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EN ISO 15004-1:2009 Standard

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  Keywords:

#part #eye #laser #instruments #active

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

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

  Purpose

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.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN ISO 15004-1:2006"

Anyway is still possible use the "EN ISO 15004-1:2006" until March 21st, 2010

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