CONFORMITY WITH REGULATIONS
Tua Face Fitness bears the CE mark.
Tua Face Fitness has been designed and manufactured in conformity with the requirements of
the Company Quality System according to ISO 9001 and ISO 13485 standards.
The device complies with the electrical safety to IEC 60601-1 Medical electrical equipment–
Part 1 General requirements to safety.
The device complies to IEC 60601-2-10 with Medical electrical equipment - Requirements for
the safety of nerve and muscle.
The Facial Wand used in the device comply with ISO 10993-1 “Biological evaluation of
medical devices”, ISO 10993-5: for in vitro cytotoxicity, and with ISO10993-10: for irritation
Intracutaneous; Skin Sensitization; Cytotoxicity-Elution method.
Conformity with electromagnetic compatibility has been determined by applying standard
IEC 60601-1-2.
30
