Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments

Document Number: NL ISO 15004 1 : 2012
Sector: Medical Devices
TC: NL TC 3001
ICS: 11.040.70
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.