FDA-recognized standard · General I (QS/RM)
ISO 18250-3: Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
Yes. FDA recognizes ISO 18250-3 First edition 2018-06 as recognition 5-139, entered 2022-12-19.
Recognized editions of ISO 18250-3
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 5-139 | ISO 18250-3 First edition 2018-06 | 2022-12-19 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 18250-3: 21 CFR 876.5980.
Product codes that cite ISO 18250-3
10 FDA product codes cite ISO 18250-3, 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.