DIN EN 1641:2010
Dentistry - Medical devices for dentistry - Materials; German version EN 1641:2009

Standard No.

DIN EN 1641:2010

Release Date

2010

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN 1641:2010-02

Latest

DIN EN 1641:2010-02

Replace

DIN EN 1641:2008 DIN EN 1641:2004

Scope

This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.

DIN EN 1641:2010 Referenced Document

• EN 1041 Information supplied by the manufacturer of medical devices*， 2013-09-01 Update
• EN 21563:1991 Alginate Dental Impression Material
• EN 21942-1:1991 Dental Vocabulary - Part 1: General and Clinical Terms
• EN 21942-2:1992 Dental Vocabulary - Part 2: Dental Materials
• EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
• EN ISO 1564 Dental Aqueous Impression Materials Based on Agar ISO 1564:1995; Supersedes EN 21564:1990
• EN ISO 1942-5:1994 Dental Vocabulary - Part 5: Terms Associated with Testing (ISO 1942-5:1989)
• EN ISO 3107 Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements (ISO 3107:2022)*， 2022-10-19 Update
• EN ISO 4049 Dentistry - Polymer-based restorative materials (ISO 4049:2019)*， 2019-06-19 Update
• EN ISO 4823 Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2021)*， 2021-02-28 Update
• EN ISO 6872 Dentistry - Ceramic materials (ISO 6872:2015/Amd 1:2018)*， 2018-05-23 Update
• EN ISO 6873 Dentistry - Gypsum products*， 2013-04-01 Update
• EN ISO 6874 Dentistry - Polymer-based pit and fissure sealants*， 2015-09-01 Update
• EN ISO 6876 Dentistry - Root canal sealing materials (ISO 6876:2012)*， 2012-07-01 Update
• EN ISO 6877 Dentistry - Endodontic obturating materials (ISO 6877:2021)*， 2021-08-31 Update
• EN ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)*， 2018-11-28 Update
• EN ISO 7491 Dental Materials - Determination of Colour Stability ISO 7491:2000; Supersedes EN 27491:1991
• EN ISO 7551 Dentistry - Endodontic absorbent points (ISO 7551:2023)*， 2023-05-17 Update
• EN ISO 9333 Dentistry - Brazing materials (ISO 9333:2022)*， 2022-10-05 Update
• EN ISO 9653 Adhesives - Test Method for Shear Impact Strength of Adhesives Bonds ISO 9653: 1998; Supersedes EN 29653: 1994

DIN EN 1641:2010 history

• 2010 DIN EN 1641:2010-02 Dentistry - Medical devices for dentistry - Materials; German version EN 1641:2009
• 2010 DIN EN 1641:2010 Dentistry - Medical devices for dentistry - Materials; German version EN 1641:2009
• 0000 DIN EN 1641:2008
• 0000 DIN EN 1641:2004