FDA-recognized standard · Anesthesiology
ISO 18562-3: Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
Yes. FDA recognizes ISO 18562-3 Second Edition 2024-03 as recognition 1-175, entered 2024-05-29.
Recognized editions of ISO 18562-3
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 1-175 | ISO 18562-3 Second Edition 2024-03 | 2024-05-29 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 18562-3: 21 CFR 868.1400, 21 CFR 868.1840, 21 CFR 868.2885, 21 CFR 868.5160, 21 CFR 868.5260, 21 CFR 868.5270, 21 CFR 868.5330, 21 CFR 868.5340, 21 CFR 868.5440, 21 CFR 868.5454, 21 CFR 868.5580, 21 CFR 868.5620, 21 CFR 868.5630, 21 CFR 868.5690, 21 CFR 868.5730, 21 CFR 868.5800, 21 CFR 868.5895, 21 CFR 868.5905, 21 CFR 868.5915, 21 CFR 868.5975, 21 CFR 868.6250, 21 CFR 880.5400.
Product codes that cite ISO 18562-3
29 FDA product codes cite ISO 18562-3, including BSZ, BTI, BTM, BTR, BWF.
- BSZ
- BTI
- BTM
- BTR Tube, Tracheal (W/Wo Connector)
- BWF Spirometer, Therapeutic (Incentive)
- BXP
- BYG
- BYP
- BZD Ventilator, Non-Continuous (Respirator)
- BZE
- BZG Spirometer, Diagnostic
- BZO
- BZR
- CAF Nebulizer (Direct Patient Interface)
- CAH Filter, Bacterial, Breathing-Circuit
- CAT
- CAW Generator, Oxygen, Portable
- CBK Ventilator, Continuous, Facility Use
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- FMZ
- JOH
- MNS
- MNT
- NFB
- NHJ
- NOU
- NVP
- PNV
- 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.