Sorry don't have an answer but I'm dying to know where on the patient
you're going to put the labels and warning info!
Gary McInturff
-----Original Message-----
From: [email protected] [SMTP:[email protected]]
Sent: Tuesday, August 25, 1998 5:52 AM
To: [email protected]
Subject: AIMD
I am looking for the EMC requirements for active-implantable
medical
devices (such as an artificial kidney). The unit is driven by
electronics
which is implanted. The unit contains a battery which is used
for back-up
and the main source of power is external which is coupled to the
implanted
device through induction (at 30 MHz).
In talking to the FCC, they have rulled that the implanted
portion is
exempt from Part 15 (citing 15.103e) and that the external power
unit falls
under Part 18.
Questions:
1. Does the FDA impose additional EMC requirements?
2. What are the EMC requirements for the Union (EU)?
3. Is there a human body model for such devices?
4. Should human body attenuation be taken into consideration for
emissions?
5. Are we talking TCF on such devices?
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