SRPS EN ISO 15004-1:2012

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

Scope

ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 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.
ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.