DIN EN 1639:2010
Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009

Standard No.

DIN EN 1639:2010

Release Date

2010

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN 1639:2010-02

Latest

DIN EN 1639:2010-02

Replace

DIN EN 1639:2008 DIN 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, sterilization, 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 the level 2 and level 3 standards, for dental equipment.Tests for demonstrating compliance with this European Standard are contained in the level 3 standards, if appropriate.

DIN EN 1639:2010 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 29168:1994 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)

DIN EN 1639:2010 history

• 2010 DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009
• 2010 DIN EN 1639:2010 Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009
• 0000 DIN EN 1639:2008
• 0000 DIN EN 1639:2004