FDA-recognized standard · General I (QS/RM)
ISO 80369-6: Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
Yes. FDA recognizes ISO 80369-6 Second edition 2025-05 as recognition 5-146, entered 2025-12-22. FDA also lists ISO 80369-6 First Edition 2016-03-15 (recognition 5-108, transition period ending 2028-12-17).
Recognized editions of ISO 80369-6
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 5-146 | ISO 80369-6 Second edition 2025-05 | 2025-12-22 | Complete | — |
| 5-108 | ISO 80369-6 First Edition 2016-03-15 | 2016-06-27 | Complete | 2028-12-17 |
Regulations
FDA lists these classification regulations against ISO 80369-6: 21 CFR 868.5120, 21 CFR 868.5140, 21 CFR 868.5150, 21 CFR 880.5440, 21 CFR 880.5860, 21 CFR 882.1620, 21 CFR 882.4060, 21 CFR 882.4100, 21 CFR 882.5550, 21 CFR 882.5560.
Product codes that cite ISO 80369-6
12 FDA product codes cite ISO 80369-6, including BSO, BSP, CAZ, FMF, FPA.
- BSO
- BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
- CAZ
- FMF Syringe, Piston
- FPA Set, Administration, Intravascular
- GWM Device, Monitoring, Intracranial Pressure
- HCA
- HCD
- JXG Shunt, Central Nervous System And Components
- NHC
- PCB
- PWH
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.