The declaration of conformity in the device manual states that the g.BSamp amplifiers meet the following standards:
EN60601-1:1990+A1:1993+A2:1995+A12+A13:1996
EN60601-2-26 2003
EN 60601-1-2/1993
EN 60601-2-25/1995 + A1/1999
Under these standards, the device meets the following classifications.
Safety class II
Type of applied part BF (Body Protection)
Protection against mechanical distortion and liquids IP22
Operation mode S1 (permanent operation)
Conformity class IIa
Type of applied part BF (Body Protection)
Protection against mechanical distortion and liquids IP22
Operation mode S1 (permanent operation)
Conformity class IIa