This European Standard specifies general requirements for 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 apply to 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 EN 1639.
Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.
Legislation related to this standard
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
WITHDRAWN
EN 1640:2004
PUBLISHED
EN 1640:2009
90.93
Standard confirmed
May 22, 2024