| ISO 15752 Second edition 2010-01-15 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety |
| Recognition Date | 2011-08-02 |
| Recognition List | 027 |
| Recognition Number | 10-65 |
| 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 International Standard specifies optical radiation safety aspects of endoilluminator light sources and endoilluminator light guides which are used to illuminate the interior of the eye during ocular surgery.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.4150 | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Class 2 | HQE |
| §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. |