| ISO 10940 Second edition 2009-08-01 Ophthalmic instruments - Fundus cameras |
| Recognition Number | Ophthalmic |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 10-74 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Sub-clause 4.4 Optical radiation hazard with fundus cameras |
| 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 standard is recognized in part because: Sub-clause 4.4 is in conflict with another recognized standard, see ANSI Z80.36 listed below.
This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for fundus cameras operating for observing, photographing or recording electronic images of the fundus of the human eye in order to provide the image information for diagnosis. This International Standard is not applicable to the following instruments:
- those that contact the eye during the examination;
- those using scanning laser sources.
This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.1120 | Camera, Ophthalmic, Ac-Powered | Class 2 | HKI |
| ANSI Z80.36 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments |