FDA-recognized standard · Sterility

ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Yes. FDA recognizes ASTM F1980-21 as recognition 14-575, entered 2023-02-20.

Recognized editions of ASTM F1980

FDA recognitions of ASTM F1980, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
14-575 ASTM F1980-21 2023-02-20 Complete —

Product codes that cite ASTM F1980

No product code cites ASTM F1980: 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.