FDA-recognized standard · General Plastic Surgery/General Hospital

ISO 11608-1: Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems

Yes. FDA recognizes ISO 11608-1:2022 as recognition 6-478, entered 2022-05-30.

Recognized editions of ISO 11608-1

FDA recognitions of ISO 11608-1, newest first (FDA database snapshot of 2026-09-01)
Recognition	Edition	Entered	Extent	Transition ends
6-478	ISO 11608-1:2022	2022-05-30	Complete	—

FDA lists these classification regulations against ISO 11608-1: 21 CFR 880.5860, 21 CFR 880.6920.

5 FDA product codes cite ISO 11608-1, 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.