Safety And Health Compliance; Safety Standards - Konica Minolta DRYPRO SIGMA Installation Manual

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.

Safety Standards

United States
• FDA 21CFR 807 Subpart E - Premarket Notification Procedures.
• 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
• UL 60601-1:2003—Medical Electrical Equipment. General Requirements for Safety.
• ANSI/AAMI ES60601-1:2005—Medical Electrical Equipment. Part 1: General
requirements for basic safety and essential performance.
Canada
• CAN/CSA–C22.2 No. 606.1–M90, 2005 (Medical Electrical Equipment - Part 1: General
Requirements for Safety).
• CSA C22.2 NO 60601-1 CAN/CSA:2008–Medical electrical equipment–Part 1: General
requirements for basic safety and essential performance.
Europe
EN60601-1:2006–Medical electrical equipment–Part 1: General requirements for basic
safety and essential performance.
International
• IEC 60601-1:1988–Medical Electrical Equipment. General Requirements for Safety.
• IEC 60601-1:2005–Medical electrical equipment–Part 1: General requirements for
basic safety and essential performance.
• IEC 60825-1:2007 Safety of laser products–Part 1: Equipment classification and
requirements.
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Safety and Health Compliance
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