User's Manual

Agency, Regulatory and CE Marking Compliance
ix
2001 March Rev. B 8599110
Agency, Regulatory and CE Marking Compliance
This equipment has been tested for and complies with the following Safety and
Emission Standards. Certificates of Compliance and Declarations of Conformity
have been issued as shown below.
Safety:
Canada:
 C22.2 NO 950-95–CAN/CSA Safety for Information Technology Equipment,
Including Electrical Business Equipment
 C22.2 NO 601.1–M90–CAN/CSA Medical Electrical Equipment – Part 1:
General Requirements for Safety
 CSA–CS–03: Rules for Telecommunication Equipment
Europe:
 EN60950: Safety of Information Technology Equipment, Including Electrical
Business Equipment (IEC 60950 : 1991, Modified) (Includes Amendment A1 and
A2: 1993)
 EN60601–1–1: Medical electrical equipment – Part 1: General requirements for
safety – Section 1: Collateral standard: Safety requirements for medical electrical
systems
 EN60825–1: Safety of laser products – Part 1: Equipment classification,
requirements and user’s guide
U.S.A.:
 UL 1950: Safety of Information Technology Equipment, Including Electrical
Business Equipment DOD (Bi–National Standard) with UL 2601–1 Medical
Electrical Equipment, Part 1: General Requirements for Safety
 21CFR1040.10 Class I: FDA CDRH Code of Federal Regulations Title 21,
Volume 8, Food and Drugs, Part 1040 Performance Standards For
Light–Emitting Products, Section 10 Laser Products
 FDA Premarket Notification 510(K): Regulatory Requirements For Medical
Devices
 47 CFR Part 68: FCC Rules for Telecommunication Equipment