Recognized standard
11137-2 Third edition 2013-06 [Including AMD1:2022]
FDA recognition 14-580 · ISO · Sterility
Key facts
| Recognition number | 14-580 |
|---|---|
| Designation | 11137-2 Third edition 2013-06 [Including AMD1:2022] |
| Title | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. ISO 11137-2:2013 also specifies methods… |
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: