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EN 1639:2009 Standard

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  Keywords:

#standard #european #energy #requirements #practice

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Dentistry - Medical devices for dentistry - Instruments

  Purpose

This European Standard specifies general requirements for instruments used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, reprocessing, packaging, marking, labelling, and information supplied by the manufacturer. This European Standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by EN 1640. Tests for demonstrating compliance with this European Standard are contained in the level 3 standards, if appropriate.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 1639:2004"

Anyway is still possible use the "EN 1639:2004" until April 30th, 2010

  Related Standards

EN ISO 13485:2016/AC:2018

Medical devices Directive (93/42/EEC)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN 60601-2-19:2009

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EN 60601-2-8:1997

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Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the rang...

EN 60601-2-8:1997/A1:1997

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the rang...

EN 60601-2-10:2000

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulatorsIEC 60601-2-10:198...

EN 60601-2-10:2000/A1:2001

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulatorsIEC 60601-2-10:198...

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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 1639:2009 STANDARD

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