prEN 1641 rev

Dentistry - Medical devices for dentistry - Materials

General information

30.98 Project deleted   Apr 24, 2018

CEN

CEN/TC 55 Dentistry

European Norm

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 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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

Revises
EN 1641:2009

NOW

ABANDON
prEN 1641 rev
30.98 Project deleted
Apr 24, 2018