BIA 450
BIA 450
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regulatory certification

FDA
Our bioimpedance devices are registered by the FDA to assess changes in electrical tissue conductivity in order to analyze body composition.

Safety Tests
Safety tests have been performed on our analyzers in accordance with applicable requirements of the Safety Standard for Medical Electrical Equipment (i.e. IEC 601-1).

Our analyzers also meet the intent of Directive 89/336/EEC for Electromagnetic Compatibility. Compliance was demonstrated with regard to the following specifications as listed in the official Journal of the European Communities:
EN 55011 Class A Radiated and Conducted Emissions
EN 60601-1-2 (1993) Immunity
   IEC 801-2    Electrostatic Discharge
   IEC 801-3    Radiated Susceptibility
   IEC 801-4    Electrical Fast Transient Burst
   IEC 801-5    Surge
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