Kodak 9000C - Technical Specifications; Compliance with International Standards

KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed 01 7–1
Chapter 7
TECHNICAL SPECIFICATIONS
Compliance with International Standards
The KODAK 9000C and KODAK 9000C 3D digital imaging unit is compliant with the
International and EEC standards.
Manufactured by:
TROPHY
4, Rue F. Pelloutier, Croissy-Beaubourg
77435 Marne la Vallée Cedex 2, France
For: Carestream Health, Inc.
150 Veronal Street
Rochester,
New York - USA 14608
Model
KODAK 9000C 3D and KODAK 9000C
Compliance with International Regulations
• Medical Device directives 93/42/ European Economic Community (EEC), Class II b
• ElectroMagnetic Compatibility (EMC) directive 89/336/EEC
• FDA Center for Devices & Radiological Health (CDRH-21CFR title 21 sub chapter J)
(USA)
• Radiation Emitting Devices Act - C34 (Canada)
• Medical Devices Regulations (Canada)
Compliance with European and International Standards
• EN 60601-1 / IEC 60601-1
• EN 60601-1-3 / IEC 60601-1-3
• EN 60601-2-7 / IEC 60601-2-7
• EN 60601-2-28 / IEC 60601-2-28
• EN 60601-1-4 / IEC 60601-1-4
• CSA 601.1
• UL 60601.1
• EN ISO 14971