EN 1642 Dentistry, Medical Devices for Dentistry, Dental Implants Test Standard

Medical Device Tests

EN 1642 Dentistry, Medical Devices for Dentistry, Dental Implants Test Standard

EUROLAB laboratory provides testing and compliance services within the scope of EN 1642 standard. This European standard specifies the general requirements for dental implants and accessories. Surgically implantable dental materials, defined as restorative materials, are specifically excluded and described in EN 1641.

EN 1642 Dentistry, Medical Devices for Dentistry, Dental Implants Test Standard

This European standard contains requirements for intended performance, design features, components, sterilization, packaging, marking, labeling and information provided by the manufacturer.

Dental implants shall comply with the requirements applicable to them, taking into account the intended use of the implant.

Dental implants will be manufactured under conditions that will minimize microbial or other contamination. The state in which the dental implants are procured should be clearly stated, ie sterile, non-sterile.

EUROLAB assists manufacturers with EN 1642 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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