FDA-recognized standard · Anesthesiology
ISO 80601-2-55: Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor [Including Amendment 1 (2023)].
Yes. FDA recognizes ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] as recognition 1-184, entered 2024-12-23. FDA also lists ISO 80601-2-55 Second edition 2018-02 (recognition 1-140, transition period ending 2026-12-20).
Recognized editions of ISO 80601-2-55
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 1-184 | ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] | 2024-12-23 | Complete | — |
| 1-140 | ISO 80601-2-55 Second edition 2018-02 | 2018-09-17 | Complete | 2026-12-20 |
Regulations
FDA lists these classification regulations against ISO 80601-2-55: 21 CFR 868.1400, 21 CFR 868.1500, 21 CFR 868.1620, 21 CFR 868.1700, 21 CFR 868.1720.
Product codes that cite ISO 80601-2-55
8 FDA product codes cite ISO 80601-2-55, including CBQ, CBR, CBS, CCK, CCL.
- 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.