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EN 1642:2011 Standard

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  Keywords:

#standard #european #requirements #dental #materials

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Dentistry - Medical devices for dentistry - Dental implants

  Purpose

This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 1642:2009"

Anyway is still possible use the "EN 1642:2009" until April 30th, 2012

  Related Standards

EN ISO 13485:2016/AC:2018

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EN 60601-2-8:1997

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

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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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