i-4
LOGIQ V2/LOGIQ V1
–
User Guide
Direction 5610736-100
Rev. 9
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/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).
Certifications
•
General Electric Medical Systems is ISO 13485 certified.
Original Documentation
•
The original document was written in English.
Summary of Contents for LOGIQ V2
Page 8: ...i 6 LOGIQ V2 LOGIQ V1 User Guide Direction 5610736 100 Rev 9...
Page 92: ...Getting Started 1 80 LOGIQ V2 LOGIQ V1 User Guide Direction 5610736 100 Rev 9...
Page 242: ...After the Exam is Over 3 80 LOGIQ V2 LOGIQ V1 User Guide Direction 5610736 100 Rev 9...
Page 288: ...Safety 4 46 LOGIQ V2 LOGIQ V1 User Guide Direction 5610736 100 Rev 9...
Page 380: ...Index 4 LOGIQ V2 LOGIQ V1 User Guide Direction 5610736 100 Rev 9...
Page 381: ......
