GE HEALTHCARE
DIRECTION FQ091013, REVISION 1 VIVID I N AND VIVID Q N SERVICE MANUAL
1-22 Section 1-5 - EMC, EMI, and ESD
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:
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 1-9 Standards Used
Scope Standard/Directive
Product safety requirements for Electrical Medical devices
Class I, Type B with BF and CF applied parts
(ICE catheter and ECG leads)
IEC 60601-1
EN 60601-1
UL 60601-1
C 22.2 601-1 M90
Product safety requirements for Electrical Medical devices
- safety requirements for medical electrical systems
IEC 60601-1-1
EN 60601-1-1
Product safety requirements for Electrical Medical devices
- programmable electrical medical systems
IEC 60601-1-4
EN 60601-1-4
Product safety requirements for Ultrasound systems
IEC 60601-2-37
EN 60601-2-37
Product EMC requirements
Group 1. Class B
IEC 60601-1-2
EN 60601-1-2
Biological evaluation of Medical devices ISO 10993-1
General requirements for basic safety and essential performance
- usability
IEC60601-1-6
EN60601-1-6
Patient privacy HIPPA
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