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Medical safety standards

Medical safety standards

TOTOKU Medical Displays are certified under various medical safety standards in North America and EU countries, where medical equipment is subject to more stringent requirements than general IT devices, ensuring safety and reliability for use in medical facilities.

A closer look at each standard

UL

UL (Underwriters Laboratories, Inc.) is an independent nonprofit testing and certification organization established in the United States. TOTOKU medical image displays are certified under UL60601-1, CSA C22.2 N601.1, thus labeled with the UL Listing Marking.

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CE Marking

CE Marking is provided for products sold in European countries to indicate that the products conform to the EU Directive. Products from outside the EU sold into the EU market are required to include this CE Marking. TOTOKU medical imaging displays are certified under EN60601-1-1 (medical safety standard), EN60601-1-2 (medical EMC standard), conform to the Medical Device Directive (MDD), and are labeled with the CE Marking.

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FDA 510(k)

510(k), also known as Premarket Notification, refers to an application submitted to the Food and Drug Administration (FDA). It is an FDA national standard to allow a determination of the safety, effectiveness, and substantial equivalence of a device to a device already legally on the US market in the past or present. Its strict evaluation covers not only the safety and effectiveness of the device, but also proper labeling, including advertisements.

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