Certifications; Original Documentation - GE LOGIQ V2 User Manual
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Also See for LOGIQ V2:
- Technical publication (127 pages) ,
- Basic service manual (317 pages)
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Conformance Standards (continued)
Certifications
Original Documentation
i-4
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International Electrotechnical Commission (IEC).
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IEC/EN 60601-1 Medical Electrical Equipment, Part 1
General Requirements for Safety.
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IEC/EN 60601-1-2 Electromagnetic compatibility -
Requirements and tests.
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IEC/EN 60601-1-6 (Usability), EN 1041 (Information
supplied with medical devices)
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IEC/EN 60601-2-37 Particular requirements for the
safety of ultrasonic medical diagnostic and monitoring
equipment.
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International Organization of Standards (ISO)
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ISO 10993-1 Biological evaluation of medical devices.
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ANSI/AAMI ES60601-1 Medical Electrical Equipment, Part
1 General Requirements for Safety.
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Canadian Standards Association (CSA).
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CSA 22.2, 601.1 Medical Electrical Equipment, Part 1
General Requirements for Safety.
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NEMA/AIUM Acoustic Output Display Standard (NEMA
UD3).
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Medical Device Good Manufacturing Practice Manual
issued by the FDA (Food and Drug Administration,
Department of Health, USA).
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General Electric Medical Systems is ISO 13485 certified.
•
The original document was written in English.
LOGIQ V2/LOGIQ V1
Direction 5610736-100 Rev. 9
–
User Guide
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