Recognized standard
11135 Second edition 2014-07-15 11135:2014/A1:2018
FDA recognition 14-529 · ISO · Sterility
Key facts
| Recognition number | 14-529 |
|---|---|
| Designation | 11135 Second edition 2014-07-15 11135:2014/A1:2018 |
| Title | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] Sterilization of health-care products - Ethylene oxide - Requirements for the development… |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications. |
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: