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EVS-EN ISO 15004-1:2009

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments

General information
Withdrawn from 15.12.2020
Base Documents
ISO 15004-1:2006; EN ISO 15004-1:2009
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history
Status
Date
Type
Name
15.12.2020
Main
04.06.2009
Main
Main
EVS-EN ISO 15004-1:2006
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.
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