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EN 1641:2009 Standard

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  Keywords:

#standard #materials #requirements #used #general

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Dentistry - Medical devices for dentistry - Materials

  Purpose

This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative and orthodontic materials. Dental implants are specifically excluded and described in EN 1642. This standard also specifies general requirements for materials used in the practice of orthodontics. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. 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 1641:2004"

Anyway is still possible use the "EN 1641:2004" until April 30th, 2010

  Related Standards

EN ISO 25424:2019

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

EN 1642:2011

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Dental implants

EN ISO 21987:2017

Medical devices Directive (93/42/EEC)

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

EN 455-1:2000

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

EN 455-3:2006

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

EN 455-4:2009

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

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