Recognized standard
11139 First edition 2018-08
FDA recognition 14-543 · ISO · Sterility
Key facts
| Recognition number | 14-543 |
|---|---|
| Designation | 11139 First edition 2018-08 |
| Title | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | This document defines terms in the field of the sterilization of health care products including related equipment and processes. |
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: