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

SS-EN-ISO-15004-1 - 2009 EDITION - CURRENT
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This part of ISO 15004 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This part of ISO 15004 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. This part of ISO 15004 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

To find similar documents by classification:

11.040.70 (Ophthalmic equipment Including ophthalmic implants, glasses, contact lenses and their cleaning products)

Medical devices

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Designation Name

SS-EN ISO 15004-1:2009

Revision Level




Publication Date

April 20, 2009



Page Count


International Equivalent

EN ISO 15004-1:2009(IDT); ISO 15004-1:2006(IDT)