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? --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], or [email protected] (the list administrators).
