GE LOGIQ E9

i-4 LOGIQ E9 – User Guide
Direction 5454884-100 English
Rev. 1
Conformance Standards (continued)
• International Electrotechnical Commission (IEC).
• IEC/EN 60601-1 Medical Electrical Eqiupment, Part 1
General Requirements for Safety.
• IEC/EN 60601-1-1 Safety requirements for medical
electrical systems.
• IEC/EN 60601-1-2 Electromagnetic compatibility -
Requirements and tests.
• IEC/EN 60601-1-4 Programmable electrical medical
systems.
• IEC 60601-1-6 (Usability), EN 1041 (Information
supplied with medical devices)
• IEC 60601-2-37 Medical electrical equipment. 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.
• Underwriters’ Laboratories, Inc. (UL), an independent
testing laboratory.
• UL 60601-1 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
UD-3).
• Medical Device Good Manufacturing Practice Manual
issued by the FDA (Food and Drug Administration,
Department of Health, USA).