FDA-recognized standard · Anesthesiology
ISO 80369-2: Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications
Yes. FDA recognizes ISO 80369-2 First edition 2024-09 as recognition 1-195, entered 2025-05-26.
Recognized editions of ISO 80369-2
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 1-195 | ISO 80369-2 First edition 2024-09 | 2025-05-26 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 80369-2: 21 CFR 868.1400, 21 CFR 868.1500, 21 CFR 868.1620, 21 CFR 868.1700, 21 CFR 868.1720, 21 CFR 868.2340, 21 CFR 868.5340.
Product codes that cite ISO 80369-2
10 FDA product codes cite ISO 80369-2, including CAT, CAX, CBQ, CBR, CBS.
- CAT
- CAX
- CBQ
- CBR
- CBS
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCL
- NHO
- NHP
- NHQ
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.