ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
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.
ISO 15004-1:2006 Referenced Document
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 15004-2 Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection*, 2007-02-01 Update
ISO 9022-2:2002 Optics and optical instruments - Environmental test methods - Part 2: Cold, heat and humidity
ISO 9022-3:1998 Optics and optical instruments - Environmental test methods - Part 3: Mechanical stress
ISO 15004-1:2006 history
2020ISO 15004-1:2020 Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments
2006ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments