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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

  Related Standards

EN 60601-2-17:2004

Medical devices Directive (93/42/EEC)

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EN ISO 9360-1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HME...

EN ISO 10993-14:2009

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Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 1...

EN ISO 10993-4:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

EN ISO 10651-4:2009

Medical devices Directive (93/42/EEC)

Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

EN ISO 10651-2:2009

Medical devices Directive (93/42/EEC)

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilat...

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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 1640:2009 STANDARD

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