Dear Group
The definition of an "Active Medical Device" says that energy
transmitted "without any significant change" between device and
patient is not an active medical device. What exactly is meant by
"without significant" change?
When is an electrically powered medical device not an active one?
>Any medical device operation of which depends on a source of electrical
energy or any source of power other
>than that directly generated by the human body or gravity and which acts
by converting this energy. Medical
>devices intended to transmit energy, substances or other elements between
an active medical device and the
>patient, without any significant change, are not considered to he active
medical devices.
regards
doneirik
