FDA-recognized standard · General Plastic Surgery/General Hospital
AAMI TIR38: Medical device safety assurance case guidance
Yes. FDA recognizes AAMI TIR38:2019 as recognition 6-422, entered 2019-07-15.
Recognized editions of AAMI TIR38
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 6-422 | AAMI TIR38:2019 | 2019-07-15 | Complete | — |
Regulations
FDA lists these classification regulations against AAMI TIR38: 21 CFR 880.5725, 21 CFR 880.5730.
Product codes that cite AAMI TIR38
9 FDA product codes cite AAMI TIR38, including FRN, LKK, LZG, LZH, MEA.
- FRN Pump, Infusion
- LKK
- LZG Pump, Infusion, Insulin
- LZH
- MEA
- MEB
- MRZ
- OPP
- PHC
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.