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SSH EN ISO 15004-2:2007

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

May 23, 2011

General information

60.60     May 23, 2011

DPS

DPS/KT 316

European Norm

11.040.70  

English  

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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 directives

Directives related to this standards.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 15004:2007

NOW

PUBLISHED
SSH EN ISO 15004-2:2007
60.60 Standard published
May 23, 2011

REVISED BY

IN_DEVELOPMENT
prSSH EN ISO 15004-2:2024

Related project

Adopted from EN ISO 15004-2:2007