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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

Medical devices Directive (93/42/EEC)

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

EN ISO 15798:2010

Medical devices Directive (93/42/EEC)

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)

EN ISO 17510-1:2009

Medical devices Directive (93/42/EEC)

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

EN ISO 16201:2006

Medical devices Directive (93/42/EEC)

Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)

EN ISO 16061:2009

Medical devices Directive (93/42/EEC)

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version...

EN 15986:2011

Medical devices Directive (93/42/EEC)

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

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