BS EN ISO 10943:2011 PDF

1   Scope 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.