FDA-recognized standard · Sterility

AAMI TIR17: Compatibility of materials subjected to sterilization

Yes. FDA recognizes AAMI TIR17:2024 as recognition 14-609, entered 2024-12-23. FDA also lists AAMI TIR17:2017/(R)2020 (recognition 14-588, transition period ending 2027-12-19).

Recognized editions of AAMI TIR17

FDA recognitions of AAMI TIR17, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
14-609 AAMI TIR17:2024 2024-12-23 Complete —
14-588 AAMI TIR17:2017/(R)2020 2023-05-29 Complete 2027-12-19

Regulations

FDA lists these classification regulations against AAMI TIR17: 21 CFR 880.6100, 21 CFR 880.6860, 21 CFR 880.6870, 21 CFR 880.6880.

Product codes that cite AAMI TIR17

6 FDA product codes cite AAMI TIR17, including FLE, FLF, FLI, KMH, MLR.

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.