International Organization for Standardization (ISO)
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ISO 10940:2009
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.
ISO 10940:2009 Referenced Document
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 15004-1 Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments*, 2020-06-04 Update
ISO 15004-2:2007 Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection