FDA-recognized standard · General Plastic Surgery/General Hospital
ISO 11608-7: Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
Yes. FDA recognizes ISO 11608-7 First edition 2016-08-01 as recognition 6-382, entered 2016-09-21.
Recognized editions of ISO 11608-7
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 6-382 | ISO 11608-7 First edition 2016-08-01 | 2016-09-21 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 11608-7: 21 CFR 880.5860, 21 CFR 880.6920.
Product codes that cite ISO 11608-7
5 FDA product codes cite ISO 11608-7, 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.