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 withThis standard are contained in the level 3 standards, if appropriate.
EN 1640:2009 Referenced Document
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments
EN 21942-1:1991 Dental Vocabulary - Part 1: General and Clinical Terms
EN 21942-4:1993 Dental vocabulary Part 4: Dental equipment ISO 1942-4: 1989
EN 60601-1-4:1996 Medical Electrical Equipment; Part 1: General Requirements for Safety 4. Collateral Standard: Programmable Electrical Medical Systems
EN 60601-1:2006 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (Incorporates Amendment A12: 2014)
EN 60601-2-22:1996 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment
EN 60825-1:1994 Safety of Laser Products; Part 1: Equipment Classification@ Requirements and User's Guide (Incorporating Corrigendum February 1995; Incorporates Amendment A11: 1996)
EN 62304:2006 Medical device software - Software life-cycle processes (Incorporating corrigendum November 2008)
EN ISO 6875:1996 Dental Equipment - Dental Patient Chair ISO 6875 : 1995