BS EN 1639:2009
Dentistry - Medical devices for dentistry - Instruments

Standard No.

BS EN 1639:2009

Release Date

2009

Published By

British Standards Institution (BSI)

Latest

BS EN 1639:2009

Replace

08/30184602 DC-2008 BS EN 1639:2004

Scope

This European Standard specifies general requirements for instruments used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, reprocessing, packaging, marking, labelling, and information supplied by the manufacturer. This European Standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by EN 1640. Tests for demonstrating compliance with this European Standard are contained in the level 3 standards, if appropriate.

BS EN 1639:2009 Referenced Document

• EN 1041 Information supplied by the manufacturer of medical devices*， 2013-09-01 Update
• EN 13060 Small steam sterilizers*， 2014-12-01 Update
• EN 1640 Dentistry - Medical devices for dentistry - Equipment*， 2024-04-19 Update
• EN 21942-1:1991 Dental Vocabulary - Part 1: General and Clinical Terms
• EN 21942-3:1993 Dental Vocabulary - Part 3: Dental Instruments (ISO 1942-3:1989)
• EN 23964 Dentistry - Dental handpieces - Coupling dimensions (ISO 3964:1982); Corrigendum 1
• EN 29168 Dental Handpieces - Hose Connectors (ISO 9168 : 1991)
• EN 556-1 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-19 Update
• EN 60601-1 Medical electrical equipment - Part 1: General requirements for safety
• EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
• EN ISO 1797-1 Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals*， 2011-08-01 Update
• EN ISO 1797-2 Dental rotary instruments - Shanks - Part 2: Shanks made of plastics
• EN ISO 2157 Dentistry - Nominal diameters and designation code numbers for rotary instruments*， 2016-05-01 Update
• EN ISO 3630-1 Dentistry - Endodontic instruments - Part 1: General requirements (ISO 3630-1:2019)*， 2019-10-09 Update
• EN ISO 3630-2 Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2023)*， 2023-02-15 Update
• EN ISO 3630-3 Dentistry - Endodontic instruments - Part 3: Compactors (ISO 3630-3:2021)*， 2021-05-31 Update
• EN ISO 3823-1 Dental Rotary Instruments - Burs - Part 1: Steel and Carbide Burs ISO 3823-1:1997; Supersedes EN 23823-1:1991
• EN ISO 3823-2 Dentistry - Rotary bur instruments - Part 2: Finishing burs - Amendment 1 (ISO 3823-2:2003/Amd 1:2008)
• EN ISO 7153-1 Surgical instruments - Materials - Part 1: Metals*， 2016-10-01 Update
• EN ISO 7492 Dentistry - Dental explorer (ISO 7492:2019)*， 2019-05-01 Update
• EN ISO 7711-1 Dentistry - Diamond rotary instruments - Part 1: General requirements - Amendment 1 (ISO 7711-1:2021/DAM 1:2024)

BS EN 1639:2009 history

• 2009 BS EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
• 2004 BS EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments