Recognized standard
11138-7 First edition 2019-03
FDA recognition 14-610 · ISO · Sterility
Key facts
| Recognition number | 14-610 |
|---|---|
| Designation | 11138-7 First edition 2019-03 |
| Title | Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. It does not consider those processes that rely solely on physical removal of… |
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: