FDA-recognized standard · Anesthesiology
ISO 4135: Anaesthetic and respiratory equipment - Vocabulary
Yes. FDA recognizes ISO 4135 Fourth edition 2022-01 as recognition 1-189, entered 2024-12-23.
Recognized editions of ISO 4135
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 1-189 | ISO 4135 Fourth edition 2022-01 | 2024-12-23 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 4135: 21 CFR 866.6090, 21 CFR 868.1870, 21 CFR 868.1965, 21 CFR 868.2300, 21 CFR 868.2350, 21 CFR 868.2875, 21 CFR 868.5250, 21 CFR 868.5270, 21 CFR 868.5340, 21 CFR 868.5450, 21 CFR 868.5454, 21 CFR 868.5460, 21 CFR 868.5630, 21 CFR 868.5640, 21 CFR 868.5710, 21 CFR 868.5760, 21 CFR 868.5795, 21 CFR 868.5800, 21 CFR 868.5895, 21 CFR 868.5905, 21 CFR 868.5915, 21 CFR 868.5925, 21 CFR 868.5955, 21 CFR 868.6810, 21 CFR 870.2200, 21 CFR 870.5050, 21 CFR 876.4680.
Product codes that cite ISO 4135
40 FDA product codes cite ISO 4135, including BSY, BTL, BTM, BTT, BXW.
- BSY
- BTL
- BTM
- BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
- BXW
- BXY
- BYR
- BZD Ventilator, Non-Continuous (Respirator)
- BZE
- CAF Nebulizer (Direct Patient Interface)
- CAG
- CAT
- CBG
- CBK Ventilator, Continuous, Facility Use
- CBO
- CCN
- CCQ
- DWM
- EPE
- FNC
- JFE
- KFZ
- LSZ
- MNS
- MNT
- MOD
- NOU
- NQV
- NQY
- NVO
- NXA
- OEV
- OGG
- ONZ
- QAV
- QAZ
- QKS
- QOT
- QOV
- QUO
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.