BS EN 1641:2009

This standard BS EN 1641:2009 Dentistry. Medical devices for dentistry. Materials is classified in these ICS categories:

• 11.060.10 Dental materials

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.