Safety And Health Compliance; Safety - Kodak DryView 8900 User Manual

Safety and Related Information

Safety and Health Compliance

Safety

1-10
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, Chapter I Subchapter J 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: Safety of Information Technology Equipment, including
Electrical Business Equipment (Bi-National Standard).
IEC 60601-1-1 Medical electrical equipment - Part 1: General
requirements for safety - Section : Collateral standard: Safety requirements
for medical electrical systems.
IEC 60825-1: Safety of laser products - Part 1 : Equipment classification,
requirements and user's guide.
Canada
C22.2 NO 950-95-CAN/CSA, Safety of Information Technology Equipment,
Including Electrical Business Equipment (Gen Instr 1) (UL 1950-95).
IEC 60601-1-1 Medical electrical equipment – Part 1: General
requirements for safety – Section : Collateral standard: Safety
requirements for medical electrical systems.
IEC 60825-1: Safety of Laser products – Part 1: Equipment classification,
requirements and user's guide.
Europe
EN60950: Safety of Information Technology Equipment, Including
Electrical Business Equipment (IEC 60950: 1991, Modified) (Includes
Amendment A1, A2, A3, A4, and A11).
5E6155 June 12, 2003