Recognized standard
TIR11137-4:2022 TS 11137-4 First edition 2020-06
FDA recognition 14-582 · ISO · Sterility
Key facts
| Recognition number | 14-582 |
|---|---|
| Designation | TIR11137-4:2022 TS 11137-4 First edition 2020-06 |
| Title | Sterilization of health care products - Radiation - Part 4: Guidance on process control |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation. |
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: