Kodak DryView 8900 manual Safety and Health Compliance, Canada

Safety and Related Information

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

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.

Canada

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.

January 10, 2006 5E6155 1-11