FDA-recognized standard · ObGyn/Gastroenterology/Urology
IEC 60601-2-18: Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Yes. FDA recognizes IEC 60601-2-18: Edition 3.0 2009-08 as recognition 9-114, entered 2018-06-07.
Recognized editions of IEC 60601-2-18
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 9-114 | IEC 60601-2-18: Edition 3.0 2009-08 | 2018-06-07 | Complete | — |
Regulations
FDA lists these classification regulations against IEC 60601-2-18: 21 CFR 874.4350, 21 CFR 874.4680, 21 CFR 874.4710, 21 CFR 874.4720, 21 CFR 874.4750, 21 CFR 874.4760, 21 CFR 874.4770.
Product codes that cite IEC 60601-2-18
7 FDA product codes cite IEC 60601-2-18, including EOB, EOQ, EOX, EQH, EQL.
- EOB Nasopharyngoscope (Flexible Or Rigid)
- EOQ Bronchoscope (Flexible Or Rigid)
- EOX Esophagoscope (Flexible Or Rigid)
- EQH
- EQL
- ERA
- EWY
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.