Certifications

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Safety Conformity

Safety Conformance

  • ASTM E1965-1998
  • EN 980: Graphical symbols for use in the labeling of medical devices
  • EN 1041:Information supplied by the manufacturer with medical devices
  • EN 60601-1: Medical electrical equipment Part 1: General requirements for safety (IEC: 60601-1:1998)
  • EN 60601-1-2: Medical electrical equipment Part 1-2: General requirements for safety Collateral standard Electromagnetic compatibility Requirements and test (IEC 60601-1-2:2001)