GE MEDICAL SYSTEMS
D
IRECTION FK091075, REVISION 04 VIVID 3N PRO/EXPERT SERVICE MANUAL
Chapter 1 Introduction 1-17
1-10-3 Standards Used
To fulfill the requirements of relevant EC directives and/or European Harmonized/International
standards, the following documents/standards have been used:
NOTE: For CE Compliance, it is critical that all covers, screws, shielding, gaskets, mesh and clamps are in good
condition and installed tightly without skew or stress. Proper installation following all comments noted
in this service manual is required in order to achieve full EMC performance.
Table 1-6 Standards Used
Standard/Directive Scope
89/336/EEC EMC Directive.
93/42/EEC Medical Device Directive.
IEC 801-2 Electrostatic Discharge.
IEC 801-3 Radiated Electromagnetic Field.
IEC 801-4 Electrical Fast Transient/Burst.
IEC 805-1 Surge.
EN 55011/CISPR 11 Electromagnetic Susceptibility.
EN 60601-1/IEC 601-1/UL 2601-1 Medical Electrical Equipment; General Requirements for Safety.
EN 61157/ IEC 61157
Requirements for the declaration of the acoustic output of medical
diagnostic ultrasonic equipment.
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