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FDA-recognized standard · General Plastic Surgery/General Hospital

ISO 11608-4: Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics

Yes. FDA recognizes ISO 11608-4:2022 as recognition 6-475, entered 2022-05-30.

Recognized editions of ISO 11608-4

FDA recognitions of ISO 11608-4, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
6-475 ISO 11608-4:2022 2022-05-30 Complete —

Regulations

FDA lists these classification regulations against ISO 11608-4: 21 CFR 880.5860, 21 CFR 880.6920.

Product codes that cite ISO 11608-4

5 FDA product codes cite ISO 11608-4, including FMF, KZH, MEG, NKN, NSC.

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.