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DryView 8100 Laser Imager User Guide
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
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
Rest of World:
IEC 950: Safety of information technology equipment
IEC 60601–1–1: Medical electrical equipment – Part 1: General requirements for
safety – Section 1: Collateral standard: Safety requirements for medical electrical
systems
IEC 60825–1: Safety of laser products – Part 1: Equipment classification,
requirements and user's guide
vi
8754020 2000 March Rev.B
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