Legal Documentation

XO FORM / XO FLOW is a combined unit and patient chair, which is to be used by dentists and other qualified personnel for prevention and treatment of human teeth diseases.

2024-02-12/KS/TLT

XO FORM & XO FLOW fulfill requirements of the following standards:

  • EN IEC 60601-1 (electrical and mechanical safety)
  • EN IEC 60601-1-2 (electromagnetic compatibility)
  • EN IEC 62304 (software process)
  • EN IEC 62366-1 (usability engineering)
  • EN IEC 50527-2-1 (electromagnetic fields and cardiac pacemakers / XO ODONTOSCALER)
  • EN 1639 (requirements for dental instruments)
  • EN 1640 (requirements for dental equipment)
  • EN 80601-2-60 (particular requirements for dental equipment)
  • EN ISO 10993-1 (biological evaluation of medical devices)
  • EN ISO 7494-1 (dental units: general requirements)
  • EN ISO 7494-2 (dental units: air, water, suction and wastewater systems)
  • EN ISO 14971 (risk management)

2024-02-12/KS/TLT