EN 61010-2-101 Measurement, Control and Laboratory Use, Safety Requirements for Electrical Equipment, Part 2-101: In Vitro Diagnostic (IVD) Medical Equipment

Medical Device Tests

EN 61010-2-101 Measurement, Control and Laboratory Use, Safety Requirements for Electrical Equipment, Part 2-101: In Vitro Diagnostic (IVD) Medical Equipment

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN 61010-2-101 testing. EN 61010-2-101 applies to equipment for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.

EN 61010-2-101 Measurement, Control and Laboratory Use, Safety Requirements for Electrical Equipment, Part 2-101: In Vitro Diagnostic (IVD) Medical Equipment

IVD medical equipment, whether used alone or in combination, is intended by the manufacturer for use solely or primarily to provide information about an individual for the in vitro examination of specimens obtained from the human body, including blood and tissue specimens.

Self-testing IVD medical equipment is designed by the manufacturer for use by ordinary people in the home environment.

If all or part of the equipment falls within the scope of one or more other part 61010 standards of IEC 2, as well as within the scope of this standard, these other part 2 standards should also be considered.

EUROLAB assists manufacturers with EN 61010-2-101 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.

Get Offer Now

To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.

WhatsApp