FDA-recognized standard · Software/Informatics

AAMI TIR57: Principles for medical device security - Risk management.

Yes. FDA recognizes AAMI TIR57:2016 as recognition 13-83, entered 2016-06-27.

Recognized editions of AAMI TIR57

FDA recognitions of AAMI TIR57, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
13-83 AAMI TIR57:2016 2016-06-27 Complete —

Product codes that cite AAMI TIR57

No product code cites AAMI TIR57: it is a horizontal standard, applied across device types rather than tied to particular codes.

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.