EN 1641:2004

Dentistry - Medical devices for dentistry - Materials EN 1641:2004

Publication date:   Aug 10, 2006

General information

99.60 Withdrawal effective   Oct 28, 2009

CEN

CEN/TC 55 Dentistry

European Norm

11.060.10   Dental materials

Buying

Withdrawn

Language in which you want to receive the document.

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN 1641:1996

NOW

WITHDRAWN
EN 1641:2004
99.60 Withdrawal effective
Oct 28, 2009

REVISED BY

PUBLISHED
EN 1641:2009