EN ISO 15004-1:2009

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

Publication date:   Feb 28, 2010

General information

99.60 Withdrawal effective   Nov 25, 2020

CEN

CEN/TC 170 Ophthalmic optics

European Norm

11.040.70   Ophthalmic equipment

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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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15004-1:2006

NOW

WITHDRAWN
EN ISO 15004-1:2009
99.60 Withdrawal effective
Nov 25, 2020

REVISED BY

PUBLISHED
EN ISO 15004-1:2020

Relations

Adopted from ISO 15004-1:2006 IDENTICAL