i-4 Versana Essential – User Guide
5759238-100 English
Rev. 2
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 62366(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).
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