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EVS-EN 1641:2009

Dentistry - Medical devices for dentistry - Materials

General information
Valid from 06.01.2010
Base Documents
EN 1641:2009
Directives or regulations
93/42/EEC Medical devices (MDD)
Standard history
Status
Date
Type
Name
06.01.2010
Main
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.
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