Recognized standard
TIR28:2016/(R)2020
FDA recognition 14-603 · AAMI · Sterility
Key facts
| Recognition number | 14-603 |
|---|---|
| Designation | TIR28:2016/(R)2020 |
| Title | Product adoption and process equivalence for ethylene oxide sterilization |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Sterility |
| Date of entry | May 29, 2024 |
| Scope (excerpt) | This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the… |
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: