FDA-recognized standard · Anesthesiology
ISO 80601-2-74: Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
Yes. FDA recognizes ISO 80601-2-74 Second edition 2021-07 as recognition 1-177, entered 2024-05-29. FDA also lists ISO 80601-2-74 First edition 2017-05 (recognition 1-138, transition period ending 2027-07-04).
Recognized editions of ISO 80601-2-74
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 1-177 | ISO 80601-2-74 Second edition 2021-07 | 2024-05-29 | Complete | — |
| 1-138 | ISO 80601-2-74 First edition 2017-05 | 2019-01-14 | Complete | 2027-07-04 |
Regulations
FDA lists these classification regulations against ISO 80601-2-74: 21 CFR 868.5270, 21 CFR 868.5450, 21 CFR 868.5454, 21 CFR 868.5895, 21 CFR 868.5905.
Product codes that cite ISO 80601-2-74
8 FDA product codes cite ISO 80601-2-74, including BTT, BZD, BZE, CBK, MNS.
- BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
- BZD Ventilator, Non-Continuous (Respirator)
- BZE
- CBK Ventilator, Continuous, Facility Use
- MNS
- MNT
- NOU
- QAV
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.