BS EN 1640:2009 PDF

Standard No.: BS EN 1640:2009
Release Date: 2009
Published By: British Standards Institution (BSI)
Latest: BS EN 1640:2009
Replace: BS EN 1640:2004 08/30184608 DC-2008

Scope: 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.

BS EN 1640:2009 Referenced Document

EN 1041 Information supplied by the manufacturer of medical devices*， 2013-09-01 Update
EN 1639 Dentistry - Medical devices for dentistry - Instruments*， 2024-04-19 Update
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 Medical electrical equipment - Part 1: General requirements for safety
EN 60601-1-4 Medical Electrical Equipment; Part 1: General Requirements for Safety 4. Collateral Standard: Programmable Electrical Medical Systems
EN 60825-1 Safety of laser products - Part 1: Equipment classification and requirements*， 2019-03-01 Update
EN 62304 Medical device software - Software life-cycle processes (Incorporating corrigendum November 2008)
EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
EN ISO 10637 Dentistry - Central suction source equipment*， 2018-06-01 Update
EN ISO 10650-2 Dentistry - Powered polymerization activators - Part 2: Lightemitting diode (LED) lamps
EN ISO 11143 Dentistry - Amalgam separators (ISO 11143:2008)
EN ISO 6875 Dentistry - Patient chair (ISO 6875:2011)*， 2011-07-01 Update
EN ISO 7488 Dentistry - Mixing machines for dental amalgam*， 2018-05-01 Update
EN ISO 7494-1 Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements*， 2018-07-01 Update
EN ISO 7494-2 Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2022)*， 2022-10-19 Update
EN ISO 9680 Dentistry - Operating lights (ISO 9680:2021)*， 2021-12-01 Update
EN ISO 9687 Dentistry - Graphical symbols for dental equipment (ISO 9687:2015/Amd 1:2018)*， 2018-05-02 Update

BS EN 1640:2009 history

2009 BS EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
2004 BS EN 1640:2004 Dentistry - Medical devices for dentistry - Equipment

Dentistry - Medical devices for dentistry - Equipment

BS EN 1640:2009Dentistry - Medical devices for dentistry - Equipment

BS EN 1640:2009 Referenced Document

BS EN 1640:2009 history

BS EN 1640:2009
Dentistry - Medical devices for dentistry - Equipment