Need help?

EN 1640:2009 Standard

wave
Save  

  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 60601-2-41:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaire...

EN 60601-2-36:1997

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotrips...

EN 60601-2-49:2001

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipmentIEC ...

EN 60601-2-47:2001

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory e...

EN 60601-2-46:1998

Medical devices Directive (93/42/EEC)

Medical electrical equipment -- Part 2-46: Particular requirements for the safety of operating tablesIEC 60601-2-46:1998

EN 60601-2-45:2001

Medical devices Directive (93/42/EEC)

Medical electrical equipment -- Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic...

  Stay up to date

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

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0