Chapter 2 Regulatory Information; Applicable Regulations And Standards - GE Revolution CT User Manual

Chapter 2 Regulatory Information

1 Applicable Regulations and Standards

The system is classified as a Class , IPX0 equipment, not suitable for use in the presence of a
flammable anaesthetic mixture with oxygen or nitrous oxide. It is rated for continuous operation
with intermittent loading, with the maximum permissible ratings. No sterilization is applied. The
patient table cradle and patient support accessories are considered Type B applied parts. The
integrated cardiac module is considered a Type CF applied part.
This product complies with the requirements of the following regulations and standards:
Code of Federal Regulations, Title 21, Part 820 — Quality System Regulation
Code of Federal Regulations, Title 21, Subchapter J — Radiological Health
Federal U.S. law restricts this device for sale by or on the order of a physician.
GE Medical Systems is ISO 9001 and ISO 13485 certified.
The Revolution CT system complies with IEC 60601-1:1988, UL60601-1, EN60601-1:1990.
The Revolution CT system complies with IEC 60601-1:2005, ES60601-1, EN60601-1:2006.
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All portions of the Revolution CT system are suitable for use in the patient environment.
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The system should be used only with GE approved equipment.
The Revolution CT system complies with IEC 60601-1-1:2000.
• All portions of the Revolution CT system are suitable for use in the patient environment.
•
The system should be used only with GE approved equipment.
The Revolution CT system complies with radiation protection in accordance with IEC
60601-1-3:2008.
The Revolution CT system complies with radiation protection in accordance with IEC
60601-1-3:1994.
The Revolution CT system complies with IEC 60601-2-28. X-ray source assembly Performix
HDw Tube Unit Assembly IEC 60601-2-28 (1993).
The Revolution CT system complies with IEC 60601-2-28. X-ray tube assembly Performix HDw
Tube Unit Assembly IEC 60601-2-28:2010.
The Revolution CT system complies with IEC 60601-2-44. CT SCANNER Revolution CT IEC
60601-2-44:2001.
The Revolution CT system complies with IEC 60601-2-44. CT SCANNER Revolution CT
System IEC 60601-2-44:2009.
The Revolution CT system complies with IEC 60601-2-32. Associated Equipment Patient Table
IEC 60601-2-32:1994.
The Revolution CT system complies with IEC 60601-1-2: 2004, IEC 60601-1-2: 2007. Detailed
information concerning Electromagnetic Compatibility can be found in the Electromagnetic
Compatibility chapter of the Technical Reference Manual.
Chapter 2 Regulatory Information
Revolution CT User Manual
Direction 5480385-1EN, Revision 1
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