General Regulatory Information; Regulatory Information - Kodak RVG 6500 IPS System Safety, Regulatory & Technical Specification User Manual

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Regulatory
Information

General Regulatory Information

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