FDA-recognized standard · Anesthesiology
ISO 5356-1: Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
Yes. FDA recognizes ISO 5356-1 Third edition 2004-05-15 as recognition 1-62, entered 2012-03-16.
Recognized editions of ISO 5356-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 1-62 | ISO 5356-1 Third edition 2004-05-15 also ANSI AAMI ISO 5356-1:2004 | 2012-03-16 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 5356-1: 21 CFR 868.5160, 21 CFR 868.5240, 21 CFR 868.5260, 21 CFR 868.5375, 21 CFR 868.5450, 21 CFR 868.5720, 21 CFR 868.5730, 21 CFR 868.5740, 21 CFR 868.5800, 21 CFR 868.5810, 21 CFR 868.5870, 21 CFR 868.5895, 21 CFR 868.5905, 21 CFR 868.5915, 21 CFR 868.5925, 21 CFR 868.5965, 21 CFR 868.5975.
Product codes that cite ISO 5356-1
20 FDA product codes cite ISO 5356-1, including BSZ, BTL, BTM, BTO, BTR.
- BSZ
- BTL
- BTM
- BTO
- BTR Tube, Tracheal (W/Wo Connector)
- BTS
- BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
- BYD
- BYE
- BZA
- BZD Ventilator, Non-Continuous (Respirator)
- BZO
- CAH Filter, Bacterial, Breathing-Circuit
- CAI
- CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- CBK Ventilator, Continuous, Facility Use
- CBP
- JOH
- MNS
- MNT
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.