This part of ISO 15004 specifies fundamental requirements for non-invasive, active and non-active ophthalmic
instruments. This part of ISO 15004 is also applicable to low-vision aids and tonometers, but not to other
ophthalmic instruments which are used in contact with the globe of the eye.
This part of ISO 15004 is not applicable to operation microscopes, endoscopes and devices intended for laser
investigation or laser treatment of the eye.