Kodak RVG 6500 IPS System - Imaging Software Overview; Computer System Requirements

KODAK RVG 6500 System_Regulatory User Guide (SM737)_Ed01B
2 Regulatory
Information
General Regulatory Information
Compliance with European and International Standards
EN 60601-1 / IEC
60601-1
Medical Electrical Equipment, Part 1 : General
requirements for basic safety and essential
performance
EN 60601-1-2 / IEC
60601-1-2
Medical Electrical Equipment, Part 1-2 :General
requirements for basic safety and essential
performance - Collateral Standard : Electromagnetic
Compatibility
EN 60601-1-3 / IEC
60601-1-3
Medical Electrical Equipment, Part 1-3 : General
requirements for basic safety and essential
performance - Collateral Standard : Radiation
protection in diagnostic X-ray equipment
EN 60601-1-6 / IEC
60601-1-6
Medical Electrical Equipment, Part 1-6 : General
requirements for basic safety and essential
performance - Collateral Standard :Usability
EN ISO 14971
Medical devices - Application of risk management to
medical devices
EN 980 Symbols for use in the labeling of medical devices
EN 1041
Information supplied by the manufacturer of medical
devices
EN 62304/IEC 62304
Medical device software - Software life cycle
processes
EN 10993-1
Biological evaluation of medical devices - Part 1 :
Evaluation and testing