FDA-recognized standard · General I (QS/RM)
ISO 80369-3: Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
Yes. FDA recognizes ISO 80369-3 First Edition 2016-07-01 as recognition 5-123, entered 2019-07-15.
Recognized editions of ISO 80369-3
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 5-123 | ISO 80369-3 First Edition 2016-07-01 | 2019-07-15 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 80369-3: 21 CFR 876.5980.
Product codes that cite ISO 80369-3
10 FDA product codes cite ISO 80369-3, including BSS, FEF, FFW, FHT, FPD.
- BSS
- FEF
- FFW
- FHT
- FPD
- KGC
- KNT Tubes, Gastrointestinal (And Accessories)
- PIF Gastrointestinal Tubes With Enteral Specific Connectors
- PIO
- PNR Enteral Syringes With Enteral Specific Connectors
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.