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
The data 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
In the opinion of Planar Systems, Inc. registration required to put this device into commerce is the responsibility of the medical device/system manufacturer, and Planar supports this requirement by providing a European Commission (EC) declaration of conformity. If Planar 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.
For vigilance reporting as required under Article 10 of the MDD, Planar Systems, Inc. will provide any information requested by competent authority to support any reported incident investigation by such an authority.
European Union Declaration of Conformity for Medical Applications
A Declaration of Conformity has been filed for this product. For additional copies of the Declaration of Conformity document, please contact Planar Systems, Inc. and request document number
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