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EN 1640:2009 Standard

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  Keywords:

#dental #european #equipment #standard #instruments

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Dentistry - Medical devices for dentistry - Equipment

  Purpose

This European Standard specifies general requirements for dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer. This European Standard does not apply to dental X-ray equipment. This European Standard does not apply to any dental instruments connected to an item of dental equipment. These instruments are covered by EN 1639. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 1640:2004"

Anyway is still possible use the "EN 1640:2004" until April 30th, 2010

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CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN 1640:2009 STANDARD

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