CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02
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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 Safety
EN 60601-1-2 / IEC
60601-1-2
Medical Electrical Equipment, Part 1-2: Electromagnetic
Compatibility
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 300 330-2
Electromagnetic Compatibility and Radio Spectrum
Matters
WARNING:
Any changes or modifications not
expressly approved by the party responsible for
compliance could void the user’s authority to operate
this equipment.
