GE LOGIQ 7, Basic User Manual

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4 LOGIQ 7 Basic User Manual
Direction 2392206-100 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 61157 Declaration of acoustic output parameters.
• International Organization of Standards (ISO)
•
ISO 10993-1 Biological evaluation of medical devices.
• Underwriters’ Laboratories, Inc. (UL), an independent
testing laboratory.
•
UL 2601-1 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
US-3, 1998).
• 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 9001 and
EN 46001 certified.
Original Documentation
• The original document was written in English.