FDA-recognized standard · General I (QS/RM)
ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Yes. FDA recognizes ISO 80369-7 Second edition 2021-05 as recognition 5-133, entered 2020-12-21.
Recognized editions of ISO 80369-7
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 5-133 | ISO 80369-7 Second edition 2021-05 | 2020-12-21 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 80369-7: 21 CFR 880.5570, 21 CFR 880.5860.
Product codes that cite ISO 80369-7
3 FDA product codes cite ISO 80369-7, including FMF, FMI, MEG.
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.