SK EN 1641:2013

Stomatologjia -Pajisje mjekësore për stomatologjinë -Materiale

Dentistry - Medical devices for dentistry - Materials

Asnjë informacion i shtuar.

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.

SK EN 1641:2017 replaces SK EN 1641:2013 - 2016-07-22