Recognized standard
TIR106:2024
FDA recognition 14-608 · AAMI · Sterility
Key facts
| Recognition number | 14-608 |
|---|---|
| Designation | TIR106:2024 |
| Title | Microbiological methods - Understanding and use of product bioburden data |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Sterility |
| Date of entry | Dec 23, 2024 |
| Scope (excerpt) | This document provides guidance regarding the understanding and use of product bioburden data including: what bioburden data represent; how to use bioburden data to support a sterilization process; the analysis and characterization of bioburden; establishment and the use of alert and action levels… |
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: