Planar Dome E2 User Manual page 37

EU Declaration of Conformity for Medical Application
A Declaration of Conformity has been filed for this product. For additional
copies of the Declaration of Conformity document, contact Planar Systems.
The Dome EX digital flat-panel display meets the essential health and safety
requirements, is in conformity with, and the CE marking has been applied
according to the relevant EU Directives listed below, using the relevant
section of the following EU standards and other normative documents;
EU EMC Directive 89/336/EEC
EU Electromagnetic Compatibility Directive
EN 60601-1-2 (2001)
Medical Electrical
Equipment
EN 55011 (Class B)
IEC 1000-3-2
IEC 1000-3-3
IEC 1000-4-2
IEC 1000-4-3
IEC 1000-4-4
IEC 1000-4-5
IEC 1000-4-11
IEC 1000-4-6
IEC 1000-4-8
EN 60601-1 Medical
Electrical
Equipment
Section 1.2. Collateral standard electromagnetic
compatibility requirements
Limits and methods of measurements for radio
interference characteristics of industrial, scientific,
and medical equipment
Harmonic emissions
Voltage fluctuations/flicker emissions
Electrostatic discharge requirements for industrial
process measurement and control equipment
Radiated electromagnetic field requirements for
industrial process measurement and control
equipment
Electrically fast transients for industrial process
measurement and control equipment
Surge requirements
Voltage variations/dips/interrupts
Conducted immunity
Magnetic field immunity
Conformance to the Medical Device Directive
93/42/EEC
Part 1: General requirements for safety