BS EN 1641:2009
Dentistry - Medical devices for dentistry - Materials

Standard No.

BS EN 1641:2009

Release Date

2009

Published By

British Standards Institution (BSI)

Latest

BS EN 1641:2009

Replace

08/30184612 DC-2008 BS 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 and orthodontic materials. Dental implants are specifically excluded and described in EN 1642. This standard also specifies general requirements for materials used in the practice of orthodontics. 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.

BS EN 1641:2009 Referenced Document

• EN 1041 Information supplied by the manufacturer of medical devices*， 2013-09-01 Update
• EN 21563 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 9693 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems (ISO 9693:2019)*， 2019-11-20 Update
• EN ISO 9917 Dentistry - Water-based cements - Part 2: Resin-modified cements*， 2017-09-01 Update

BS EN 1641:2009 history

• 2009 BS EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
• 2004 BS EN 1641:2004 Dentistry - Medical devices for dentistry - Materials