EN ISO 15004:1997

Ophthalmic instruments - Fundamental requirements and test methods (ISO 15004:1997)

Publication date:   Jan 22, 2004

General information

99.60 Withdrawal effective   Jun 1, 2006

CEN

CEN/TC 170 Ophthalmic optics

European Norm

11.040.70   Ophthalmic equipment

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Scope

This International Standard specifies Fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This International Standard 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 eyes. This International Standard takes precedence over the corresponding requirements of the other general standards cited in clause 2, if differences exist. This International Standard does not apply to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN ISO 15004:1997
99.60 Withdrawal effective
Jun 1, 2006

REVISED BY

WITHDRAWN
EN ISO 15004-1:2006

PUBLISHED
EN ISO 15004-2:2007