Planar Dome C3i/EX User Manual page 56

The display was classified as required by the MDD according to Annex IX of
the directive and the medical device (MEDDEV) guidance available at the
time of classification. Because the display uses electrical energy and has no
direct patient connections and—by itself—no medical utility, the display
is classified according to Rule 12 as an MDD Class I device, component, or
accessory. The MDD states that manufacturers of Class I medical devices
or accessories shall satisfy the requirements in regard to design and
manufacturing controls, that is, the applicable assessment route to be used
for CE-marking under the MDD, and it shall carry the CE mark according to
Annex XII of the directive, with no notified body annotation.
The applicable safety standards for an MDD Class I display are IEC/EN
60601-1:1990 along with Amendments 1 and 2. To help the medical device
designer evaluate the suitability of these displays, Planar has also conducted
EMC testing to IEC 60601-1-2 as it can be applied. The display with its power
supply alone does not represent a functional medical device. Hence, Planar
configured a minimal operating system to exercise the display. The resulting
data are made available to interested parties.
This is informative data, not certification data. Certification data must be
obtained by the device or system integrator according to Article 12 of
the MDD titled "Particular procedure for systems and procedure packs."
Paragraph 2 clearly outlines the device or system integrator's responsibility
in this matter.
In summary, Planar Systems, Inc. is CE-marking these displays under the
Medical Device Directive, which establishes compliance to the basic medical
safety standards. However, EMC compliance can only be accomplished in the
configured medical device or system and is the responsibility of the device or
system manufacturer. Planar has the necessary documentation such as IEC
60601-1 notified body and other third-party test reports and certifications,
a risk/hazard analysis, an essential requirements checklist, and the Planar
International Electrotechnical Commission (IEC) declaration of conformity.