Planar Dome EX manual EU Declaration of Conformity for Medical Application

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	Part 1: General requirements for safety
Electrical
Equipment