Recognized standard
11140-1 Third edition 2014-11-01 11140-1:2014
FDA recognition 14-460 · ISO · Sterility
Key facts
| Recognition number | 14-460 |
|---|---|
| Designation | 11140-1 Third edition 2014-11-01 11140-1:2014 |
| Title | Sterilization of health care products - Chemical indicators - Part 1: General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Sep 9, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a… |
At a glance
- 1–9 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: