Recognized standard
11138-8 First edition 2021-07
FDA recognition 14-571 · ISO · Sterility
Key facts
| Recognition number | 14-571 |
|---|---|
| Designation | 11138-8 First edition 2021-07 |
| Title | Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization… |
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: