Otto Bock C-Leg compact 3C96-1 Manual page 45

CE Conformity
The electronic 3C96-1/3C86-1 C-Leg®compact Knee Joint System -Leg®compact Knee Joint System Leg®compact Knee Joint System
meets the requirements of the 93/42/EEC guidelines for medical
products. This product has been classified as a class I product
according to the classification criteria outlined in appendix IX of
the guidelines. The declaration of conformity was therefore created
by Otto Bock with sole responsibility according to appendix VII of
the guidelines.
The electronic 3C96-1/3C86-1 C-Leg®compact Knee Joint System
also meets the requirements of the 1999/5/EC guidelines for radio
equipment and telecommunications terminal equipment. Conformity
assessment was carried out by Otto Bock according to appendix II and
appendix III of the guidelines. A copy of the declaration of conformity
can be requested from the manufacturer (see back side).
45