| ISO 15004-1 First edition 2006-06-01 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 10-72 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Ophthalmic |
| FDA Tech | Dexiu Shi FDA/OMPT/CDRH/ODE/DOED/DSDB/ 301-796-6470 dexiu.shi@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This part of ISO 15004 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This part of ISO 15004 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
This part of ISO 15004 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.4690 | Photocoagulator And Accessories | Class 2 | HQB |
| §886.4670 | Laser, System, Phacolysis | Class 2 | MXO |
| §886.4392 | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla | Class 2 | LXS |
| §886.4390 | Laser, Ophthalmic | Class 2 | HQF |
| §886.4150 | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Class 2 | HQE |
| §886.3600 | Intraocular Lens | Class 3 | HQL |
| §886.3600 | Lens, Multifocal Intraocular | Class 3 | MFK |
| §886.1850 | Biomicroscope, Slit-Lamp, Ac-Powered | Class 2 | HJO |
| §886.1850 | Device, Analysis, Anterior Segment | Class 2 | MXK |
| §886.1850 | Microscope, Specular | Class 2 | NQE |
| §886.1780 | Retinoscope, Ac-Powered | Class 2 | HKL |
| §886.1780 | Retinoscope, Battery-Powered | Class 1 | HKM |
| §886.1570 | Ophthalmoscope, Ac-Powered | Class 2 | HLI |
| §886.1570 | Ophthalmoscope, Battery-Powered | Class 2 | HLJ |
| §886.1570 | Ophthalmoscope, Laser, Scanning | Class 2 | MYC |
| §886.1120 | Camera, Ophthalmic, Ac-Powered | Class 2 | HKI |
| §876.1500 | Endoilluminator | Class 2 | MPA |
| §876.1500 | Endoilluminator, Reprocessed | Class 2 | NKZ |
| §874.4350 | Source, Carrier, Fiberoptic Light | Class 1 | EQH |
| There is no relevant guidance developed at this time. |