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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 4135:2001

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)

EN 14079:2003

Medical devices Directive (93/42/EEC)

Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose...

EN ISO 13408-6:2011

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

EN ISO 13408-7:2015

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

EN ISO 13485:2016

Medical devices Directive (93/42/EEC)

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

EN ISO 13485:2016/AC:2016

Medical devices Directive (93/42/EEC)

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

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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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