Recognized standard
11137-3 Second edition 2017-06 11137-3:2017/(R)2023
FDA recognition 14-510 · ISO · Sterility
Key facts
| Recognition number | 14-510 |
|---|---|
| Designation | 11137-3 Second edition 2017-06 11137-3:2017/(R)2023 |
| Title | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jun 7, 2018 |
| Scope (excerpt) | ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process. |
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: