EN ISO 15004-2:2007

Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2007) EN ISO 15004-2:2007

Publication date:   Jun 28, 2007

General information

60.60 Standard published   Feb 15, 2007

CEN

CEN/TC 170 Ophthalmic optics

European Norm

11.040.70   Ophthalmic equipment

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Scope

ISO 15004-2:2007 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective International Standards. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye.
ISO 15004-2:2007 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye.
ISO 15004-2:2007 classifies ophthalmic instruments into either Group 1 or a Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15004:1997

NOW

PUBLISHED
EN ISO 15004-2:2007
60.60 Standard published
Feb 15, 2007

REVISED BY

IN_DEVELOPMENT
prEN ISO 15004-2