Skip to main content
Back

EVS-EN 1641:2009

Dentistry - Medical devices for dentistry - Materials

General information

Valid from 06.01.2010
Base Documents
EN 1641:2009
Directives or regulations
None

Standard history

Status
Date
Type
Name
06.01.2010
Main
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.

Required fields are indicated with *

*
*
*
PDF
12.20 € incl tax
Paper
12.20 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 22794:2009

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
Newest version Valid from 03.12.2009
Main

EVS-EN ISO 14801:2016

Dentistry - Implants - Dynamic loading test for endosseous dental implants (ISO 14801:2016)
Newest version Valid from 06.12.2016
Main

EVS-EN ISO 7405:2018

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
Newest version Valid from 19.12.2018
Main

EVS-EN ISO 10993-5:2009

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Newest version Valid from 07.08.2009