FDA-recognized standard · Ophthalmic
ISO 15004-1: Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
Yes. FDA recognizes ISO 15004-1 Second edition 2020-5 as recognition 10-123, in part, entered 2021-06-07.
Recognized editions of ISO 15004-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 10-123 | ISO 15004-1 Second edition 2020-5 | 2021-06-07 | Partial | — |
What FDA does not recognize in ISO 15004-1 Second edition 2020-5
Recognition 10-123 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Section 2 (Normative references), reference to "ISO 15004-2:2007" Section 6.3 (Optical radiation hazard), reference to "ISO 15004-2" Section 8.1.d, reference to "ISO 15004-2:2007"
Regulations
FDA lists these classification regulations against ISO 15004-1: 21 CFR 874.4350, 21 CFR 886.1120, 21 CFR 886.1570, 21 CFR 886.1780, 21 CFR 886.1850.
Product codes that cite ISO 15004-1
11 FDA product codes cite ISO 15004-1, including EQH, HJO, HKI, HKL, HKM.
- EQH
- HJO
- HKI Camera, Ophthalmic, Ac-Powered
- HKL
- HKM
- HLI
- HLJ
- MSG
- MXK
- MYC
- OBO Tomography, Optical Coherence
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.