Recognized standard
11138-1 Third edition 2017-03 11138-1:2017
FDA recognition 14-502 · ISO · Sterility
Key facts
| Recognition number | 14-502 |
|---|---|
| Designation | 11138-1 Third edition 2017-03 11138-1:2017 |
| Title | Sterilization of health care products - Biological indicators - Part 1: General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. ISO… |
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: