EN 1639 Dentistry - Testing for Medical Devices, Instruments

Medical Device Tests

EN 1639 Dentistry - Testing for Medical Devices, Instruments

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN 1639 testing. This standard specifies general requirements for instruments used in dental practice, which are medical devices.

EN 1639 Dentistry - Testing for Medical Devices, Instruments

It includes requirements for intended performance, design features, components, rework, packaging, marking, labeling and manufacturer-supplied information.

This European Standard does not apply to any required energy source to which a device must be connected. These energy sources are covered by EN 1640.

Tests demonstrating compliance with this European Standard are included in level 3 standards, if applicable.

EUROLAB assists manufacturers with EN 1639 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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