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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 27740:1992

Medical devices Directive (93/42/EEC)

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

EN 20594-1:1993/AC:1996

Medical devices Directive (93/42/EEC)

Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (...

EN ISO 22523:2006

Medical devices Directive (93/42/EEC)

External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)

EN ISO 21987:2009

Medical devices Directive (93/42/EEC)

Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009)

EN ISO 21969:2009

Medical devices Directive (93/42/EEC)

High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)

EN ISO 21649:2009

Medical devices Directive (93/42/EEC)

Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)

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

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

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