Recognized standard
/TIR104:2022
FDA recognition 14-587 · AAMI · Sterility
Key facts
| Recognition number | 14-587 |
|---|---|
| Designation | /TIR104:2022 |
| Title | Guidance on transferring health care products between radiation sterilization sources |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Sterility |
| Date of entry | May 29, 2023 |
| Scope (excerpt) | The focus of TIR104 is to provide guidance in managing the process for transferring a health care product either from one radiation sterilization modality to another or from one irradiator to another using the same radiation modality. The specific radiation modalities addressed are gamma, electron… |
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: