Safety And Health Compliance; Safety - Kodak DryView 8150 Safety Manual

Safety and Related Information

Safety and Health Compliance

Safety

1-8
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: FDA CDRH Code of Federal Regulations Title 21
Food and Drugs, Volume 8 - Food and Drugs, Part 1040 - Performance
Standards for Light Emitting Products, Section 10 - Laser Products.
FDA 95-415 Premarket Notification 510(K): Regulatory Requirements For
Medical Devices.
UL 60950-1: Safety of Information Technology Equipment. (3rd Edition)
UL 60601-1-1: Medical electrical equipment - Part 1: General
requirements for safety - Section 1: Collateral standard: Safety
requirements for medical electrical systems, Clause 19.
IEC 60825-1: Safety of laser products - Part 1: Equipment classification,
requirements and user's guide.
Canada
C22.2 NO 60950-1 CAN/CSA, Safety of Information Technology Equipment,
Including Electrical Business Equipment (Gen Instr 1) (UL 1950-95).
IEC 60825-1: Safety of Laser products - Part 1: Equipment classification,
requirements and user's guide.
Europe
EN60950-1: Safety of Information Technology Equipment, Including
Electrical Business Equipment (2000).
EN60601-1-1: Medical electrical equipment - Part 1: General
requirements for safety - Section 1: Collateral standard: Safety
requirements for medical electrical systems, Clause 19.
EN60825-1: Safety of laser products - Part 1: Equipment classification,
requirements and user's guide.
7F3779 September 27, 2004