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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
Section 1.2. Collateral standard electromagnetic
compatibility requirements
EN 55011 (Class B) Limits and methods of measurements for radio
interference characteristics of industrial,
scientific, and medical equipment
IEC 1000-3-2 Harmonic emissions
IEC 1000-3-3 Voltage fluctuations/flicker emissions
IEC 1000-4-2 Electrostatic discharge requirements for
industrial process measurement and control
equipment
IEC 1000-4-3 Radiated electromagnetic field requirements for
industrial process measurement and control
equipment
IEC 1000-4-4 Electrically fast transients for industrial process
measurement and control equipment
IEC 1000-4-5 Surge requirements
IEC 1000-4-11 Voltage variations/dips/interrupts
IEC 1000-4-6 Conducted immunity
IEC 1000-4-8 Magnetic field immunity
Conformance to the Medical Device Directive
93/42/EEC
EN 60601-1 Medical
Electrical Equipment
Part 1: General requirements for safety