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GE H
EALTHCARE
D
FL091021, R
IRECTION
1-5-4
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
Product safety requirements for Electrical Medical devices
Class I, Type BF with CF applied parts (ICE catheter and
ECG leads).
Product safety requirements for Electrical Medical devices-
safety requirements for medical electrical systems
Product safety requirements for Electrical Medical devices-
Programmable electrical medical systems
Product safety requirements for Ultrasound system
Product EMC requirements
Group 1. Class A
Biological evaluation of medical devices
Particular requirements for the safety of electrocardiograph
monitoring equipment (Not for monitoring-only for
synchronization with ultrasound)
General requirements for basic safety and essential
performance-Usability
Patient privacy
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.
5
EVISION
Standards Used
Scope
Chapter 1 - Introduction
Standard/Directive
IEC 60601-1:1988+A1:1991+A2:1995
EN 60601-1:1990+A1:1993+A2:1995+A13:1996
UL 60601-1 (2003)
C 22.2 601-1 M90 (R2005)
IEC 60601-1-1:2000
EN 60601-1-1:2001
IEC 60601-1-4:1996+A1:1999
EN 60601-1-4:1996+A1:1999
IEC 60601-2-37:2001+A1:2004+A2:2005
EN 60601-2-37: 2001+A1:2005 +A2:2005
IEC 60601-1-2:2001+A1:2004
EN 60601-1-2:200+A1:2006
ISO 10993-1:2003
IEC60601-2-27:1994
EN60601-2-27:1994
IEC60601-1-6:2004
EN60601-1-6:2004
HIPPA Safety.
V
S
M
IVID I N
ERVICE
ANUAL
1-17
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