Safety And Health Compliance - Kodak DryView 5800 Safety Manual

Safety and Related Information

Safety and Health Compliance

Safety
8
This equipment has been tested for and complies with the following
Safety and Emissions Standards. Certificates of Compliance and
Declarations of Conformity have been issued as shown below.
United States
21 CFR 1040.10 Class I
Code of Federal Regulations Title 21 Food and Drugs
Chapter I Food and Drug Administration, Department of Health and
Human Services
Volume 8 - Parts 800 to 1299
Subchapter J - Radiology Health
Part 1040 - Performance Standards for Light Emitting Products
Section 10 - Laser Products
FDA 21CFR 807 Premarket Notification 510(K): Regulatory
Requirements For Medical Devices.
UL 60950-1: Safety of Information Technology Equipment, including
Electrical Business Equipment (Bi-National Standard).
IEC 60601-1: Medical electrical equipment - Part 1: General require-
ments for safety - Section 1: Collateral standard: Safety requirements
for medical electrical systems, Clause 19.
IEC 60825-1: Safety of laser products - Part 1: Equipment classifica-
tion, requirements and user's guide.
2G0734 June 7, 2007