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.
BS EN ISO 10943:2011 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