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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 14889:2009

Medical devices Directive (93/42/EEC)

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)

EN ISO 9713:2009

Medical devices Directive (93/42/EEC)

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)

EN ISO 7396-2:2007

Medical devices Directive (93/42/EEC)

Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

EN ISO 7886-3:2009

Medical devices Directive (93/42/EEC)

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

EN ISO 7886-4:2009

Medical devices Directive (93/42/EEC)

Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

EN ISO 8185:2009

Medical devices Directive (93/42/EEC)

Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)

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