XO FLOW is designed by dentists and other qualified personal for prevention and treatment of human teeth diseases.
XO FLOW fulfills 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)