDA recognition 14-381 · ISO · Sterility
Key facts
| Recognition number | 14-381 |
|---|---|
| Designation | 51261 Second edition 2013-04-15 |
| Title | Practice for calibration of routine dosimetry systems for radiation processing |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Aug 6, 2013 |
| Scope (excerpt) | ISO/ASTM 51261:2013 specifies the requirements for calibrating routine dosimetry systems for use in radiation processing, including establishing measurement traceability and estimating uncertainty in the measured dose using the calibrated dosimetry system. NOTE 1 — Regulations or other directives… |
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: