scope:

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.