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DryView 8600 User Guide
Japan:
CISPR Group 1 Class B
USA:
47CFR15B Class B (Conducted and Emitted EMI/RFI Specs)
FDA: 21CFR CH-1. SCH-J. Part 1040 (Performance Standards for Light
Emitting Products)
UL 2601-1 (Medical and Dental Equipment)
IEC 601-1 (Medical Device Safety)
IEC 601-1-1 (EMC for Medical Devices)
IEC 825-1 (Laser Safety)
ROW:
CISPR 11 Group 1 Class B (Conducted and Emitted EMI/RFI Specs)
IEC 1000-4-2, 3, 4, 5, 6, 8, and 11
CE Marking:
This equipment is part of a medical system and conforms to the medical safety and
EMC in EN60601-1-1, EN60601-1-2, and the 93/42/EEC, MDD (Medical Device
Directive).
A Technical File and Declaration of Conformity with the Essential Requirements of
the Medical Device Directive have been prepared and signed by the appropriate
personnel and are located at:
Kodak AG
Quality Services and Product Safety
70323 Stuttgart Germany
Telephone 49-0711-40-06-5291
vi
8186546
1999 June Rev. A
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