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 withThis standard are contained in the level 3 standards, if appropriate.
EN 1641:2009 Referenced Document
EN 1041:2008 Information supplied by the manufacturer of medical devices