Recognized standard
52701 First edition 2013-11-15 (R2020)
FDA recognition 14-437 · ISO · Sterility
Key facts
| Recognition number | 14-437 |
|---|---|
| Designation | 52701 First edition 2013-11-15 (R2020) |
| Title | Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jul 9, 2014 |
| Scope (excerpt) | ISO/ASTM 52701:2013 provides guidance on determining the performance characteristics of dosimeters and dosimetry systems used in radiation processing. ISO/ASTM 52701:2013 describes the influence quantities that might affect the performance of dosimeters and dosimetry systems and that should be… |
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: