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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 12006-2:1998+A1:2009

Medical devices Directive (93/42/EEC)

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including c...

EN ISO 15883-3:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste contai...

EN ISO 17665-1:2006

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a...

EN ISO 17664:2004

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical dev...

EN ISO 17510-2:2009

Medical devices Directive (93/42/EEC)

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

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)

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