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

 

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Planar Dome EX manual EU Declaration of Conformity for Medical Application