GSO EN 1641:2021

Gulf Standard   Current Edition
Approved on  01 July 2021

Dentistry. Medical devices for dentistry. Materials

GSO EN 1641:2021 Files

English 7 Pages
Current Edition Reference Language

GSO EN 1641:2021 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.

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