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GE M
S
EDICAL
YSTEMS
D
FK091075, R
IRECTION
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:
Table 1-6
89/336/EEC
93/42/EEC
IEC 801-2
IEC 801-3
IEC 801-4
IEC 805-1
EN 55011/CISPR 11
EN 60601-1/IEC 601-1/UL 2601-1
EN 61157/ IEC 61157
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.
04
EVISION
Standards Used
Standard/Directive
Chapter 1 Introduction
EMC Directive.
Medical Device Directive.
Electrostatic Discharge.
Radiated Electromagnetic Field.
Electrical Fast Transient/Burst.
Surge.
Electromagnetic Susceptibility.
Medical Electrical Equipment; General Requirements for Safety.
Requirements for the declaration of the acoustic output of medical
diagnostic ultrasonic equipment.
V
3N P
/E
IVID
RO
XPERT
Scope
S
M
ERVICE
ANUAL
1-17
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