Recognized standard
TIR12:2020/(R)2023
FDA recognition 14-602 · AAMI · Sterility
Key facts
| Recognition number | 14-602 |
|---|---|
| Designation | TIR12:2020/(R)2023 |
| Title | Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Sterility |
| Date of entry | May 29, 2024 |
| Scope (excerpt) | This technical information report (TIR) provides guidance to medical device manufacturers, who are required to provide instructions that detail the processing steps from pre-treatment at the point of use through the terminal process and storage to accompany reusable and single-use medical devices… |
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: