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Safety and Related Information
January 10, 2006 5E6155 1-11
Safety and Health Compliance
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.
Safety United States
Canada
21 CFR 900.12(e) Mammography Quality Standards Act; Quality
Standards; Quality Assurance for Equipment.
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 60601-1-1: 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.
CAN/CSA - C22.2 NO 60950-1-03 Information Technology Equipment -
Safety - Part 1: General Requirements. (Bi-National Standard, with
UL 60950-1).
IEC 60601-1-1: Medical electrical equipment - Part 1: General
requirements for safety - Section 1: Collateral standard: Safety
requirements for medical electrical systems, Clause 19.