GE Vivid S6 - Page 38

Safety
20 Vivid S5/Vivid S6 User Manual
R2424458-100 Rev. 2
• IEC/EN 60601-1: Medical Electrical Eqiupment, Part 1
General Requirements for Safety
• IEC/EN 60601-1-2: Medical electrical equipment -
Part 1-2: General requirements for safety - Collateral
standard: Electromagnetic compatibility - Requirements
and tests
• EN 55011/ CISPR11+A2 ED3.2: Emitted noise
according to Class B requirements + Electromagnetic
Susceptibility
• IEC/EN 60601-1-4: Medical electrical equipment - Part
1-4: General requirements for safety - Collateral
standard: Programmable electrical medical systems
• IEC/EN 60601-1-6: Medical electrical equipment - Part
1-6: General requirements for basic safety and essential
performance - Collateral Standard: Usability
• IEC/EN 60601-2-37: Medical Electrical Equipment Part
2-37: Particular Requirements for the Safety of
Ultrasonic Medical Diagnostic and Monitoring
Equipment
• EN60601-1-1: 2001 - Medical Electrical Equipment Part
1-1: General Requirements for Safety Collateral
Standard: Safety Requirements for Medical Electrical
Systems
• International Organization of Standards (ISO)
• ISO 10993-1: Biological Evaluation of Medical Devices -
Part 1: Evaluation & Testing
• ISO 10993-5: Biological Evaluation of Medical Devices -
Part 5: Tests for In Vitro Cytotoxicity
• ISO 10993-10:Biological evaluation of medical devices -
Part 10: Tests for irritation and delayed-type
hypersensitivity
• 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.