Dome Ex Display, Руководство пользователя

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Regulatory Compliance | 27
Furthermore, the applicable safety standards for an MDD Class IIa display are
EN 60601-1:2006 and IEC 60601-1:2005. To help the medical device designer
evaluate the suitability of this display, NDSsi 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, NDSsi 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, NDS Surgical Imaging 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. NDSsi has the necessary documentation such as
IEC 60601-1:2005, EN 60601-1:2006, and IEC/EN 60601-1-2 and third-
party test reports and certifications, a risk/hazard analysis, an essential
requirements checklist, and the NDS Surgical Imaging European Community
CE marking directive Declaration of Conformity.
NDS Surgical Imaging, located in San Jose, Calif., USA, is the manufacturer of
these displays in the meaning of the directive. As required by the MDD in
Article 14, NDS Surgical Imaging, not residing in the European Economic
Area (EEA), has a European representative, NDS Surgical Imaging —located at
Nijverheidscentrum 28, 2761 JP Zevenhuizen, The Netherlands (phone
+31-180-63-43-56; fax +31-180-63-21-91).
In the opinion of NDS Surgical Imaging registration required to put this
device into commerce is the responsibility of the medical device/system
manufacturer, and NDS Surgical Imaging supports this requirement by
providing a European Commission (EC) declaration of conformity. If NDS
Surgical Imaging supplies a display to an end user, rather than a device
manufacturer, it is the end user’s responsibility to ensure continued
compliance with the MDD of the system in which the display is integrated.
The supplier will make available on request, circuit diagrams, component part
lists, etc.
For vigilance reporting as required under Article 10 of the MDD, NDS Surgical
Imaging will provide any information requested by competent authority to
support any reported incident investigation by such an authority.