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Regulatory Compliance
Canada, European Union, United States
This display has been tested
and found to comply with
IEC/UL/EN 60601-1 and IEC
60601-1-2 standards, and is
certified to meet medical
standard UL 60601-1 and CAN/CSA C22.2 No 601.1(C US Mark) which
are related to electrical shock, fire and mechanical hazards only as
shown on right UL mark on this page.
The medical display, in addition to meeting medical requirements, has
been tested and found to comply with the limits for Federal
Communications Commission (FCC) Class B computing devices in a
typically configured system since many medical offices are located in
residential areas. It is the system integrator’s responsibility to test and
ensure that the entire system complies with applicable
electromagnetic compatibility (EMC) laws.
Barco NV has made great efforts to support the medical device industry,
in particular, medical device manufacturers and medical device system
integrators. We offer state-of-the-art color displays that are compliant
with worldwide accepted medical device safety standards, and for the
European market, CE-marked displays based on compliance with
counsel directive 93/42/EEC—commonly referred to as the Medical
Device Directive (MDD). The following summarizes our qualification of
these displays as it relates to compliance with the MDD.
The European Medical Device Directive requires that the intended use
of the device be defined. The intended use of these displays is “to
display alphanumeric, graphic, and image data as inputted from any
type of medical device.” These displays do not provide a measurement
function in any way, and it is the device and systems manufacturer’s
responsibility to verify its function in the integrated device or system.