| ISO 10943 Third edition 2011-08-15 Ophthalmic instruments - Indirect ophthalmoscopes |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 10-70 |
| 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, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus.
This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.
This International Standard is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories.
This International Standard is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.1570 | Ophthalmoscope, Ac-Powered | Class 2 | HLI |
| §886.1570 | Ophthalmoscope, Laser, Scanning | Class 2 | MYC |
| Guidance for Industry Ophthalmoscope Guidance - (Direct and Indirect), Issued July 8, 1998 |