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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 13976-2:2011

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EN ISO 21987:2017

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Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2017)

EN ISO 22442-1:2020

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Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

EN ISO 14607:2018

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)

EN ISO 14155:2020

Medical devices Directive (93/42/EEC)

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

EN ISO 11607-2:2020

Medical devices Directive (93/42/EEC)

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

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