GE Venue 50 - Page 6

i-4 Venue 50 – Basic User Manual
Direction 5446729-100 English
Rev. 7
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 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.
• Canadian Standards Association (CSA):
• CSA 22.2, 601.1 Medical Electrical Equipment, Part 1
General Requirements for Safety.
• ANSI/AAMI ES60601-1.
• NEMA/AIUM Acoustic Output Display Standard (NEMA
UD-3, 2004).
• Medical Device Good Manufacturing Practice Manual
issued by the FDA (Food and Drug Administration,
Department of Health, USA).