GE LOGIQ V1 - Certifications; Original Documentation

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