scope:

This European Standard specifies general requirements for items of dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer. This European Standard does not include requirements for dental X-ray equipment. This European Standard does not apply to any dental instruments connected to an item of dental equipment. These instruments are covered by the level 2 and level 3 standards for dental instruments. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.